EN ISO 7864-2016 en Sterile hypodermic needles for single use - Requirements and test methods《一次性使用无菌注射针-要求和试验方法(ISO 7864 2016)》.pdf

1、BS EN ISO 7864:2016Sterile hypodermic needles forsingle use Requirements andtest methods (ISO 7864:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 7864:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 7864:

2、2016.It supersedes BS EN ISO 7864:1996 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to in

3、clude all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 85627 3ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This Bri

4、tish Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2016.Amendments/corrigenda issued since publicationDateT e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7864 August 2016 ICS 11.040.25 Supersedes EN ISO 7864:1

5、995English Version Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) Aiguilles hypodermiques striles, non rutilisables - Exigences et mthodes dessai (ISO 7864:2016) Sterile Injektionskanlen fr den Einmalgebrauch - Anforderungen und Prfverfahren (ISO 7864:2016)

6、 This European Standard was approved by CEN on 15 July 2016. 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 refer

7、ences concerning such national standards may be obtained on application 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

8、 member into its own language and notified to the CEN-CENELEC Management 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

9、, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCH

10、ES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7864:2016 EBS EN ISO 7864:2016EN ISO 7864:2016 (E) 3 European foreword This document (E

11、N ISO 7864:2016) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use“ in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This

12、 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 February 2017, and conflicting national standards shall be withdrawn at the latest by February 2017. Attention is drawn to the possibility that some of

13、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 7864:1995. This document has been prepared under a mandate given to CEN by the European Commission and th

14、e European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. The following referenced documents are indispensable for the application of this document. For undat

15、ed references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been supersed

16、ed and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated ISO or

17、IEC standard, as listed in Table 1. NOTE The way in which these references documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 7864:2016EN ISO 7864:2016 (E) 4 Table 1 Correlations between undated normative references and dated EN a

18、nd ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 594-1 EN 20594-1: 1993/AC: 1996/ A1: 1997 ISO 594-1:1986 ISO 594-2 EN 1707:1996 ISO 594-2:1998 ISO 3696 EN ISO 3696:1995 ISO 3696:1987 ISO 6009 EN ISO 6009:1994/AC:2008 ISO 600

19、9:2016 ISO 8601 - ISO 8601: 2004 ISO 9626 EN ISO 9626:1995/A1:2001 ISO 9626:2016 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 ISO 23908 EN ISO 23908:2013 ISO 23908:2011 ISO 80369-1 EN ISO 80369-1:2010 ISO 80369-1:2010 ISO 15223-1 EN ISO 15223-1:2012 ISO

20、 15223-1:2012 According 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 Macedoni

21、a, France, Germany, 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 7864:2016 has been approved by CEN as

22、EN ISO 7864:2016 without any modification. BS EN ISO 7864:2016EN ISO 7864:2016 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 aimed to be covered This European Standard has been prepared under a Commissions s

23、tandardization request M/295 concerning the development of European Standards related to medical devices to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 160. Once this standard is cited in the Offic

24、ial Journal of the European Union under that Directive, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA

25、 regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the low

26、est possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is ba

27、sed on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between thi

28、s European Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.1 4.9.1, 4.9.4, 4.14 7.3 4.4, 4.5, 4.9.1, 4.9.4, 4.14 7.5 4.4, 4.5, 4.9.1, 4.9.4, 4.14 The part of ER 7.5 related to phthalates is not expl

29、icitly covered. 7.6 4.8.1 8.1 4.14, 5 The part of ER 8.1 relating to easy handling is not addressed. 8.3 5 8.4 4.14.1, 5.1 9.1 4.8.1 9.2 4.6, 4. 9.3, 4.9.4, 4.10 BS EN ISO 7864:2016EN ISO 7864:2016 (E) 6 13.1 6.1 13.2 4.7, 4.8.2, 4.9, 6.2, 6.3 13.3(a) 6.2(e), 6.3(g), 6.4(e) 13.3(b) 6.2(a), 6.3(a), 6

