机构名称:上海市同济医院检验科
ISO 15189 认可证书 CNAS-PD20/10-B/2
机构名称:上海市同济医院检验科
注册号:MT0046
地 址:
A:上海市普陀区新村路389号
获准认可能力索引
序号 地址 能力范围 评审类型 更新时间
1 授权签字人(中文) 复评+扩项 2012年12月21日
2 授权签字人(英文) 复评+扩项 2012年12月21日
A
3 授权签字人(中文) 监督+扩项 2014年02月07日
4 授权签字人(英文) 监督+扩项 2014年02月07日
5 检验能力(中文) 复评+扩项 2012年12月21日
6 检验能力(英文) 复评+扩项 2012年12月21日
A
7 检验能力(中文) 监督+扩项 2014年02月07日
8 检验能力(英文) 监督+扩项 2014年02月07日
No. CNAS MT0046 第1页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Name:Department of Laboratory Medicine, Tongji Hospital of
Shanghai
Registration No.:MT0046
ADDRESS:
A: No.389, Xincun Road, Putuo District, Shanghai, China
INDEX OF ACCREDITED SIGNATORIES
No. Address Range Type Update date
Reassessment+
1 Approved signatories (Chinese) Extending 2012-12-21
assessment
Reassessment+
2 Approved signatories (English) Extending 2012-12-21
assessment A Surveillance+E
3 Approved signatories (Chinese) xtending 2014-02-07
assessment
Surveillance+E
4 Approved signatories (English) xtending 2014-02-07
assessment
Reassessment+ACCREDITED 5 Extending 2012-12-21 EXAMINATION(Chinese) assessment
Reassessment+ACCREDITED 6 Extending 2012-12-21 EXAMINATION(English) assessment A Surveillance+EACCREDITED 7 xtending 2014-02-07 EXAMINATION(Chinese) assessment
Surveillance+EACCREDITED 8 xtending 2014-02-07 EXAMINATION(English) assessment
No. CNAS MT0046 第2页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
中国合格评定国家认可委员会
实 验 室 认 可 证 书 附 件
(注册号:CNAS MT0046) 名称:上海市同济医院检验科
地址:上海市普陀区新村路389号
签发日期:2012年12月21日 有效期至:2015年12月20日 更新日期:2012年12月21日
附件1 认可的授权签字人及领域
序号 姓 名 授权签字领域 备 注
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I
?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?
Z); 1 万海英
?5免疫学检查(?A?B?C?D?E?F?G?H?I
?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I 2 郑伟萍 ?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?
Z);
No. CNAS MT0046 第3页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 姓 名 授权签字领域 备 注
?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6微生物学检查(?A?B?C?Z); 2 郑伟萍 ?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?
Z); 3 杨凡
?5免疫学检查(?A?B?C?D?E?F? G?H?I?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?
4 单咏梅 Z);
?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?Z);
5 马丽 ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
No. CNAS MT0046 第4页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 姓 名 授权签字领域 备 注
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?Z);
6 徐红菊 ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?Z);
7 戴燕 ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z);
?2血液学检查(?A?B?C?Z);
?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?Z);
8 张志英 ?5免疫学检查(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z); 9 肖倩茹 ?2血液学检查(?A?B?C?Z);
No. CNAS MT0046 第5页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 姓 名 授权签字领域 备 注
?3生化学检验(?A?B?C?D?E?F?G?H?I
?J?K?L?M?Z);
?4内分泌学检查(?A?B?C?D?E?F?G?H?
Z);
?5免疫学检查(?A?B?C?D?E?F?G?H?I 9 肖倩茹 ?J?K?Z);
?6微生物学检查(?A?B?C?Z);
?7病理学检查(?A?B?C?D?Z);
?8其他检查(?A?B?C?Z)。
No. CNAS MT0046 第6页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT
APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE
(Registration No. CNAS MT0046) NAME:Department of Laboratory Medicine, Tongji Hospital of
Shanghai
ADDRESS:No.389, Xincun Road, Putuo District, Shanghai, China Date of Issue:2012-12-21 Date of Expiry:2015-12-20
Date of Update:2012-12-21
APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE
? Name Authorized Scope of Signature Notes
?1 Body Fluid Examination(?A?B?C
?Z);
?2 Clinical Hematology(?A?B?C?
Z);
?3 Clinical Biochemistry(?A?B?C?D
?E?F?G?H?I?J?K?L?M?Z);
?4 Clinical Endocrinology(?A?B?C?1 Haiying Wan D?E?F?G?H?Z);
?5 Clinical Immunology(?A?B?C?D
?E?F?G?H?I?J?K?Z);
?6 Clinical Microbiology(?A?B?C?
Z);
?7 Pathology(?A?B?C?D?Z);
?8 Other Examination(?A?B?C?Z)。
?1 Body Fluid Examination(?A?B?C
?Z);
?2 Clinical Hematology(?A?B?C?2 Weiping Zheng Z);
?3 Clinical Biochemistry(?A?B?C?D
?E?F?G?H?I?J?K?L?M?Z);
No. CNAS MT0046 第7页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
? Name Authorized Scope of Signature Notes
?4 Clinical Endocrinology(?A?B?C? D?E?F?G?H?Z);
?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z);
2 Weiping Zheng ?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z);
?2 Clinical Hematology(?A?B?C?Z);
?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?D?E?F?G?H?Z); 3 Fan Yang
?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z);
?2 Clinical Hematology(?A?B?C?Z);
?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?4 Yongmei Shan D?E?F?G?H?Z);
?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z); 5 Li Ma ?2 Clinical Hematology(?A?B?C?Z);
No. CNAS MT0046 第8页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
? Name Authorized Scope of Signature Notes
?3 Clinical Biochemistry(?A?B?C?D ?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?D?E?F?G?H?Z);
?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z); 5 Li Ma
?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z);
?2 Clinical Hematology(?A?B?C?Z);
?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?D?E?F?G?H?Z); 6 Hongjiu Xu
?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z);
?2 Clinical Hematology(?A?B?C?Z);
?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?7 Yan Dai D?E?F?G?H?Z);
?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C 8 Zhiying Zhang ?Z);
No. CNAS MT0046 第9页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
? Name Authorized Scope of Signature Notes
?2 Clinical Hematology(?A?B?C? Z);
?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?D?E?F?G?H?Z);
?5 Clinical Immunology(?A?B?C?D8 Zhiying Zhang
?E?F?G?H?I?J?K?Z);
?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。 ?1 Body Fluid Examination(?A?B?C ?Z);
?2 Clinical Hematology(?A?B?C?Z);
?3 Clinical Biochemistry(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4 Clinical Endocrinology(?A?B?C?D?E?F?G?H?Z); 9 Qianru Xiao
?5 Clinical Immunology(?A?B?C?D?E?F?G?H?I?J?K?Z);
?6 Clinical Microbiology(?A?B?C?Z);
?7 Pathology(?A?B?C?D?Z); ?8 Other Examination(?A?B?C?Z)。
No. CNAS MT0046 第10页 共106页
The scope of the accreditation in Chinese remains the definitive version.
