DIN EN ISO 7864-2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864 2016) German version EN ISO 7864 2016《一次性使用无菌皮下注射器 要求和试验方法(ISO 7864-2016) 德.pdf

1、December 2016 English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.25!%y“2595786www.din.deD

2、IN EN ISO 7864Sterile hypodermic needles for single use Requirements and test methods (ISO 7864:2016);English version EN ISO 7864:2016,English translation of DIN EN ISO 7864:2016-12Sterile Injektionskanlen fr den Einmalgebrauch Anforderungen und Prfverfahren (ISO 7864:2016);Englische Fassung EN ISO

3、7864:2016,Englische bersetzung von DIN EN ISO 7864:2016-12Aiguilles hypodermiques striles, non rutilisables Exigences et mthodes dessai (ISO 7864:2016);Version anglaise EN ISO 7864:2016,Traduction anglaise de DIN EN ISO 7864:2016-12SupersedesDIN EN ISO 7864:199601www.beuth.deDocument comprises 36 pa

4、gesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.11.16 DIN EN ISO 7864:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 7864:2016) has been prepared by Technical Committee ISO/TC 84 “Devices

5、 for administration of medicinal products and catheters” (Secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Co

6、mmittee Medicine), Working Committee NA 063-02-01 AA Injektionssysteme. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 7000 DIN ISO 7000 ISO 8362-1 DIN EN ISO 8362-1 ISO 8362-2 DIN EN ISO 8362-2 ISO 8362-3 DIN EN ISO 8362-3 ISO 8362-4

7、DIN EN ISO 8362-4 ISO 8362-5 DIN EN ISO 8362-5 ISO 8362-6 DIN EN ISO 8362-6 ISO 8362-7 DIN EN ISO 8362-7 ISO 8537 DIN EN ISO 8537 ISO 8871 (all parts) DIN EN ISO 8871 (all parts) ISO 80369-7 DIN EN ISO/IEC 80369-7 ISO 80369-20 DIN EN ISO 80369-20 Amendments This standard differs from DIN EN ISO 7864

8、:1996-01 as follows: a) the range of gauges has been expanded; b) a tapered needle designation has been introduced; c) reference has been made to the new ISO 80369 series of standards; d) a new informative annex on penetration force has been added; e) Annex B on fragmentation has been modified; f) i

9、nformative Annex C for symbol “do-not-reuse” has been dropped and a normative reference to ISO 15223-1 has been added; g) a new informative annex on flow rate has been added; h) a new informative annex on needle bonding strength has been added; i) reference has been made to ISO 23908 on sharps injur

10、y protection. DIN EN ISO 7864:2016-12 3 Previous editions DIN 13097-2: 1979-11 DIN 13097-3: 1979-11 DIN 13097-1: 1980-01 DIN EN ISO 7864: 1996-01 DIN EN ISO 7864:2016-12 4 National Annex NA (informative) Bibliography DIN EN ISO 8362-1, Injection containers and accessories Part 1: Injection vials mad

11、e of glass tubing DIN EN ISO 8362-2, Injection containers and accessories Part 2: Closures for injection vials DIN EN ISO 8362-3, Injection containers for injectables and accessories Part 3: Aluminium caps for injection vials DIN EN ISO 8362-4, Injection containers and accessories Part 4: Injection

12、vials made of moulded glass DIN EN ISO 8362-5, Injection containers and accessories Part 5: Freeze drying closures for injection vials DIN EN ISO 8362-6, Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials DIN EN ISO 8362-7, Injection contain

13、ers and accessories Part 7: Injections caps made of aluminium-plastics combinations without overlapping plastics parts DIN EN ISO 8537, Sterile single-use syringes, with or without needle, for insulin DIN EN ISO 8871 (all parts), Elastomeric parts for parenterals and for devices for pharmaceutical u

14、se DIN EN ISO/IEC 80369-7, Small bore connectors for liquids and gases in healthcare applications Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications DIN EN ISO 80369-20, Small bore connectors for liquids and gases in healthcare applications Part 20: Common test meth

15、ods DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7864 August 2016 ICS 11.040.25 Supersedes EN ISO 7864:1995English Version Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) Aig