30、.4(a) 13.3 (c) 6.2(b), 6.3(b), 6.4(c) 13.3(d) 6.2(c), 6.3(e),6.4(b) 13.3(e) 6.2 (f), 6.3(f), 6.4(d) 13.3 (f) 6.2(d), 6.3(c) 13.3(i) 6.3(h), 6.4(f) 13.3(k) 6.1, 6.3(d) WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained in the list publi

31、shed in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard. BS EN ISO 7864:

32、2016ISO 7864:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Statistics and reproducibility of test methods . 24.3 Cleanliness 24.4 Limits for acidity or alkalinity . 24.5 Limits for extractable metals 24.6 Size designa

33、tion . 34.6.1 Tubular needle designation 34.6.2 Tapered needle designation . 34.7 Colour coding . 44.8 Needle hub 44.8.1 Conical fitting 44.8.2 Colour of hub . 44.9 Needle cap . 44.10 Needle tube 54.10.1 General 54.10.2 Tolerances on length. 54.10.3 Freedom from defects 64.10.4 Lubricant 64.11 Needl

34、e point 64.12 Bond between hub and needle tube . 74.13 Patency of lumen . 84.14 Sharps injury protection . 94.15 Sterility and biocompatibility 94.15.1 Sterility . 94.15.2 Biocompatibility . 95 Packaging . 95.1 Unit packaging . 95.2 User packaging . 106 Information supplied by the manufacturer 106.1

35、 General 106.2 Unit packaging 106.3 User packaging . 106.4 Storage container . 116.5 Transport wrapping 12Annex A (normative) Method for preparation of extracts 13Annex B (informative) Fragmentation test for medical needles 14Annex C (informative) Determination of flow rate through the needle 16Anne

36、x D (informative) Test method for measuring the penetration force and drag force for needles18Annex E (informative) Needle bonding strength test method 22Bibliography .24 ISO 2016 All rights reserved iiiContents PageBS EN ISO 7864:2016ISO 7864:2016(E)ForewordISO (the International Organization for S

37、tandardization) 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 ri

38、ght 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.The procedure

39、s 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 the different types of ISO documents should be noted. This document was drafted in accordance with the editorial ru

40、les 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. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights ident

41、ified 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 document is information given for the convenience of users and does not constitute an endorsement.For an explanation o

42、n 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 Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is I

43、SO/TC 84, Devices for administration of medicinal products and catheters.In some countries, national regulations are legally binding and their requirements take precedence over the ones in this International Standard.This fourth edition cancels and replaces the third edition (ISO 7864:1993), which h

44、as been technically revised with the following changes:a) expansion of the range of gauges;b) introduction of tapered needle designation;c) reference to the new ISO 80369- series;d) new informative annex on penetration force;e) change in Annex B on fragmentation;f) deleted informative Annex C for sy

45、mbol for “do-not-reuse” and added normative reference toISO 15223-1;g) new informative annex on flow rate;h) new informative annex on needle bonding strength;i) reference to ISO 23908 on sharps injury protection.iv ISO 2016 All rights reservedBS EN ISO 7864:2016ISO 7864:2016(E)IntroductionThis Inter

46、national Standard covers sterile hypodermic needles for single use intended to inject or withdraw fluids from primarily the human body.Plastics materials to be used for the construction of needles are not specified, as their selection will depend to some extent upon the design, process of manufactur

47、e and method of sterilization employed by individual manufacturers.Hypodermic needles specified in this International Standard are intended for use with syringes having a 6 % Luer conical fitting as specified in ISO 80369-7 in conjunction with ISO 80369-1 and ISO 80369-20.Devices/connectors intended

48、 to mate with hypodermic needles of the standard, but which deviate from ISO 80369-7 shall provide demonstrated evidence of safe functional performance.Guidance on transition periods for implementing the requirements of this International Standard is given in ISO/TR 19244. ISO 2016 All rights reserv

49、ed vBS EN ISO 7864:2016BS EN ISO 7864:2016Sterile hypodermic needles for single use Requirements and test methods1 ScopeThis International Standard specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For da