ISO 15189 认可证书 CNAS-PD20/10-B/2
中国合格评定国家认可委员会
实 验 室 认 可 证 书 附 件
(注册号:CNAS MT0046)
名称:上海市同济医院检验科
地址:上海市普陀区新村路389号
认可依据:ISO 15189:2007以及CNAS特定认可要求
签发日期:2012年12月21日 有效期至:2015年12月20日
更新日期:2012年12月21日
附件2 认可的检验能力范围
序号 检验项目 样品类型 领域代码 检验方法 说明
1A030-1351-0分光反射测1 比密 尿液 03-291-01 试法
1A010-1351-0分光反射测尿液 03-291-01 试法
3A010-3152-02 蛋白质 血浆 双缩脲法 22-291-01
3A010-1352-0血清 双缩脲法 23-271-01
1A020-1351-0分光反射测尿液 03-291-01 试法
3D010-1352-0葡萄糖氧化3 葡萄糖 22-291-01 酶法 血浆 3D010-1352-0电极葡萄糖 22-261-01 氧化酶法
1A080-1351-0分光反射测4 亚硝酸盐 尿液 03-291-01 试法
1A050-1351-0分光反射测5 胆红素 尿液 03-291-01 试法
No. CNAS MT0046 第11页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
3J010-3152-0血浆 重氮法 22-291-01 5 胆红素 3J010-1352-0血清 重氮法 23-271-01
1A040-1351-0分光反射测6 尿胆原 尿液 03-291-01 试法
1A035-1351-0分光反射测7 酸碱度 尿液 03-291-01 试法
1A060-1351-0分光反射测8 酮体 尿液 03-291-01 试法
1A075-1351-0分光反射测9 白细胞酯酶 尿液 03-291-01 试法
1A100-1351-0分光反射测10 隐血 尿液 03-291-01 试法
流式细胞计 1A105-7686-0数 11 白细胞定量 尿液 03-662-01 计数
流式细胞计 1A105-7686-0数 12 红细胞定量 尿液 03-662-01 计数
流式细胞计 1A105-1352-0数 13 上皮细胞定量 尿液 03-662-01 计数
流式细胞计 1A105-1352-0数 14 尿管型定量 尿液 03-662-01 计数
原证书附2A010-7682-0流式细胞计15 白细胞计数 全血 件第2019-301-01 数 项
白细胞分类计2A160-7682-0荧光染色、流16 全血 扩项 数 19-301-01 式细胞计数
原证书附2A020-7686-0流式细胞计17 红细胞计数 全血 件第2119-301-01 数 项
原证书附2A050-7684-0流式细胞计18 血小板 全血 件第2219-301-01 数 项
原证书附2A030-1352-019 血红蛋白 全血 比色法 件第2319-301-01 项
原证书附2A040-1352-0流式细胞计20 红细胞比容 全血 件第2419-301-01 数 项 No. CNAS MT0046 第12页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附平均红细胞体2A060-1352-021 全血 计算所得 件第25积 19-301-01 项
原证书附平均红细胞血2A070-1352-022 全血 计算所得 件第26红蛋白含量 19-301-01 项
原证书附平均红细胞血2A080-1352-023 全血 计算所得 件第27红蛋白浓度 19-301-01 项
原证书附2A070-1352-024 血细胞形态学 全血 光学法 件第2819-301-01 项
原证书附3H015-1352-0血浆 电极电势法 件第3122-261-01 项 25 钾 原证书附3H015-1352-0间接电位测血清 件第3123-261-01 定法 项
原证书附3H010-1352-0血浆 电极电势法 件第3222-261-01 项 26 钠 原证书附3H010-1352-0间接电位测血清 件第3223-261-01 定法 项
原证书附3H020-1352-0血浆 电极电势法 件第3322-261-01 项 27 氯 原证书附3H020-1352-0间接电位测血清 件第3323-261-01 定法 项
原证书附3H030-1352-0血浆 比色法 件第3422-291-01 项 28 总钙 原证书附3H030-1352-0间接电位测血清 件第3423-261-01 定法 项
原证书附3C025-1352-0血浆 酶法 件第3522-291-01 项 29 尿素 原证书附3C025-1352-0血清 酶电导率法 件第3523-264-01 项
原证书附3C015-1352-030 肌酐 血浆 比色法 件第3622-291-01 项
原证书附3C015-1352-030 肌酐 血清 苦味酸法 件第3623-271-01 项 No. CNAS MT0046 第13页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附3A015-7052-0血浆 溴甲酚绿法 件第3722-291-01 项 31 白蛋白 原证书附3A015-7052-0血清 溴甲酚紫法 件第3723-271-01 项
原证书附3B045-3152-0血浆 速率法 件第3822-291-01 丙氨酸氨基转项 32 移 酶 原证书附3B045-1352-0血清 连续监测法 件第3823-272-01 项
原证书附3B035-3152-0血浆 速率法 件第3922-291-01 天门冬氨酸转项 33 移 酶 原证书附3B035-1352-0血清 连续监测法 件第3923-272-01 项
原证书附3B160-3152-034 淀粉酶 血浆 速率法 件第4022-291-01 项
原证书附3B010-3152-0血浆 速率法 件第4122-291-01 项 35 肌酸激酶 原证书附3B010-1352-0血清 连续监测法 件第4123-272-01 项
原证书附3B050-3152-0血浆 速率法 件第4222-291-01 项 36 乳酸脱氢酶 原证书附3B050-1352-0连续监测法血清 件第4223-272-01 ,LD-L法, 项
原证书附凝血酶原时间2B030-3152-037 血浆 血浆凝固法 件第43测定 22-292-01 项
原证书附国际正常化PT2B030-3152-038 血浆 计算所得 件第44比值 22-292-01 项
原证书附活化部分凝血2B020-3152-039 血浆 血浆凝固法 件第45活酶时间测定 22-292-01 项
原证书附纤维蛋白原测2B100-7180-040 血浆 血浆凝固法 件第46定 22-292-01 项
原证书附5D015-7080-041 甲胎蛋白 血清 电化学发光 件第4723-051-01 项 No. CNAS MT0046 第14页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附5D010-7356-042 癌胚抗 原 血清 电化学发光 件第4823-051-01 项
原证书附5D100-7770-043 糖类抗原12-5 血清 电化学发光 件第4923-051-01 项
原证书附5D130-7775-044 糖类抗原19-9 血清 电化学发光 件第5023-051-01 项
原证书附5D120-7748-045 糖类抗原15-3 血清 电化学发光 件第5123-051-01 项
原证书附5B023-7260-046 补 体 C3 血清 散射比浊法 件第5223-061-01 项
原证书附5B024-7266-047 补 体 C4 血清 散射比浊法 件第5323-061-01 项
原证书附超敏C反应蛋5C070-7086-048 血清 散射比浊法 件第54白 23-061-53 项
原证书附免疫球蛋白5A015-7003-049 血清 散射比浊法 件第55IgA 23-061-52 项
原证书附免疫球蛋白5A010-7002- 50 血清 散射比浊法 件第56IgG 023-061-51 项
原证书附免疫球蛋白5A020-7004-051 血清 散射比浊法 件第57IgM 23-061-53 项
原证书附5F360-1430-052 丙肝病毒抗体 血清 化学发光法 件第5823-051-21 项
原证书附
化学发光法 件第59
乙肝病毒
面5F016-8502-0项 53 血清 抗原 23-051-01 原证书附电化学发光件第59法 项
原证书附乙肝病毒表面5F015-1430-054 血清 化学发光法 件第60抗体 23-051-01 项
原证书附乙肝病毒e抗5F019-8508-055 血清 化学发光法 件第61原 23-051-01 项
原证书附乙肝病毒e抗5F019-8508-056 血清 化学发光法 件第62体 23-051-01 项 No. CNAS MT0046 第15页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附乙肝病毒核心5F015-1430-057 血清 化学发光法 件第63抗体 23-051-04 项
原证书附抗人类免疫缺5F560-1430-0酶联免疫分58 血清 件第65陷病毒抗体 23-023-04 析 项
原证书附抗梅毒螺旋体5E071-0000-059 血清 化学发光法 件第66抗体 23-051-21 项
原证书附梅毒血清学筛5E074-0000-0不加热血清60 血清 件第67查实验TRUST 23-116-11 学实验 项
原证书附3H040-1352-061 磷 血清 磷钼酸法 件第6823-272-01 项
尿酸酶-过氧原证书附3C020-1352-062 尿酸 血清 化物酶偶联件第6923-271-01 法 项
原证书附3F050-1352-063 总胆固 醇 血清 GOD-PAPF法 件第7023-271-01 项
原证书附3F015-1352-064 甘油三 酯 血清 GOD-PAP法 件第7123-271-01 项
原证书附高密度脂蛋白3F070-1352-065 血清 匀相测定法 件第72胆固醇 23-271-01 项
原证书附低密度脂蛋白3F077-1352-066 血清 匀相测定法 件第73胆固醇 23-271-01 项
原证书附3F180-7150-0免疫透射比67 载脂蛋白A1 血清 件第7423-292-01 浊法 项
原证书附3F190-7154-0免疫透射比68 载脂蛋白B 血清 件第7523-292-01 浊法 项
原证书附r,谷氨酰基3B090-1352-069 血清 连续监测法 件第76转移酶 23-271-01 项
原证书附3B070-1352-070 碱性磷酸酶 血清 连续监测法 件第7723-271-01 项
原证书附显微镜检查6A010-6003-071 尿液 镜检法 件第18(普通细菌) 03-704-11 项 No. CNAS MT0046 第16页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附6A010-6002-0粪便 镜检法 件第1815-704-11 项
原证书附6A010-6004-0脑脊液 镜检法 件第1841-704-11 项
原证书附6A010-6004-0胸水 镜检法 件第1842-704-11 项
原证书附6A010-6004-0腹水 镜检法 件第1843-704-11 显微镜检查项 71 (普通细菌) 原证书附6A010-6004-0痰 镜检法 件第1861-704-11 项
原证书附6A010-6004-0阴道分泌液 镜检法 件第1867-704-11 项
原证书附6A010-6004-0脓 镜检法 件第1886-704-11 项
原证书附6A010-6004-0咽喉分泌液 镜检法 件第1863-704-11 项
原证书附6A205--6004-脑脊液 镜检法 件第19041-716-11 项
原证书附6A205-6004-0胸水 镜检法 件第1942-716-11 项
原证书附6A205-6004-0腹水 镜检法 件第1943-716-11 显微镜检查项 72 ,分枝杆菌, 原证书附6A205-6001-0痰 镜检法 件第1961-716-11 项
原证书附6A205-6001-0脓 镜检法 件第1986-716-11 项
原证书附6A205-6001-0咽喉分泌液 镜检法 件第1963-716-11 项 No. CNAS MT0046 第17页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、志贺
氏菌属、
沙门氏菌
属、枸橼
酸杆菌培养和鉴定6B010-6003-0常规培养~仪属、变形73 尿液 ,普通细菌, 03-741-11 器鉴定 杆菌属、
克雷伯氏
菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第18页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、枸橼
酸杆菌
属、变形
杆菌属、培养和鉴定6B010-6004-0常规培养~仪73 全血 克雷伯氏,普通细菌, 18-741-11 器鉴定 菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第19页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、枸橼
酸杆菌
属、变形
杆菌属、培养和鉴定6B010-6002-0常规培养~仪73 粪便 克雷伯氏,普通细菌, 15-741-11 器鉴定 菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第20页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、志贺
氏菌属、
沙门氏菌
属、枸橼
酸杆菌培养和鉴定6B010--6004-常规培养~仪属、变形73 脑脊液 ,普通细菌, 041-744-11 器鉴定 杆菌属、
克雷伯氏
菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第21页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、志贺
氏菌属、
沙门氏菌
属、枸橼
酸杆菌培养和鉴定6B010--6004-常规培养~仪属、变形73 胸水 ,普通细菌, 042-741-11 器鉴定 杆菌属、
克雷伯氏
菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第22页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、志贺
氏菌属、
沙门氏菌
属、枸橼
酸杆菌培养和鉴定6B010--6004-常规培养~仪属、变形73 腹水 ,普通细菌, 043-741-11 器鉴定 杆菌属、
克雷伯氏
菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第23页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、志贺
氏菌属、
沙门氏菌
属、枸橼
酸杆菌培养和鉴定6B010-6001-0常规培养~仪属、变形73 痰 ,普通细菌, 61-744-11 器鉴定 杆菌属、
克雷伯氏
菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第24页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、志贺
氏菌属、
沙门氏菌
属、枸橼
酸杆菌培养和鉴定6B010-6003-0常规培养~仪属、变形73 阴道分泌液 ,普通细菌, 67-744-11 器鉴定 杆菌属、
克雷伯氏
菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第25页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
原证书附
件第15
项 能力
限于:链
球菌属、
肠球菌
属、葡萄
球菌属、
肠杆菌
属、志贺
氏菌属、
沙门氏菌
属、枸橼
酸杆菌培养和鉴定6B010-6005-0常规培养~仪属、变形73 脓 ,普通细菌, 86-741-11 器鉴定 杆菌属、
克雷伯氏
菌属、沙
雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
No. CNAS MT0046 第26页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明 能力限
于: 链球菌属、肠球菌属、葡萄球菌属、肠杆菌属、志贺氏菌
属、沙门氏菌属、枸橼酸杆菌属、变形杆菌
培养和鉴定6B010-6001-0常规培养~仪属、克雷73 咽喉分泌液 ,普通细菌, 63-744-11 器鉴定 伯氏菌
属、沙雷氏菌属、摩根氏菌属、普罗威登斯菌属、气单胞菌属、假单胞菌属、不动杆菌属、产碱杆菌属、黄杆菌属
原证书附6B090-6004-0常规培养~仪全血 件第2918-744-11 器鉴定 项
原证书附6B090-6004-0常规培养~仪脑 脊 液 件第2941-744-11 器鉴定 项 74 流感嗜血杆菌 原证书附6B090-6004-0常规培养~仪痰 件第2961-744-11 器鉴定 项
原证书附6B090-6004-0常规培养~仪咽喉分泌液 件第2963-744-11 器鉴定 项
原证书附6B075-6004-0常规培养~仪全血 件第3018-744-11 器鉴定 项
原证书附6B075-6004-0常规培养~仪脑脊液 75 肺炎链球菌 件第3041-744-11 器鉴定 项
原证书附6B075-6004-0常规培养~仪痰 件第3061-744-11 器鉴定 项
No. CNAS MT0046 第27页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明 原证书附件第78项
AST-GP67
包含药
物:氨苄青霉素、环丙沙
星、克林霉素、红霉素、庆大霉素、高浓度庆大、左氧氟沙星、利奈唑
胺、莫西沙星、呋喃妥因、苯唑西
林、奎奴普汀/达福普汀、利福平、高浓度链霉素、四环素、替吉环素~复方新诺
药敏试验,普6C010-8500-0明、万古76 菌株 MIC法 霉素,通细菌, 80-763-11 AST-GN13
包含药
物:阿米卡星、氨苄西林、氨苄西林/舒巴坦、氨曲南、头孢唑
林、头孢吡肟、头孢替坦、头孢他
啶、头孢曲松、环丙沙星、氨曲南、庆大霉
素、亚胺培南、左氧氟沙
星、呋喃妥因、哌拉西林/他唑巴
坦、妥布霉素、复方新诺
明。
No. CNAS MT0046 第28页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 检验项目 样品类型 领域代码 检验方法 说明
药敏试验,普6C010-8500-076 菌株 K-B法 通细菌, 80-763-11
仪器鉴定 6B820-0000-0粪便 80-121-11 血清学分型 沙门菌培养和77 鉴定 仪器鉴定 6B820-0000-0全血 18-121-11 血清学鉴定
仪器鉴定 6B825-0000-0粪便 80-121-11 血清学分型 志贺菌培养和78 鉴定 仪器鉴定 6B825-0000-0全血 18-121-11 血清学分型
No. CNAS MT0046 第29页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT
APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE
(Registration No. CNAS MT0046)
NAME:Department of Laboratory Medicine, Tongji Hospital of
Shanghai
ADDRESS:No.389, Xincun Road, Putuo District, Shanghai, China Accreditation Criteria: ISO 15189:2007 and relevant requirements of CNAS
Date of Issue:2012-12-21 Date of Expiry:2015-12-20 Date of Update:2012-12-21
APPENDIX 2 ACCREDITED EXAMINATION
Examination Analytical ? Sample Type Code Notes Item Method
Color 1A030-1351- 1 gravity urine reflection 003-291-01 test method
Color 1A010-1351- urine reflection 003-291-01 test method
3A010-3152- 2 protein plasma Biuret method 022-291-01
3A010-1352- serum Biuret method 023-271-01
Color 1A020-1351- urine reflection 003-291-01 test method
3D010-1352- glucose 3 glucose 022-291-01 oxidase
plasma Electrode - 3D010-1352- glucose 022-261-01 oxidase
Color 1A080-1351- 4 nitrite urine reflection 003-291-01 test method
Color 1A050-1351- 5 bilirubin urine reflection 003-291-01 test method
No. CNAS MT0046 第30页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
3J010-3152- plasma Diazo method 022-291-01 5 bilirubin 3J010-1352- serum Diazo method 023-271-01
Color 1A040-1351- 6 Urobilinogen urine reflection 003-291-01 test method
Color 1A035-1351- 7 PH urine reflection 003-291-01 test method
Color 1A060-1351- 8 ketones urine reflection 003-291-01 test method
Color Leukocytes 1A075-1351- 9 urine reflection (test paper) 003-291-01 test method
Color occult blood 1A100-1351- 10 urine reflection reaction 003-291-01 test method
Flow Quantitative 1A105-7686- Cytometry 11 urine leukocyte 003-662-01
Count
Flow Quantitative 1A105-7686- Cytometry 12 urinary red urine 003-662-01 blood cells
Count
Flow quantitative 1A105-1352- Cytometry 13 Epithelial urine 003-662-01 cells
Count
Flow quantitative 1A105-1352- Cytometry 14 urine cast 003-662-01
Count
Annex 20
of the 2A010-7682-0Flow 15 leukocytes whole blood original 19-301-01 Cytometry certific
ate
Staining, items Leukocyte 2A160-7682-016 whole blood flow Expansiocount 19-301-01 cytometry, n
No. CNAS MT0046 第31页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex 21
of the 2A020-7686-0Flow 17 erythrocytes whole blood original 19-301-01 Cytometry certific
ate
Annex 22
of the 2A050-7684-0Flow 18 platelets whole blood original 19-301-01 Cytometry certific
ate
Annex
23of the 2A030-1352-019 hemoglobin whole blood Colorimetry original 19-301-01 certific
ate
Annex 24
of the 2A040-1352-0Flow 20 hematocrit whole blood original 19-301-01 Cytometry certific
ate
Annex erythrocyte 25of the mean 2A060-1352-021 whole blood Calculated original corpuscular 19-301-01 certificvolume ate
Annex 26 erythrocyte of the mean 2A070-1352-022 whole blood Calculated original corpuscular 19-301-01 certifichemoglobin ate erythrocyte Annex 27
mean of the 2A080-1352-023 corpuscular whole blood Calculated original 19-301-01 hemoglobin certificconcentration ate
Annex
28of the Blood cell 2A070-1352-0Optical 24 whole blood original morphology 19-301-01 method certific
ate
Annex
Electrode 31of the 3H015-1352-025 potassium plasma potential original 22-261-01 method certific
ate
No. CNAS MT0046 第32页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
31of the 3H015-1352-025 potassium serum original 23-261-01 certific
ate
Annex
Electrode 32of the 3H010-1352-0plasma potential original 22-261-01 method certific
ate 26 sodium Annex
32of the 3H010-1352-0serum original 23-261-01 certific
ate
Annex
Electrode 33of the 3H020-1352-0plasma potential original 22-261-01 method certific
ate 27 chloride Annex
33of the 3H020-1352-0serum original 23-261-01 certific
ate
Annex
34of the 3H030-1352-0plasma Colorimetry original 22-291-01 certific
ate 28 Calcium Annex
34of the 3H030-1352-0serum original 23-261-01 certific
ate
Annex
35of the 3C025-1352-0plasma Colorimetry original 22-291-01 certific
ate 29 urea Annex
Enzyme 35of the 3C025-1352-0serum conductivity original 23-264-01 method certific
ate
No. CNAS MT0046 第33页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
36of the 3C015-1352-0plasma Colorimetry original 22-291-01 certific
ate 30 creatinine Annex
36of the 3C015-1352-0Picric acid serum original 23-271-01 method certific
ate
Annex
37of the 3A015-7052-0Bromocresol plasma original 22-291-01 purple method certific
ate 31 albumin Annex
37of the 3A015-7052-0Bromocresol serum original 23-271-01 purple method certific
ate
Annex
38of the 3B045-3152-0velocity plasma original 22-291-01 method certificalanine ate 32 aminotransferaAnnex se Continuous 38of the 3B045-1352-0serum monitoring original 23-272-01 method certific
ate
Annex
39of the 3B035-3152-0velocity plasma original 22-291-01 method certificasparate ate 33 aminotransferaAnnex se Continuous 39of the 3B035-1352-0serum monitoring original 23-272-01 method certific
ate
Annex
40of the 3B160-3152-0velocity 34 amylase plasma original 22-291-01 method certific
ate
No. CNAS MT0046 第34页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
41of the 3B010-3152-0velocity plasma original 22-291-01 method certific
ate creatine 35 kinase Annex
Continuous 41of the 3B010-1352-0serum monitoring original 23-272-01 method certific
ate
Annex
42of the 3B050-3152-0velocity plasma original 22-291-01 method certific
ate lactate 36 dehydrogenase Annex Continuous 42of the 3B050-1352-0monitoring serum original 23-272-01 method(LD-L certificmethod) ate
Annex
Plasma 43of the prothrombin 2B030-3152-037 plasma coagulation original time 22-292-01 method certific
ate
Annex International 44of the 2B030-3152-038 Normalized plasma Calculated original 22-292-01 Ratio certific
ate
Annex activated Plasma 45of the partial 2B020-3152-039 plasma coagulation original thromboplastin 22-292-01 method certifictime ate
Annex
Plasma 46of the 2B100-7180-040 fibrinogen plasma coagulation original 22-292-01 method certific
ate
Annex
47of the Alpha- 5D015-7080- 41 serum ECL original fetoprotein 023-051-01 certific
ate
No. CNAS MT0046 第35页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
48of the Carcinoembry-o5D010-7356- 42 serum ECL original nic antigen 023-051-01 certificate
Annex
49of the Carbohydrate 5D100-7770- 43 serum ECL original antigen 12-5 023-051-01 certificate
Annex
50of the Carbohydrate 5D130-7775- 44 serum ECL original antigen 19-9 023-051-01 certificate
Annex
51of the Carbohydrate 5D120-7748- 45 serum ECL original antigen 15-3 023-051-01 certificate
Annex
52of the 5B023-7260- 46 Complement-3 serum Nephelometry original 023-061-01 certificate
Annex
53of the 5B024-7266- 47 Complement-4 serum Nephelometry original 023-061-01 certificate
Annex
54of the C-Reactive 5C070-7086- 48 serum Nephelometry original Protein 023-061-53 certificate
Annex
55of the Immunoglo 5A015-7003- 49 serum Nephelometry original bulin A 023-061-52 certificate
Annex
56of the Immunoglo 5A010-7002- 50 serum Nephelometry original bulin G 023-061-51 certificate
No. CNAS MT0046 第36页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
57of the Immunoglo 5A020-7004- 51 serum Nephelometry original bulin M 023-061-53 certific
ate
Annex
58of the hepatitis C 5F360-1430- chemilumines52 serum original virus antibody 023-051-21 cence certific
ate
Annex
59of the chemiluminesoriginal cence certificHepatitis B ate 5F016-8502- 53 virus surface serum 023-051-01 Annex antigen 59of the
ECL original
certific
ate
Annex Hepatitis B 60of the 5F015-1430- chemilumines54 surface serum original 023-051-01 cence antibody certific
ate
Annex
61of the Hepatitis B e 5F019-8508- chemilumines55 serum original antigen 023-051-01 cence certific
ate
Annex
62of the hepatitis B e 5F019-8508- chemilumines56 serum original antibody 023-051-01 cence certific
ate
Annex
63of the hepatitis B 5F015-1430- chemilumines57 serum original core antibody 023-051-04 cence certific
ate
Annex
65of the anti-HIV 5F560-1430- 58 serum ELISA original antibody tests 023-023-04 certific
ate
No. CNAS MT0046 第37页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex Anti-Treponema 66of the 5E071-0000- chemilumines59 pallidum serum original 023-051-21 cence antibody certific
ate
Annex Serological 67of the screening 5E074-0000- 60 serum Serum TEST original tests for 023-116-11 certificsyphilis ate
Annex
68of the inorganic 3H040-1352-0Phosphomolyb61 serum original phosphate 23-272-01 date method certific
ate
Annex
Uricase - 69of the 3C020-1352-062 uric acid serum peroxidase-coriginal 23-271-01 oupled method certific
ate
Annex
70of the total 3F050-1352-0GOD-PAPF 63 serum original cholesterol 23-271-01 method certific
ate
Annex
71of the 3F015-1352-0GOD-PAP 64 triglyceride serum original 23-271-01 method certific
ate
Annex
72of the HDL-cholestero3F070-1352-0Homogeneous 65 serum original l 23-271-01 assay certific
ate
Annex
73of the LDL-cholestero3F077-1352-0Homogeneous 66 serum original l 23-271-01 assay certific
ate
Annex
Immune 74of the apolipoprotein 3F180-7150-067 serum transmission original A-1 23-292-01 turbidity certific
ate
No. CNAS MT0046 第38页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
Immune 75of the apolipoprotein 3F190-7154-068 serum transmission original B 23-292-01 turbidity certific
ate
Annex
Continuous 76of the gamma glutamy1 3B090-1352-069 serum monitoring original transpeptidase 23-271-01 method certific
ate
Annex
Continuous 77of the alkaline 3B070-1352-070 serum monitoring original phosphatase 23-271-01 method certific
ate
Annex
18of the 6A010-6003-0Microscopic urine original 03-704-11 examination certific
ate
Annex
18of the 6A010-6002-0Microscopic stool original 15-704-11 examination certific
ate
Annex
18of the cerebros 6A010-6004-0Microscopic original pinal fluid 41-704-11 examination certificmicroscopic
ate examination 71 (common Annex bacteria) 18of the pleural 6A010-6004-0Microscopic original diffusion 42-704-11 examination certific
ate
Annex
18of the 6A010-6004-0Microscopic Ascites original 43-704-11 examination certific
ate
Annex
18of the 6A010-6004-0Microscopic sputum original 61-704-11 examination certific
ate
No. CNAS MT0046 第39页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
18of the vaginal 6A010-6004-0Microscopic original secretion 67-704-11 examination certific
ate
Annex microscopic 18of the examination 6A010-6004-0Microscopic 71 pus original (common 86-704-11 examination certificbacteria) ate
Annex
18of the pharyngeal 6A010-6004-0Microscopic original secretion 63-704-11 examination certific
ate
Annex
19of the 6A205-6003-0Microscopic urine original 03-716-11 examination certific
ate
Annex
19of the 6A205-6002-0Microscopic stool original 15-716-11 examination certific
ate
Annex
19of the cerebros 6A205--6004-Microscopic original pinal fluid 041-716-11 examination certificmicroscopic ate 72 examination Annex (mycobacteria) 19of the pleural 6A205-6004-0Microscopic original diffusion 42-716-11 examination certific
ate
Annex
19of the 6A205-6004-0Microscopic Ascites original 43-716-11 examination certific
ate
Annex
19of the 6A205-6001-0Microscopic sputum original 61-716-11 examination certific
ate
No. CNAS MT0046 第40页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
19of the 6A205-6001-0Microscopic pus original 86-716-11 examination certific
ate
microscopic
72 examination
(mycobacteria)
Annex
19of the pharyngeal 6A205-6001-0Microscopic original secretion 63-716-11 examination certific
ate No. CNAS MT0046 第41页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity is
limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
Conventional Salmonelculture and training, la, identification6B010-6003- 73 urine instrument genus (common 003-741-11 identificatiCitrobacbacteria) on ter,
Proteus, Klebsiella,
Serratia,
Morgan'sgenus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第42页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
genus Conventional culture and Citrobactraining, identification6B010-6004-0ter, 73 Whole blood instrument (common 18-741-11 Proteus, identificatibacteria) Klebsielon la,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter,
Alcaligenes,
Flavobacterium
No. CNAS MT0046 第43页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus,
Enterobacter,
genus Conventional culture and Citrobactraining, identification6B010-6002-0ter, 73 Stool instrument (common 15-741-11 Proteus, identificatibacteria) Klebsielon la,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第44页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identificationcerebrospina6B010--6004-genus 73 instrument (common l fluid 041-744-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第45页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identificationPleural 6B010--6004-genus 73 instrument (common diffusion 042-741-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第46页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identification6B010--6004-genus 73 Ascites instrument (common 043-741-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第47页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identification6B010-6001-0genus 73 sputum instrument (common 61-744-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第48页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptoc
occus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identificationvaginal 6B010-6003-0genus 73 instrument (common secretion 67-742-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第49页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identification6B010-6005-0genus 73 pus instrument (common 86-742-11 Citrobacidentificatibacteria) ter, on Proteus,
Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
No. CNAS MT0046 第50页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Annex
15of the
original
certific
ate
Capacity
is
limited
to:
Streptoc
occus,
Enteroco
ccus,
Staphylo
coccus,
Enteroba
cter,
Shigella
,
Conventional Salmonelculture and training, la, identificationpharyngeal 6B010-6001-073 instrument genus (common secretion 63-744-11 identificatiCitrobacbacteria) on ter,
Proteus,
Klebsiel
la,
Serratia
,
Morgan's
genus,
Providen
ce spp,
Aeromona
s,
Pseudomo
nas,
Acinetob
acter,
Alcalige
nes,
Flavobac
terium
Conventional Annex training, 29of the 6B090-6004-074 Haemophilus whole blood instrument original 18-744-11 identificaticertificon ate
No. CNAS MT0046 第51页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Conventional Annex
training, 29of the cerebros 6B090-6004-0instrument original pinal fluid 41-744-11 identificaticertific
on ate
Conventional Annex
training, 29of the 6B090-6004-074 Haemophilus sputum instrument original 61-744-11 identificaticertific
on ate
Conventional Annex
training, 29of the pharyngeal 6B090-6004-0instrument original secretion 63-744-11 identificaticertific
on ate
Conventional Annex
training, 30of the 6B075-6004-0Whole blood instrument original 18-744-11 identificaticertific
on ate
Conventional Annex
training, 30of the Streptococcus cerebrospina6B075-6004-075 instrument original Pneumoniae l fluid 41-744-11 identificaticertific
on ate
Conventional
training, 6B075-6004-0sputum instrument 61-744-11 identificati
on
Annex
78of the
original MIC method
certific
ate drug
susceptibility Bacteria 6C010-8500-076 test(Common Strains 80-763-11
bacteria)
K-B method
No. CNAS MT0046 第52页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
Examination Analytical ? Sample Type Code Notes Item Method
Instrument
identificati
on 6B820-0000-0stool 80-121-11
Serological
Culture and
77 identification
Instrument (Salmonella)
identificati
on 6B820-0000-0whole blood 18-121-11
Serological
Instrument
identificati
on 6B825-0000-0stool 80-121-11
Serological
culture and
78 identification
Instrument (Shigella)
identificati
on 6B825-0000-0whole blood 18-121-11
Serological
No. CNAS MT0046 第53页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
中国合格评定国家认可委员会
实 验 室 认 可 证 书 附 件
(注册号:CNAS MT0046)
名称:上海市同济医院检验科
地址:上海市普陀区新村路389号
签发日期:2012年12月21日 有效期至:2015年12月20日 更新日期:2014年02月07日
附件1 认可的授权签字人及领域
序号 姓 名 授权签字领域 备 注
?1一般检查(?A?B?C?Z); ?2血液学检查(?