16、uilles hypodermiques striles, non rutilisables - Exigences et mthodes dessai (ISO 7864:2016) Sterile Injektionskanlen fr den Einmalgebrauch - Anforderungen und Prfverfahren (ISO 7864:2016) This European Standard was approved by CEN on 15 July 2016. CEN members are bound to comply with the CEN/CENELE

17、C 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 CEN-CENELEC Management Centre or

18、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 Management Centre has the same status as the offic

19、ial 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, Lithuania, Luxembourg, Malta, Netherlands,

20、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 17, B-1000 Brussels 2016 CEN All rights of ex

21、ploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7864:2016 EForeword 7Introduction . 81 Scope . 92 Normative references 93 Terms and definitions . 94 Requirements .104.1 General 104.2 Statistics and reproducibility of test methods 104.3 Cleanliness

22、 .104.4 Limits for acidity or alkalinity 104.5 Limits for extractable metals .104.6 Size designation 114.6.1 Tubular needle designation .114.6.2 Tapered needle designation 114.7 Colour coding 124.8 Needle hub .124.8.1 Conical fitting .124.8.2 Colour of hub 124.9 Needle cap 124.10 Needle tube .134.10

23、.1 General.134.10.2 Tolerances on length134.10.3 Freedom from defects.144.10.4 Lubricant .144.11 Needle point .144.12 Bond between hub and needle tube 154.13 Patency of lumen 164.14 Sharps injury protection 174.15 Sterility and biocompatibility .174.15.1 Sterility 174.15.2 Biocompatibility 175 Packa

24、ging 175.1 Unit packaging 175.2 User packaging . 186 Information supplied by the manufacturer 186.1 General 186.2 Unit packaging 186.3 User packaging . 186.4 Storage container . 196.5 Transport wrapping 20Annex A (normative) Method for preparation of extracts 21Annex B (informative) Fragmentation te

25、st for medical needles 22Annex C (informative) Determination of flow rate through the needle 23Annex D (informative) Test method for measuring the penetration force and drag force for needles26Annex E (informative) Needle bonding strength test method 30Bibliography .32Contents PageAnnex ZA (informat

26、ive) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC OJ L 169 aimed to be coveredEuropean foreword .3.52EN ISO 7864:2016 (E) DIN EN ISO 7864:2016-12 European foreword This document (EN ISO 7864:2016) has been prepared by Technical Committee ISO/TC

27、 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 European Standard shall be given the status of a national stand

28、ard, 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 the elements of this document may be the subject of patent right

29、s. 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 the European Free Trade Association, and supports essential requir

30、ements 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 undated references, the latest edition of the referenced document (in

31、cluding 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 superseded and that its relevant contents can still be considered the ge

32、nerally 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 IEC standard, as listed in Table 1. NOTE The way in which these

33、references documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. 3EN ISO 7864:2016 (E) DIN EN ISO 7864:2016-12 Table 1 Correlations between undated normative references and dated EN and ISO standards Normative references as listed in Clause 2

34、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 6009:2016 ISO 8601 - ISO 8601: 2004 ISO 9626 EN ISO 9626:1995/A

35、1:2001 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 15223-1:2012 According to the CEN-CENELEC Internal Regulati

36、ons, 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, Germany, Greece, Hungary, Iceland, Ireland, Italy

37、, 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 EN ISO 7864:2016 without any modification. 4EN ISO 7864:2016

38、 (E) DIN EN ISO 7864:2016-12 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 standardization request M/295 concerning the development

39、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 Official Journal of the European Union under that Directive,

40、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 regulations. NOTE 1 Where a reference from a clause of

41、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 lowest possible level, minimized or removed, according to t

42、he 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 based on normative references according to the table of re

43、ferences 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 this European Standard and Annex I of Directive 93/42/EEC O

44、J 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 explicitly covered. 7.6 4.8.1 8.1 4.14, 5 The part of ER 8.1

45、 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 5EN ISO 7864:2016 (E) DIN EN ISO 7864:2016-12 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), 6.4(a) 13.3 (c) 6.2(b), 6.3(b), 6.4(c) 13.3(d) 6.2(c)

46、, 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 published in the Official Journal of the European Union.

47、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. 6EN ISO 7864:2016 (E) DIN EN ISO 7864:2016-12 ForewordISO (the Inte

48、rnational 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

49、 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.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC