BS EN ISO 8536-2-2002 医用输液器具;输液瓶塞,

BRITISH STANDARD BS EN ISO 8536-2:2002 Incorporating Corrigendum No. 1 Infusion equipment for medical use — Part 2: Closures for infusion bottles The European Standard EN ISO 8536-2:2002 has the status of a British Standard ICS 11.040.20 ����������� � ��� � ������������������� ��������� ��� ���������� ��� Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS --``,`-`-`,,`,,`,`,,`--- BS EN ISO 8536-2:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 2 October 2002 © BSI 5 December 2002 ISBN 0 580 40494 3 National foreword This British Standard is the official English language version of EN ISO 8536-2:2002. It is identical with ISO 8536-2:2001. It supersedes BS EN ISO 8536-2:1999 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212, In vitro diagnostic systems, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. — aid enquirers to understand the text; — present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; — monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 10, the Annex ZA page and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14257 Corrigendum No. 1 5 December 2002 Replacing the EN ISO foreword page and the Annex ZA page Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS - - ` ` , ` - ` - ` , , ` , , ` , ` , , ` - - - EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 8536-2 September 2002 ICS 11.040.20 Supersedes EN ISO 8536-2:1999 English version Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2001) Matériel de perfusion à usage médical - Partie 2: Bouchons pour flacons de perfusion (ISO 8536-2:2001) Infusionsgeräte zur medizinischen Verwendung - Teil 2: Stopfen für Infusionsflaschen (ISO 8536-2:2001) This European Standard was approved by CEN on 30 August 2002. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T É E U R O P É E N D E N O R M A LI S A T I O N EUR OP ÄIS C HES KOM ITEE FÜR NOR M UNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2002 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-2:2002 E Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS --``,`-`-`,,`,,`,`,,`--- CORRECTED 2002-11-13 Foreword The text of ISO 8536-2:2001 has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 8536-2:2002 by the Technical Board of CEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2003, and conflicting national standards shall be withdrawn at the latest by March 2003. This document supersedes EN ISO 8536-2:1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8536-2:2001 has been approved by CEN as EN ISO 8536-2:2002 without any modifications. NOTE Normative references to International Standards are listed in annex ZA (normative). EN ISO 8536−2:2002 Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS - - ` ` , ` - ` - ` , , ` , , ` , ` , , ` - - - Reference number ISO 8536-2:2001(E) INTERNATIONAL STANDARD ISO 8536-2 Second edition 2001-06-15 Infusion equipment for medical use — Part 2: Closures for infusion bottles Matériel de perfusion à usage médical — Partie 2: Bouchons pour flacons de perfusion EN ISO 8536−2:2002 Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS --``,`-`-`,,`,,`,`,,`--- EN ISO 8536−2:2002 iiCopyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS --``,`-`-`,,`,,`,`,,`--- ISO -63582:(1002)E © ISO 1002 – All rights rsedevre iii Contents Page Foreword.....................................................................................................................................................................iv Introduction .................................................................................................................................................................v 1 Scope ..............................................................................................................................................................1 2 Normative references ....................................................................................................................................1 3 Dimensions and designation........................................................................................................................1 3.1 Dimensions.....................................................................................................................................................1 3.2 Designation ....................................................................................................................................................2 4 Material ...........................................................................................................................................................3 5 Physical requirements ..................................................................................................................................3 5.1 General............................................................................................................................................................3 5.2 Performance...................................................................................................................................................3 5.3 Hardness.........................................................................................................................................................3 5.4 Fragmentation ................................................................................................................................................3 5.5 Spike penetration force.................................................................................................................................3 5.6 Sealability and spike retention.....................................................................................................................4 5.7 Storage............................................................................................................................................................4 6 Chemical requirements .................................................................................................................................4 7 Biological requirements................................................................................................................................4 8 Sample ............................................................................................................................................................4 9 Marking ...........................................................................................................................................................4 10 Conformance..................................................................................................................................................4 Annex A (normative) Determination of fragments...................................................................................................5 Annex B (normative) Determination of spike penetration force ............................................................................7 Annex C (normative) Spike retention/sealability .....................................................................................................9 Annex D (normative) Closure piercing device .......................................................................................................10 EN ISO 8536−2:2002 iiiCopyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS --``,`-`-`,,`,,`,`,,`--- ISO -63582:(1002)E vi © ISO 1002 – All rights rsedevre Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 8536 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 8536-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 8536-2:1992), which has been technically revised. ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use: � Part 1: Infusion glass bottles � Part 2: Closures for infusion bottles � Part 3: Aluminium caps for infusion bottles � Part 4: Infusion sets for single use, gravity feed � Part 5: Burette-type infusion sets � Part 6: Freeze drying closures for infusion bottles � Part 7: Caps made of aluminium-plastics combinations for infusion bottles Annexes A, B, C and D form a normative part of this part of ISO 8536. EN ISO 8536−2:2002 ivCopyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS - - ` ` , ` - ` - ` , , ` , , ` , ` , , ` - - - ISO -63582:(1002)E © ISO 1002 – All rights rsedevre v Introduction The materials from which injection containers (including elastomeric closures) are made are suitable primary packaging materials for storing injectable products until they are administered. EN ISO 8536−2:2002 vCopyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS - - ` ` , ` - ` - ` , , ` , , ` , ` , , ` - - - Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS --``,`-`-`,,`,,`,`,,`--- INTENRATIONAL TSANDADR ISO -63582:(1002)E © ISO 1002 – All rights rsedevre 1 Infusion equipment for medical use — Part 2: Closures for infusion bottles 1 Scope This part of ISO 8536 specifies the design, dimensions, material, performance requirements and testing of closures for infusion bottles as specified in ISO 8536-1. Closures described herein are intended for single use only. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 8536. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 8536 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 48, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD). ISO 868, Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness). ISO 2230, Vulcanized rubber — Guide to storage. ISO 8536-1, Infusion equipment for medical use — Part 1: Infusion glass bottles. ISO 8536-3, Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles. ISO 8871-1:—1), Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates. 3 Dimensions and designation 3.1 Dimensions The dimensions of closures shall be as shown in Figure 1 and as given in Table 1. Figure 1 illustrates two typical designs of closures, type A and type B. 1) To be published. EN ISO 8536−2:2002 1Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS - - ` ` , ` - ` - ` , , ` , , ` , ` , , ` - - - ISO -63582:(1002)E 2 © ISO 1002 – All rights rsedevre Dimensions in millimetres Figure 1 — Dimensions and configuration of type A and type B closures Table 1 — Dimensions of infusion closures Dimensions in millimetres d1 d2 d3 d4 d5 d6 h1 h2 h3 h4a h5Type Nominal size � 0,2 max. min. min. max. � 0,3 � 0,4 � 0,3 � 0,3 A 32 23,6 18,2 13 13 14 30,8 12,2 4 5,1 4 — B 28 19,6 15,5 6,9 6,1 7,1 27,1 10,2 3,4 4,2 2,5 5,1 a Indentations may reduce the piercing thickness. 3.2 Designation Closures are designated according to type: the two types, A and B, are illustrated in Figure 1. The designation is expressed as the number of this part of ISO 8536 followed by the nominal size of the infusion bottle followed by the type letter. EN ISO 8536−2:2002 2Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS --``,`-`-`,,`,,`,`,,`--- ISO -63582:(1002)E © ISO 1002 – All rights rsedevre 3 EXAMPLE A type A closure for infusion bottles of nominal size 32 mm complying with the requirements laid down in this part of ISO 8536 is designated as follows: Infusion closure ISO 8536-2 - 32 - A 4 Material The closure shall be made of self-sealing elastomeric material and shall withstand sterilization by autoclaving in saturated steam at (121 � 2) �C for 1 h without impairment of its function under the conditions of normal use. 5 Physical requirements 5.1 General The physical test procedures, described in annexes A, B and C, serve exclusively as comparative type tests of different elastomeric materials and do not enable conclusions to be drawn on the serviceability of closures to be applied. The reason for this is that, in practice, a multitude of different plastic spikes are on the market which do not meet the requirements of the reference steel spike in annex D. 5.2 Performance 5.2.1 In order to facilitate the production process, the flange of the closure may have a slightly conical shape (max. 0,8 mm related to the diameter). The trimming edge of the flange shall comply with the acceptable tolerances specified for the diameter of the flange. 5.2.2 All edges of the closure may be rounded. 5.2.3 Sprues, bleeders and injection points shall not be present in the sealing area. 5.2.4 On the inside diameter, d3, there may be marks or indentations; on the outside, d4, there may be spacers, of which the height should not exceed 0,3 mm. 5.3 Hardness The hardness shall be agreed between manufacturer and user. The hardness shall not differ from the nominal value by more than � 5 IRHD when tested in accordance with ISO 48 or � 5 Shore A when tested in accordance with ISO 868. NOTE The manufacturer should provide suitable test plates upon request. 5.4 Fragmentation When tested for fragmentation in accordance with annex A, not more than 20 fragments of diameter equal to or greater than 50 �m per ten piercings shall be observed. 5.5 Spike penetration force When tested for penetrability in accordance with annex B, the force needed to penetrate the closure shall not exceed 80 N, and the average value shall be less than 75 N. No closure shall be pushed into the bottle during piercing. EN ISO 8536−2:2002 3Copyright European Committee for Standardization Provided by IHS under license with CEN Not for ResaleNo reproduction or networking permitted without license from IHS - - ` ` , ` - ` - ` , , ` , , ` , ` , , ` - - - ISO -63582:(1002)E 4 © ISO 1002 – All rights rsedevre 5.6 Sealability and spike retention When tested in accordance with annex C, complete penetration shall be achieved (no closure shall