A?B?C?Z); ?3生化学检验(?A?B?C?D?
E?F?G?H?I?J?K?L?M?Z); ?4内分泌学
检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 1 万海英 学检查(?A?B?C?D?E?F?G?H?I?J?K?
Z); ?6微生物学检查(?A?B?C?Z); ?7病
理学检查(?A?B?C?D?Z); ?8其他检查(?
A?B?C?Z)。
?1一般检查(?A?B?C?Z); ?2血液学检查(?
A?B?C?Z); ?3生化学检验(?A?B?C?D?
E?F?G?H?I?J?K?L?M?Z); ?4内分泌学
检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 2 郑伟萍 学检查(?A?B?C?D?E?F?G?H?I?J?K?
Z); ?6微生物学检查(?A?B?C?Z); ?7病
理学检查(?A?B?C?D?Z); ?8其他检查(?
A?B?C?Z)。
No. CNAS MT0046 第54页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 姓 名 授权签字领域 备 注
?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 3 杨凡 学检查(?A?B?C?D?E?F? G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 4 单咏梅 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 5 马丽 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 6 徐红菊 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。
?1一般检查(?A?B?C?Z); ?2血液学检查(?A?B?C?Z); ?3生化学检验(?A?B?C?D?E?F?G?H?I?J?K?L?M?Z); ?4内分泌学检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 7 戴燕 学检查(?A?B?C?D?E?F?G?H?I?J?K?Z); ?6微生物学检查(?A?B?C?Z); ?7病理学检查(?A?B?C?D?Z); ?8其他检查(?A?B?C?Z)。
No. CNAS MT0046 第55页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
序号 姓 名 授权签字领域 备 注
?1一般检查(?A?B?C?Z); ?2血液学检查(?
A?B?C?Z); ?3生化学检验(?A?B?C?D?
E?F?G?H?I?J?K?L?M?Z); ?4内分泌学
检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 8 张志英 学检查(?A?B?C?D?E?F?G?H?I?J?K?
Z); ?6微生物学检查(?A?B?C?Z); ?7病
理学检查(?A?B?C?D?Z); ?8其他检查(?
A?B?C?Z)。
?1一般检查(?A?B?C?Z); ?2血液学检查(?
A?B?C?Z); ?3生化学检验(?A?B?C?D?
E?F?G?H?I?J?K?L?M?Z); ?4内分泌学
检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 9 肖倩茹 学检查(?A?B?C?D?E?F?G?H?I?J?K?
Z); ?6微生物学检查(?A?B?C?Z); ?7病
理学检查(?A?B?C?D?Z); ?8其他检查(?
A?B?C?Z)。
?1一般检查(?A?B?C?Z); ?2血液学检查(?
A?B?C?Z); ?3生化学检验(?A?B?C?D?
E?F?G?H?I?J?K?L?M?Z); ?4内分泌学
检查(?A?B?C?D?E?F?G?H?Z); ?5免疫 10 李冬 学检查(?A?B?C?D?E?F?G?H?I?J?K?
Z); ?6微生物学检查(?A?B?C?Z); ?7病
理学检查(?A?B?C?D?Z); ?8其他检查(?
A?B?C?Z)。
No. CNAS MT0046 第56页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT
APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE
(Registration No. CNAS MT0046)
NAME:Department of Laboratory Medicine, Tongji Hospital of
Shanghai
ADDRESS:No.389, Xincun Road, Putuo District, Shanghai, China
Date of Issue:2012-12-21 Date of Expiry:2015-12-20 Date of Update:2014-02-07
APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE
? Name Authorized Scope of Signature Notes
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?
1 Haiying Wan A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
No. CNAS MT0046 第57页 共106页
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
? Name Authorized Scope of Signature Notes
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?2 Weiping Zheng A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?3 Fan Yang A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?4 Yongmei Shan A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
No. CNAS MT0046 第58页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
? Name Authorized Scope of Signature Notes
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?5 Li Ma A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?6 Hongjiu Xu A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?7 Yan Dai A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
No. CNAS MT0046 第59页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO 15189 认可证书 CNAS-PD20/10-B/2
? Name Authorized Scope of Signature Notes
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?8 Zhiying Zhang A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?9 Qianru Xiao A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
?1 Body Fluid Examination(?A?B?C
?Z); ?2 Clinical Hematology(?A?B
?C?Z); ?3 Clinical Biochemistry(?A
?B?C?D?E?F?G?H?I?J?K?L
?M?Z); ?4 Clinical Endocrinology(?10 Dong Li A?B?C?D?E?F?G?H?Z); ?5
Clinical Immunology(?A?B?C?D?E
?F?G?H?I?J?K?Z); ?6 Clinical
Microbiology(?A?B?C?Z); ?7
Pathology(?A?B?C?D?Z); ?8
Other Examination(?A?B?C?Z)。
No. CNAS MT0046 第60页 共106页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
中国合格评定国家认可委员会
实 验 室 认 可 证 书 附 件
(注册号:CNAS MT0046)
名称:上海市同济医院检验科
地址:上海市普陀区新村路389号
认可依据:ISO 15189:2007以及CNAS特定认可要求
签发日期:2012年12月21日 有效期至:2015年12月20日
更新日期:2014年02月07日
附件2 认可的检验能力范围
序号 检验项目 样品类型 领域代码 检验方法 说明
1A030-1351-0分光反射测1 尿比密 尿液 03-291-01 试法
1A010-1351-0分光反射测2 尿蛋白质 尿液 03-291-01 试法
1A020-1351-0分光反射测3 尿葡萄糖 尿液 03-291-01 试法
1A080-1351-0分光反射测4 尿亚硝酸盐 尿液 03-291-01 试法
1A050-1351-0分光反射测5 尿胆红素 尿液 03-291-01 试法
1A040-1351-0分光反射测6 尿胆原 尿液 03-291-01 试法
1A035-1351-0分光反射测7 尿酸碱度 尿液 03-291-01 试法
第61页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
1A060-1351-0分光反射测8 尿酮体 尿液 03-291-01 试法
1A075-1351-0分光反射测9 尿白细胞酯酶 尿液 03-291-01 试法
1A100-1351-0分光反射测10 尿隐血 尿液 03-291-01 试法
1A105-7682-0流式细胞计尿液 03-282-01 数 11 尿白细胞定量 1A1A105-1352显微镜成像 -003-701-01 技术
1A105-7686-0流式细胞计 03-282-01 数 12 尿红细胞定量 尿液 显微镜成像 技术 A11A105-7686
-003-701-01
1A105-1352-0流式细胞计 03-282-01 数
尿上皮细胞定13 尿液 显微镜成像量 技术 1A1A105-1352
-003-701-01
1A105-1352-0流式细胞计 03-282-01 数 14 尿管型定量 尿液 显微镜成像 技术 A11A105-1352
-003-701-01
2A010-7682-0荧光染色、流15 白细胞计数 全血 19-301-01 式细胞计数
白细胞分类计2A010-7682-0荧光染色、流16 全血 数 19-301-01 式细胞计数
2A020-7686-0电阻抗法、流17 红细胞计数 全血 19-301-01 式细胞计数
2A050-7684-0电阻抗法、流18 血小板 全血 19-301-01 式细胞计数
2A030-1352-019 血红蛋白 全血 比色法 19-301-01
2A040-1352-020 红细胞比容 全血 电阻抗法 19-301-01
平均红细胞体2A060-1352-021 全血 计算所得 积 19-301-01
平均红细胞血2A070-1352-022 全血 计算所得 红蛋白含量 19-301-01
平均红细胞血2A080-1352-023 全血 计算所得 红蛋白浓度 19-301-01
第62页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
2A070-1352-024 血细胞形态学 全血 光学法 19-301-01
3H015-1352-0血浆 电极电势法 22-261-01 25 钾 3H015-1352-0间接电位测血清 23-261-01 定法
3H010-1352-0血浆 电极电势法 22-261-01 26 钠 3H010-1352-0间接电位测血清 23-261-01 定法
3H020-1352-0血浆 电极电势法 22-261-01 27 氯 3H020-1352-0间接电位测血清 23-261-01 定法
3H030-1352-0血浆 比色法 22-291-01 28 钙 3H030-1352-0间接电位测血清 23-261-01 定法
3C025-1352-0血浆 酶法 22-291-01 29 尿素 3C025-1352-0血清 酶法 23-271-01
3C015-1352-0血浆 比色法 22-291-01 30 肌酐 3C015-1352-0血清 苦味酸法 23-271-01
3A015-7052-0血浆 溴甲酚绿法 22-291-01 31 白蛋白 3A015-7052-0血清 溴甲酚绿法 23-271-01
3B045-3152-0血浆 速率法 丙氨酸氨基转22-291-01 32 移 酶 3B045-1352-0血清 连续监测法 23-272-01
3B035-3152-0血浆 速率法 天门冬氨酸氨22-291-01 33 基转移 酶 3B035-1352-0血清 连续监测法 23-272-01
3B160-3152-034 淀粉酶 血浆 速率法 22-291-01
3B010-3152-0血浆 速率法 22-291-01 35 肌酸激酶 3B010-1352-0血清 连续监测法 23-272-01
3B050-3152-036 乳酸脱氢酶 血浆 速率法 22-291-01
3B050-1352-0连续监测法36 乳酸脱氢酶 血清 23-272-01 ,LD-L法,
第63页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
2B030-3152-037 凝血酶原时间 血浆 血浆凝固法 22-292-01 国际正常化PT2B030-3152-038 血浆 计算所得 比值 22-292-01 活化部分凝血2B020-3152-039 血浆 血浆凝固法 活酶时间 22-292-01
2B100-7180-040 纤维蛋白原 血浆 血浆凝固法 22-292-01
5D015-7080-0电化学发光41 甲胎蛋白 血清 23-051-01 法
5D010-7356-0电化学发光42 癌胚抗 原 血清 23-051-01 法
5D100-7770-0电化学发光43 糖类抗原12-5 血清 23-051-01 法
5D130-7775-0电化学发光44 糖类抗原19-9 血清 23-051-01 法
5D120-7748-0电化学发光45 糖类抗原15-3 血清 23-051-01 法 总前列腺特异5D305-7760-0电化学发光46 血清 抗原 23-051-51 法 游离前列腺特5D307-7760-0电化学发光47 血清 异抗原 23-051-52 法
5B023-7260-048 补体C3 血清 散射比浊法 23-061-01
5B024-7266-049 补体C4 血清 散射比浊法 23-061-01 超敏C反应蛋5C070-7086-050 血清 散射比浊法 白 23-061-53 免疫球蛋白5A015-7003-051 血清 散射比浊法 IgA 23-061-52
5A010-7002- 免疫球蛋白52 血清 散射比浊法 IgG
023-061-51 免疫球蛋白5A020-7004-053 血清 散射比浊法 IgM 23-061-53 抗链球菌溶血5E035-1352-054 血清 散射比浊法 素O 23-061-01
5G160-7020-055 类风湿因子 血清 散射比浊法 23-061-01
