EN ISO 8362-2-2015 en Injection containers and accessories - Part 2 Closures for injection vials《注射容器及配件 第5部分 冷冻干燥瓶塞注射瓶(ISO 8362-2 2015)》.pdf
《EN ISO 8362-2-2015 en Injection containers and accessories - Part 2 Closures for injection vials《注射容器及配件 第5部分 冷冻干燥瓶塞注射瓶(ISO 8362-2 2015)》.pdf》由会员分享,可在线阅读,更多相关《EN ISO 8362-2-2015 en Injection containers and accessories - Part 2 Closures for injection vials《注射容器及配件 第5部分 冷冻干燥瓶塞注射瓶(ISO 8362-2 2015)》.pdf(18页珍藏版)》请在麦多课文档分享上搜索。
1、BSI Standards PublicationBS EN ISO 8362-2:2015Injection containers andaccessoriesPart 2: Closures for injection vialsBS EN ISO 8362-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO8362-2:2015. It supersedes BS EN ISO 8362-2:2010 which is withdrawn.The
2、UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its
3、correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 86782 8ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Stra
4、tegy Committee on 31 October 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8362-2 October 2015 ICS 11.040.20 Supersedes EN ISO 8362-2:2010English Version Injection containers and accessories - Part 2: Closures
5、for injection vials (ISO 8362-2:2015) Rcipients et accessoires pour produits injectables - Partie 2 : Bouchons pour flacons (ISO 8362-2:2015) Injektionsbehltnisse und Zubehr - Teil 2: Stopfen fr Injektionsflaschen (ISO 8362-2:2015) This European Standard was approved by CEN on 29 August 2015. CEN me
6、mbers 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 applica
7、tion to the CEN-CENELEC 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 CEN-CENELEC Manag
8、ement Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia
9、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix
10、17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8362-2:2015 EBS EN ISO 8362-2:2015EN ISO 8362-2:2015 (E) 3 European foreword This document (EN ISO 8362-2:2015) has been prepared by Technical Committee I
11、SO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“. 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 April 2016, and conflicting national standards shall be
12、 withdrawn at the latest by April 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8362-2:2010. A
13、ccording to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germ
14、any, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8362-2:2015 has been approved by CEN as EN ISO 8362-2
15、:2015 without any modification. BS EN ISO 8362-2:2015ISO 8362-2:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Classification 14 Shape and dimensions 25 Designation 36 Material 37 Performance requirements . 47.1 General . 47.2 Physical requirements 47.2.1 Hardness . 47.2.2 Pene
16、trability 47.2.3 Fragmentation 47.2.4 Self-sealing and aqueous solution tightness test . 47.2.5 Dye solution tightness test 47.2.6 Resistance to ageing 47.3 Chemical requirements 47.4 Biological requirements 47.5 Particulate contamination requirements . 58 Labelling 5Bibliography 6 ISO 2015 All righ
17、ts reserved iiiContents PageBS EN ISO 8362-2:2015ISO 8362-2:2015(E)ForewordISO (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
18、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
19、the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for
20、 the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights
21、. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this
22、document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to T
23、rade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use.This third edition cancels and replaces the second edition (ISO 8362-
24、2:2008), which has been technically revised in order to include a new 7.5 particulate contamination requirements.ISO 8362 consists of the following parts, under the general title Injection containers and accessories: Part 1: Injection vials made of glass tubing Part 2: Closures for injection vials P
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