BS EN ISO 4074-2015 Natural rubber latex male condoms Requirements and test methods《天然橡胶乳胶避孕套 要求和试验方法》.pdf

1、BSI Standards PublicationBS EN ISO 4074:2015Natural rubber latex malecondoms Requirements and test methodsBS EN ISO 4074:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 4074:2015.It supersedes BS EN ISO 4074:2002 which will be withdrawn on 11November 20

2、17.The UK participation in its preparation was entrusted to Technical Committee CH/157, Mechanical contraceptives.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract.

3、 Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 88301 9 ICS 11.200 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authorit

4、y of the Standards Policy and Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 4074 November 2015 ICS 11.200 Supersedes EN ISO 4074:2002English Version Natural rubber latex male condoms - R

5、equirements and test methods (ISO 4074:2015) Prservatifs masculins en latex de caoutchouc naturel -Exigences et mthodes dessai (ISO 4074:2015) Kondome aus Naturkautschuklatex - Anforderungen und Prfverfahren (ISO 4074:2015) This European Standard was approved by CEN on 16 July 2015. CEN members are

6、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 th

7、e 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 Management Cent

8、re 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, Lithuani

9、a, 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 17, B-1000

10、 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 4074:2015 EBS EN ISO 4074:2015EN ISO 4074:2015 (E) 3 European foreword This document (EN ISO 4074:2015) has been prepared by Technical Committee ISO/TC 157 “Non-sys

11、temic contraceptives and STI barrier prophylactics“ 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 standard, either by publication of an identical text or by end

12、orsement, at the latest by May 2016, and conflicting national standards shall be withdrawn at the latest by November 2017. 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 identi

13、fying any or all such patent rights. This document supersedes EN ISO 4074:2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(

14、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 (including any amendments) applies. For dated references, only th

15、e 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 generally acknowledged state-of-art. When an IEC or ISO standard

16、 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 version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirem

17、ents determines the extent (in whole or in part) to which they apply. BS EN ISO 4074:2015EN ISO 4074:2015 (E) 4 Table 1 Correlation between normative references and dated EN and ISO or IEC standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IE

18、C ISO 2859-1 - ISO 2859-1:1999 + Cor1:2001 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009 ISO 10993-10 EN ISO 10993-1:2013 ISO 10993-1:2010 ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012 ISO 15223-2 - ISO 15223-2:2010 ISO/IEC 17025 EN ISO/IEC 1702

19、5:2005 ISO/IEC 17025:2005 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

20、 of Macedonia, 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 4074:2015 has been approve

21、d by CEN as EN ISO 4074:2015 without any modification. BS EN ISO 4074:2015EN ISO 4074:2015 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate giv

22、en to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Medical Devices Directive 93/42/EEC. Once this standard is cited in the Official Journal of the European Union under that Directive and has be

23、en implemented as a national standard in at least one Member State, 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 ass

24、ociated EFTA regulations. Table ZA.1 Correspondence between this European Standard and the Essential Requirements of EU Directive 93/42/EEC as amended for medical devices Clause(s)/sub-clause(s) of this European Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes

25、 6, 7, 14, 15 7.2 Clauses 6, 7, 14 and 15 provide a presumption of conformity with the Essential Requirements relating to the risk posed by contaminants and residues to persons involved in the transport, storage and use of the devices. 6, 15.2.4.2 7.3 Clause 15.2.4.2 includes requirements for inform

26、ation to users regarding use of additional lubricants with condoms. 6, 15.2.4.2 7.4 This standard does not consider the systemic safety and usefulness of any ancillary medicinal substance that could be incorporated into the condom. 6 7.5 7 8.1 Condoms are not sterile devices but manufacturers should

27、 take steps to control microbial contamination. 14, 15.1 8.6 15.2 13.1 15.2.2,15.2.4.1, 15.2.4.2, 13.2 15.2.3, 15.2.4.1, 15.2.4.2, 15.2.5 13.3 15.2.4.1, 15.2.4.2 13.4 15.2.3, 15.2.4.1 13.5 BS EN ISO 4074:2015EN ISO 4074:2015 (E) 6 15.2.4.2, 15.2.5 13.6 Annexes, which provide details of test methods,

28、 have not been included as the all the requirements are included above. WARNING Other requirements and other EU Directives may be applicable to the products falling within the scope of this European Standard. BS EN ISO 4074:2015ISO 4074:2015(E)Foreword vIntroduction vii1 Scope . 12 Normative referen

29、ces 13 Terms and definitions . 14 Quality verification 35 Lot size 36 Biocompatibility . 47 Microbial contamination 48 Product claims 49 Design 49.1 Integral bead . 49.2 Lubrication . 49.3 Dimensions . 59.3.1 Length 59.3.2 Width . 59.3.3 Thickness 510 Bursting volume and pressure . 511 Stability and

30、 shelf life 611.1 General . 611.2 Minimum stability requirements 611.3 Procedure for determining shelf life by real-time stability studies 711.4 Estimating shelf life based upon accelerated stability studies 712 Freedom from holes 713 Visible defects 814 Package integrity of individual container 815

31、 Packaging and labelling 815.1 Packaging . 815.2 Labelling . 815.2.1 General 815.2.2 Symbols 815.2.3 Individual container 815.2.4 Consumer package . 915.2.5 Condoms not distributed in consumer packages .1115.3 Inspection . 1116 Test report 11Annex A (normative) Sampling plans intended for assessing

32、compliance of a continuing series of lots of sufficient number to allow the switching rules to be applied 12Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .14Annex C (normative) Determination of total lubricant for condoms in individual containers 16Annex D (

33、normative) Determination of length .20Annex E (normative) Determination of width .22Annex F (normative) Determination of thickness .23Annex G (informative) Determination of microbial contamination .26 ISO 2015 All rights reserved iiiContents PageBS EN ISO 4074:2015ISO 4074:2015(E)Annex H (normative)

34、 Determination of bursting volume and pressure 31Annex I (normative) Oven treatment for condoms 33Annex J (informative) Determination of force and elongation at break of test pieces of condoms .34Annex K (normative) Determination of shelf life by real-time stability studies .37Annex L (informative)

35、Guidance on conducting and analysing accelerated ageing studies 40Annex M (normative) Testing for holes 42Annex N (normative) Testing for package integrity 48Annex O (informative) Calibration of air inflation equipment for determination of bursting volume and pressure .50Annex P (informative) Recomm

36、endations for testing condoms that fall outside of the size ranges specified in ISO 4074 .54Bibliography .56iv ISO 2015 All rights reservedBS EN ISO 4074:2015ISO 4074:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO m

37、ember 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, governm

38、ental 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 maintenanc

39、e 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 rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention

40、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 identified during the development of the document will be in the Introduction and/

41、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 on the meaning of ISO specific terms and expressions related to conformity ass

42、essment, 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 ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics.This thi

43、rd edition cancels and replaces the second edition (ISO 4074:2014), which has been technically revised. The modifications are as follows:a) The maximum lot size has been limited to 500 000.b) Specific requirements for biocompatibility assessments, as defined in ISO 10993-1, have been added.c) It is

44、recommended that manufacturers establish procedures for the periodic monitoring of microbial contamination (bioburden) as part of their quality management system including requirements for the absence of specific pathogens and limits for total viable counts on finished condoms; methods of determinin

45、g bioburden levels on condoms are given in Annex G.d) Specific requirements for extra strength condoms have been deleted but there is now a general requirement for manufacturers to justify any additional claims made for their products; claims relating to improved efficacy or safety have to be substa

46、ntiated by clinical investigation.e) A minimum airburst volume of 28,0 dm3has been introduced for condoms with mid-body widths that are greater than or equal to 65,0 mm and not more than 75,0 mm.f) The radius of the inner edge of the clamping collar wherever it contacts the inflated condom has to be

47、 a minimum of 2 mm (Annex H).g) The volumes of electrolyte used in the electrical test for determining freedom from holes described in Annex M have been brought into line with the volumes used for the water leak test.h) The volumes of water or electrolyte specified in the freedom from holes test hav

48、e been increased for condoms that have mid-body widths greater than or equal to 56 mm and/or are longer that 210 mm.i) When conducting the electrical test for freedom from holes, the voltage is now measured from the time that the condom is first immersed and for up to 10 s after full immersion. ISO

49、2015 All rights reserved vBS EN ISO 4074:2015ISO 4074:2015(E)j) The method of testing for freedom from holes specified in ASTM D34928has been included by reference.k) A limit has been introduced for the number of individual containers with visibly open seals, to be evaluated when the containers are inspected during the freedom from holes test described in Annex M.l) Recommended requirements for minimum airburst properties and freedom from holes testing for condoms narrower than 45 mm and/or shorter than 160 mm have been introduced in informative Annex P