5F360-1430-056 丙肝病毒抗体 血清 电化学发光 23-051-01
第64页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
化学发光法
乙肝病毒表面5F016-8502-057 血清 抗原 23-051-01 电化学发光 法
乙肝病毒表面5F015-1430-058 血清 化学发光法 抗体 23-051-01
乙肝病毒e抗5F019-8508-059 血清 化学发光法 原 23-051-01
乙肝病毒e抗5F019-8508-060 血清 化学发光法 体 23-051-01
乙肝病毒核心5F015-1430-061 血清 化学发光法 抗体 23-051-04
抗人类免疫缺5F560-1430-0酶联免疫分62 血清 陷病毒抗体 23-023-04 析
化学发光法 抗梅毒螺旋体5E071-0000-063 血清 抗体 23-051-21
凝集法
梅毒血清学筛5E074-0000-0不加热血清64 血清 查实验TRUST 23-116-11 学实验
3H040-1352-065 磷 血清 磷钼酸法 23-272-01
尿酸酶-过氧 3C020-1352-066 尿酸 血清 化物酶偶联23-271-01 法
3F050-1352-067 总胆固 醇 血清 酶法 23-271-01
3F015-1352-068 甘油三 酯 血清 GPO-POD法 23-271-01
高密度脂蛋白3F070-1352-069 血清 匀相测定法 胆固醇 23-271-01
第65页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
低密度脂蛋白3F077-1352-070 血清 匀相测定法 胆固醇 23-271-01
3F180-7150-0免疫透射比71 载脂蛋白A1 血清 23-292-01 浊法
3F190-7154-0免疫透射比72 载脂蛋白B 血清 23-292-01 浊法
r,谷氨酰基3B090-1352-073 血清 连续监测法 转移酶 23-271-01
连续监测法
3B070-1352-074 碱性磷酸酶 血清 23-271-01 ,NPP底物
,AMP缓冲
液,
3A010-3152-0血浆 双缩脲法 22-291-01 75 总蛋白 3A010-1352-0血清 双缩脲法 23-271-01
3D010-1352-0葡萄糖氧化血浆 22-291-01 酶法 76 葡萄糖 3D010-1352-0电极葡萄糖血浆 22-261-01 氧化酶法
3J010-3152-0血浆 重氮法 22-291-01
77 胆红素 3J010-1352-0血清 重氮法 23-271-01
6A010-6003-0尿液 镜检法 03-704-11
6A010-6002-0粪便 镜检法 15-704-11
6A010-6004-0显微镜检查脑脊液 镜检法 78 41-704-11 (普通细菌)
6A010-6004-0胸水 镜检法 42-704-11
6A010-6004-0腹水 镜检法 43-704-11
第66页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
6A010-6004-0痰 镜检法 61-704-11
6A010-6004-0阴道分泌液 镜检法 67-704-11
显微镜检查78 (普通细菌)
6A010-6004-0脓 镜检法 86-704-11
6A010-6004-0咽喉分泌液 镜检法 63-704-11
6A205--6004-脑脊液 镜检法 041-716-11
6A205-6004-0胸水 镜检法 42-716-11
6A205-6004-0腹水 镜检法 43-716-11
显微镜检查79 ,分枝杆菌,
6A205-6001-0痰 镜检法 61-716-11
6A205-6001-0脓 镜检法 86-716-11
6A205-6001-0咽喉分泌液 镜检法 63-716-11
培养和鉴定6B010-6003-0常规培养~仪80 尿液 ,普通细菌, 03-741-11 器鉴定
第67页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌培养和鉴定6B010-6003-0常规培养~仪属、克雷80 尿液 ,普通细菌, 03-741-11 器鉴定 伯氏菌
属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单
胞菌属、
假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
第68页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、枸
橼酸杆菌
属、变形
杆菌属、
克雷伯氏培养和鉴定6B010-6004-0常规培养~仪菌属、沙80 全血 ,普通细菌, 18-741-11 器鉴定 雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
第69页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、枸
橼酸杆菌
属、变形
杆菌属、
克雷伯氏培养和鉴定6B010-6002-0常规培养~仪菌属、沙80 粪便 ,普通细菌, 15-741-11 器鉴定 雷氏菌
属、摩根
氏菌属、
普罗威登
斯菌属、
气单胞菌
属、假单
胞菌属、
不动杆菌
属、产碱
杆菌属、
黄杆菌属
第70页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌培养和鉴定6B010--6004-常规培养~仪属、克雷80 脑脊液 ,普通细菌, 041-744-11 器鉴定 伯氏菌
属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单
胞菌属、
假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
第71页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌培养和鉴定6B010--6004-常规培养~仪属、克雷80 胸水 ,普通细菌, 042-741-11 器鉴定 伯氏菌
属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单
胞菌属、
假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
第72页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌培养和鉴定6B010--6004-常规培养~仪属、克雷80 腹水 ,普通细菌, 043-741-11 器鉴定 伯氏菌
属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单
胞菌属、
假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
第73页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌培养和鉴定6B010-6001-0常规培养~仪属、克雷80 痰 ,普通细菌, 61-744-11 器鉴定 伯氏菌
属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单
胞菌属、
假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
第74页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌培养和鉴定6B010-6003-0常规培养~仪属、克雷80 阴道分泌液 ,普通细菌, 67-744-11 器鉴定 伯氏菌
属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单
胞菌属、
假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
第75页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
能力限
于:链球
菌属、肠
球菌属、
葡萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌
6B010-6005-0常规培养~仪属、克雷脓 86-741-11 器鉴定 伯氏菌
属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单培养和鉴定胞菌属、80 ,普通细菌, 假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
6B010-6001-0常规培养~仪能力限咽喉分泌液 63-744-11 器鉴定 于:
第76页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
链球菌
属、肠球
菌属、葡
萄球菌
属、肠杆
菌属、志
贺氏菌
属、沙门
氏菌属、
枸橼酸杆
菌属、变
形杆菌
属、克雷培养和鉴定6B010-6001-0常规培养~仪80 咽喉分泌液 伯氏菌,普通细菌, 63-744-11 器鉴定 属、沙雷
氏菌属、
摩根氏菌
属、普罗
威登斯菌
属、气单
胞菌属、
假单胞菌
属、不动
杆菌属、
产碱杆菌
属、黄杆
菌属
6B090-6004-0常规培养~仪全血 18-744-11 器鉴定
脑
6B090-6004-0常规培养~仪81 流感嗜血杆菌 脊 41-744-11 器鉴定
液
6B090-6004-0常规培养~仪痰 61-744-11 器鉴定
第77页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
6B075-6004-0常规培养~仪全血 18-744-11 器鉴定
肺炎链球菌培6B075-6004-0常规培养~仪82. 脑脊液 养和鉴定 41-744-11 器鉴定
6B075-6004-0常规培养~仪痰 61-744-11 器鉴定
药敏试验,普6C010-8500-083 菌株 MIC法 通细菌, 80-763-11
第78页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明 AST-GP67包含药
物:氨苄青霉素、环丙沙
星、克林霉素、红霉素、庆大霉素、高浓度庆大、左氧氟沙星、利奈唑胺、莫西沙星、呋喃妥因、苯唑西
林、奎奴普汀/达福普汀、利福平、高浓度链霉素、四环素、替吉环素~复方新诺明、万古霉素,药敏试验,普6C010-8500-0AST-GN1383 菌株 MIC法 通细菌, 80-763-11 包含药
物:阿米卡星、氨苄西林、氨苄西林/舒巴坦、氨曲南、头孢唑林、头孢吡肟、头孢替坦、头孢他
啶、头孢曲松、环丙沙星、氨曲南、庆大霉素、亚胺培南、左氧氟沙星、呋喃妥因、哌拉西林/他唑巴
坦、妥布霉素、复方新诺
明。
第79页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
序号 检验项目 样品类型 领域代码 检验方法 说明
氨苄西
林、头孢
曲松、头
孢唑啉、
环丙沙
星、克林药敏试验,普6C010-8500-083 菌株 K-B法 霉素、红通细菌, 80-763-11 霉素、庆
大霉素、
苯唑西
林、青霉
素、四环
素
能力限
于: 仪器鉴定 沙门氏菌
6B820-0000-0属 粪便 80-121-11 能力限
于: 血清学分型 沙门氏菌沙门菌培养和属 84. 鉴定 能力限
于: 仪器鉴定 沙门氏菌
6B820-0000-0属 全血 18-121-11 能力限
于: 血清学鉴定 沙门氏菌
属
能力限
于: 仪器鉴定 志贺氏菌
6B825-0000-0属 粪便 80-121-11 能力限
于: 血清学分型 志贺氏菌志贺菌培养和属 85. 能力限鉴定
于: 仪器鉴定 志贺氏菌
6B825-0000-0属 全血 能力限18-121-11
于: 血清学分型 志贺氏菌
属
第80页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT
APPENDIX OF LABORATORY ACCREDITATION CERTIFICATE
(Registration No. CNAS MT0046)
NAME:Department of Laboratory Medicine, Tongji Hospital of
Shanghai
ADDRESS:No.389, Xincun Road, Putuo District, Shanghai, China Accreditation Criteria: ISO 15189:2007 and relevant requirements of CNAS
Date of Issue:2012-12-21 Date of Expiry:2015-12-20 Date of Update:2014-02-07
APPENDIX 2 ACCREDITED EXAMINATION
Examination Analytical ? Sample Type Code Notes Item Method
Color 1A030-1351- 1 gravity urine reflection 003-291-01 test method
Color 1A010-1351- 2 protein urine reflection 003-291-01 test method
Color 1A020-1351- 3 glucose urine reflection 003-291-01 test method
Color 1A080-1351- 4 nitrite urine reflection 003-291-01 test method
Color 1A050-1351- 5 bilirubin urine reflection 003-291-01 test method
第81页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Color 1A040-1351- 6 Urobilinogen urine reflection 003-291-01 test method
Color 1A035-1351- 7 PH urine reflection 003-291-01 test method
Color 1A060-1351- 8 ketones urine reflection 003-291-01 test method
Color Leukocytes 1A075-1351- 9 urine reflection (test paper) 003-291-01 test method
Color occult blood 1A100-1351- 10 urine reflection reaction 003-291-01 test method
Flow Cytometry Quantitative 1A105-7682-011 urine leukocyte 03-282-01 Microscopy
imaging
techniques
1A105-7686-0Flow Quantitative 03-282-01 Cytometry 12 urinary red urine
1A Microscopy blood cells
1A105-7686-0imaging
03-701-01 techniques
1A105-1352-0Flow 03-282-01 Cytometry quantitative
13 Epithelial urine
Microscopy cells 1A105-1352-0 imaging 03-701-01 techniques
1A105-1352-0Flow 03-282-01 Cytometry quantitative 14 urine cast Microscopy 1A105-1352-0imaging 03-701-01 techniques
第82页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
fluorescence 2A010-7682-015 leukocytes whole blood staining flow 19-301-01 cytometry,
fluorescence Leukocyte 2A160-7682- 16 whole blood staining flow count 019- 301- 01 cytometry,
electrical
2A020-7686-0impedance 17 erythrocytes whole blood 19-301-01 Flow
Cytometry
electrical
2A050-7684-0impedance 18 platelets whole blood 19-301-01 Flow
Cytometry
2A030-1352-019 hemoglobin whole blood Colorimetry 19-301-01
2A040-1352-0electrical 20 hematocrit whole blood 19-301-01 impedance erythrocyte
mean 2A060-1352-021 whole blood Calculated corpuscular 19-301-01
volume
erythrocyte
mean 2A070-1352-022 whole blood Calculated corpuscular 19-301-01
hemoglobin
erythrocyte
mean 2A080-1352-023 corpuscular whole blood Calculated 19-301-01 hemoglobin
concentration
Blood cell 2A070-1352-0Optical 24 whole blood morphology 19-301-01 method
Electrode 3H015-1352-0plasma potential 22-261-01 method 25 potassium
Indirect 3H015-1352-0serum potentiometr23-261-01 ic method
第83页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Electrode 3H010-1352-0plasma potential 22-261-01 method 26 sodium
Indirect 3H010-1352-0serum potentiometr23-261-01 ic method
Electrode 3H020-1352-0plasma potential 22-261-01 method 27 chloride
Indirect 3H020-1352-0serum potentiometr23-261-01 ic method
3H030-1352-0plasma Colorimetry 22-291-01
28 Calcium
Indirect 3H030-1352-0serum potentiometr23-261-01 ic method
Enzyme 3C025-1352-0plasma conductivity 22-291-01 method 29 urea nitrogen
Enzyme 3C025-1352-0serum conductivity 23-264-01 method
3C015-1352-0plasma Colorimetry 22-291-01 30 creatinine
3C015-1352-0Picric acid serum 23-271-01 method
3A015-7052-0Bromocresol plasma 22-291-01 purple method 31 albumin
3A015-7052-0Bromocresol serum 23-271-01 purple method
3B045-3152-0velocity plasma 22-291-01 method alanine
32 aminotransfera
Continuous se 3B045-1352-0serum monitoring 23-272-01 method
asparate 3B035-3152-0velocity 33 aminotransferaplasma 22-291-01 method se
第84页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
asparate Continuous 3B035-1352-033 aminotransferaserum monitoring 23-272-01 se method
3B160-3152-0velocity 34 amylase plasma 22-291-01 method
3B010-3152-0velocity plasma 22-291-01 method creatine 35 kinase Continuous 3B010-1352-0serum monitoring 23-272-01 method
3B050-3152-0velocity plasma 22-291-01 method
lactate 36 Continuous dehydrogenase
3B050-1352-0monitoring serum 23-272-01 method(LD-L
method)
Plasma prothrombin 2B030-3152-037 plasma coagulation time 22-292-01 method
International 2B030-3152-038 plasma Calculated Normalized 22-292-01 Ratio
activated Plasma partial 2B020-3152-039 plasma coagulation thromboplastin 22-292-01 method time
Plasma 2B100-7180-040 fibrinogen plasma coagulation 22-292-01 method
Alpha- 5D015-7080- 41 serum ECL fetoprotein 023-051-01
Carcinoembry-o5D010-7356- 42 serum ECL nic antigen 023-051-01
Carbohydrate 5D100-7770- 43 serum ECL antigen 12-5 023-051-01
第85页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Carbohydrate 5D130-7775- 44 serum ECL antigen 19-9 023-051-01
Carbohydrate 5D120-7748- 45 serum ECL antigen 15-3 023-051-01
Total prostate Item 5D305-7760-046 specific serum ECL expansio23-051-51 antigen n Free prostate Item 5D307-7760-047 specific serum ECL expansio23-051-52 antigen n
Annex 46
of the 5B023-7260- 48 Complement-3 serum Nephelometry original 023-061-01 certific
ate
Annex
47of the 5B024-7266- 49 Complement-4 serum Nephelometry original 023-061-01 certific
ate
Annex 48
of the C-Reactive 5C070-7086- 50 serum Nephelometry original Protein 023-061-53 certific
ate
Annex 49
of the Immunoglo 5A015-7003- 51 serum Nephelometry original bulin A 023-061-52 certific
ate
Annex 50
of the Immunoglo 5A010-7002- 52 serum Nephelometry original bulin G 023-061-51 certific
ate
Annex 51
of the Immunoglo 5A020-7004- 53 serum Nephelometry original bulin M 023-061-53 certific
ate
Item Anti-streptoly5E035-1352-054 serum Nephelometry expansiosin O 23-061-01 n
第86页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Item Rheumatoid 5G160-7020-055 serum Nephelometry expansioFactor 23-061-01 n
Annex 52
of the hepatitis C 5F360-1430- 56 serum ECL original virus antibody 023-051-21 certific
ate
Annex 53
of the chemiluminesoriginal cence certificHepatitis B ate 5F016-8502- 57 virus surface serum 023-051-01 Annex 53 antigen of the
ECL original
certific
ate
Annex 54 Hepatitis B of the 5F015-1430- chemilumines58 surface serum original 023-051-01 cence antibody certific
ate
Annex 55
of the Hepatitis B e 5F019-8508- chemilumines59 serum original antigen 023-051-01 cence certific
ate
Annex 56
of the hepatitis B e 5F019-8508- chemilumines60 serum original antibody 023-051-01 cence certific
ate
Annex
57of the hepatitis B 5F015-1430- chemilumines61 serum original core antibody 023-051-04 cence certific
ate
Annex 58
of the anti-HIV 5F560-1430- 62 serum ELISA original antibody tests 023-023-04 certific
ate
第87页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex chemiluminesAnti-Treponema 59of the cence 5E071-0000- 63 pallidum serum original 023-051-21 antibody certific
ate agglutinatio
n
Annex Serological 60of the screening 5E074-0000- 64 serum Serum TEST original tests for 023-116-11 certificsyphilis ate
Annex
61of the inorganic 3H040-1352-0Phosphomolyb65 serum original phosphate 23-272-01 date method certific
ate
Annex
Uricase - 62of the 3C020-1352-066 uric acid serum peroxidase-coriginal 23-271-01 oupled method certific
ate
Annex
63of the Enzyme total 3F050-1352-0original 67 serum conductivity cholesterol 23-271-01 certificmethod ate
Change
Annex 64
of the
3F015-1352-0GOD-PAP original 68 triglyceride serum 23-271-01 method certific
ate
Change
Annex
65of the HDL-cholestero3F070-1352-0Homogeneous 69 serum original l 23-271-01 assay certific
ate
Annex
66of the LDL-cholestero3F077-1352-0Homogeneous 70 serum original l 23-271-01 assay certific
ate
第88页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
Immune 67of the apolipoprotein 3F180-7150-071 serum transmission original A-1 23-292-01 turbidity certific
ate
Annex
Immune 68of the apolipoprotein 3F190-7154-072 serum transmission original B 23-292-01 turbidity certific
ate
Annex
69of the Continuous gamma glutamy1 3B090-1352-0original 73 serum monitoring transpeptidase 23-271-01 certificmethod ate
Change
Annex
70of the Continuous alkaline 3B070-1352-0original 74 serum monitoring phosphatase 23-271-01 certificmethod ate
Change
3A010-3152- plasma Biuret method 022-291-01 75 protein
3A010-1352- serum Biuret method 023-271-01
3D010-1352- glucose plasma 022-291-01 oxidase
76 glucose
Electrode - 3D010-1352- plasma glucose 022-261-01 oxidase
3J010-3152- plasma Diazo method 022-291-01 77 bilirubin
3J010-1352- serum Diazo method 023-271-01
Annex microscopic 71of the examination 6A010-6003-0Microscopic 78 urine original (common 03-704-11 examination certificbacteria) ate
第89页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
71of the 6A010-6002-0Microscopic stool original 15-704-11 examination certific
ate
Annex
71of the cerebros 6A010-6004-0Microscopic original pinal fluid 41-704-11 examination certific
ate
Annex
71of the pleural 6A010-6004-0Microscopic original diffusion 42-704-11 examination certific
ate
Annex
71of the 6A010-6004-0Microscopic Ascites original 43-704-11 examination certificmicroscopic
ate examination 78 (common Annex bacteria) 71of the 6A010-6004-0Microscopic sputum original 61-704-11 examination certific
ate
Annex
71of the vaginal 6A010-6004-0Microscopic original secretion 67-704-11 examination certific
ate
Annex
71of the 6A010-6004-0Microscopic pus original 86-704-11 examination certific
ate
Annex
71of the pharyngeal 6A010-6004-0Microscopic original secretion 63-704-11 examination certific
ate
Annex microscopic 72of the 6A205-6003-0Microscopic 79 examination urine original 03-716-11 examination (mycobacteria) certific
ate
第90页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
72of the 6A205-6002-0Microscopic stool original 15-716-11 examination certific
ate
Annex
72of the cerebros 6A205--6004-Microscopic original pinal fluid 041-716-11 examination certific
ate
Annex
72of the pleural 6A205-6004-0Microscopic original diffusion 42-716-11 examination certific
ate
Annex microscopic 72of the 6A205-6004-0Microscopic 79 examination Ascites original 43-716-11 examination (mycobacteria) certific
ate
Annex
72of the 6A205-6001-0Microscopic sputum original 61-716-11 examination certific
ate
Annex
72of the 6A205-6001-0Microscopic pus original 86-716-11 examination certific
ate
Annex
72of the pharyngeal 6A205-6001-0Microscopic original secretion 63-716-11 examination certific
ate
第91页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity is
limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
Conventional Salmonelculture and training, la, identification6B010-6003- 80 urine instrument genus (common 003-741-11 identificatiCitrobacbacteria) on ter,
Proteus, Klebsiella,
Serratia,
Morgan'sgenus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第92页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
genus Conventional culture and Citrobactraining, identification6B010-6004-0ter, 80 Whole blood instrument (common 18-741-11 Proteus, identificatibacteria) Klebsielon la,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第93页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity limited
to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
genus Conventional culture and Citrobactraining, identification6B010-6002-0ter, 80 Stool instrument (common 15-741-11 Proteus, identificatibacteria) Klebsielon la,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第94页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identificationcerebrospina6B010--6004-genus 80 instrument (common l fluid 041-744-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第95页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identificationPleural 6B010--6004-genus 80 instrument (common diffusion 042-741-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第96页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identification6B010--6004-genus 80 Ascites instrument (common 043-741-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第97页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identification6B010-6001-0genus 80 sputum instrument (common 61-744-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia
,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第98页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the
original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identificationvaginal 6B010-6003-0genus 80 instrument (common secretion 67-742-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第99页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the original certificate
Capacity limited to:
Streptococcus, Enterococcus,
Staphylococcus, Enterobacter,
Shigella,
SalmonelConventional culture and la, training, identification6B010-6005-0genus 80 pus instrument (common 86-742-11 Citrobacidentificatibacteria) ter, on Proteus, Klebsiella,
Serratia,
Morgan's genus, Providence spp, Aeromonas,
Pseudomonas,
Acinetobacter, Alcaligenes,
Flavobacterium
第100页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
73of the
original
certific
ate
Capacity
limited
to:
Streptoc
occus,
Enteroco
ccus,
Staphylo
coccus,
Enteroba
cter,
Shigella
,
SalmonelConventional culture and la, training, identificationpharyngeal 6B010-6001-0genus 80 instrument (common secretion 63-744-11 Citrobacidentificatibacteria) ter, on Proteus,
Klebsiel
la,
Serratia
,
Morgan's
genus,
Providen
ce spp,
Aeromona
s,
Pseudomo
nas,
Acinetob
acter,
Alcalige
nes,
Flavobac
terium
Conventional Annex training, 74of the 6B090-6004-081 Haemophilus whole blood instrument original 18-744-11 identificaticertificon ate
第101页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Conventional Annex
training, 74of the cerebros 6B090-6004-0instrument original pinal fluid 41-744-11 identificaticertific
on ate 81 Haemophilus
Conventional Annex
training, 74of the 6B090-6004-0sputum instrument original 61-744-11 identificaticertific
on ate
Conventional Annex
training, 75of the 6B075-6004-0Whole blood instrument original 18-744-11 identificaticertific
on ate
Conventional Annex
training, 75of the Streptococcus cerebrospina6B075-6004-082 instrument original Pneumoniae l fluid 41-744-11 identificaticertific
on ate
Conventional Annex
training, 75of the 6B075-6004-0sputum instrument original 61-744-11 identificaticertific
on ate
第102页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Annex
76of the original certificate A Containing
drugs: amikacin,
ampicillin,
ampicillin /
sulbactam,
aztreonam,
cefazolin,
cefepime,
cefotetadrug n,
susceptibility Bacteria 6C010-8500-0ceftazid83 MIC method ime, test(Common Strains 80-763-11
ceftriaxbacteria) one,
ciprofloxacin, aztreonam,
celebrate big
vancomycin,
imipenem,
levofloxacin,
nitrofurantoin, piperacillin / tazobactam,
tobramycin,
co-trimoxazole.
第103页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
amikacin
,
ampicill
in,
ampicill
in /
sulbacta
m,
aztreonadrug m,
susceptibility Bacteria 6C010-8500-0cefazoli83 K-B method test(Common Strains 80-763-11 n,
bacteria) cefepime
,
cefoteta
n,
ceftazid
ime,
ceftriax
one,
ciproflo
xacin,
Capacity
Instrument limited
identificatito:
on Salmonel
la 6B820-0000-0stool 80-121-11 Capacity
limited
Serological to:
SalmonelCulture and la 84 identificationCapacity (Salmonella) Instrument limited
identificatito:
on Salmonel
la 6B820-0000-0whole blood 18-121-11 Capacity
limited
Serological to:
Salmonel
la
Capacity culture and Instrument 6B825-0000-0limited 85 identificationstool identificati80-121-11 to:Shige(Shigella) on lla
第104页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
Examination Analytical ? Sample Type Code Notes Item Method
Capacity
6B825-0000-0limited stool Serological 80-121-11 to:Shige
lla
Capacity culture and Instrument limited 85 identificationidentificatito:Shige(Shigella) on lla
6B825-0000-0whole blood 18-121-11
Capacity
limited Serological to:Shige
lla
第105页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese
version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.
ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1
第106页 共106页 No. CNAS MT0046
Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.