BS EN ISO 4074-2002 Natural latex rubber condoms - Requirements and test methods《天然乳胶阴茎套 要求和试验方法》.pdf

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1、BRITISH STANDARD BS EN ISO 4074:2002 Incorporating Corrigenda May 2002, November 2003 and April 2008 Natural latex rubber condoms Requirements and test methods ICS 11.200 BS EN ISO 4074:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy a

2、nd Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 15 April 2002 BSI 2010 ISBN 978 0 580 62892 4 National foreword This British Standard is the UK implementation of EN ISO 4074:2002. It is identical with ISO 4074:2002, incorporating corrigenda

3、September 2004 and April 2008. It supersedes BS EN 600:1996, which is withdrawn. indicated in the text by indicated in the text by . Text altered by ISO corrigendum April 2008 is in the text by tags. Text altered by ISO corrigendum September 2004 is The start and finish of text introduced or altered

4、 by corrigendum is indicated The UK participation in its preparation was entrusted to Technical Committee CH/30, 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 necess

5、ary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments corrigenda issued since publication Amd. No. Date Comments 13919 Corrigendum No. 1 13 May 2002 Correction to the EN ISO forewo

6、rd page 15435 Technical Corrigendum No. 1 22 February 2005 28 February 2010 Implementation of ISO Corrigendum April 2008 Implementation of ISO Corrigendum September 2004. A C1 A C1 A C2 A C2EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO4074 February2002 ICS11.200 SupersedesEN600:1996 Englishve

7、rsion NaturallatexrubbercondomsRequirementsandtestmethods (ISO4074:2002) Prservatifsmasculinsenlatexdecaoutchoucnaturel Exigencesetmthodesdessai KondomeausNaturkautschuklatexAnforderungenund Prfverfahren ThisEuropeanStandardwasapprovedbyCENon2February2002. CENmembersareboundtocomplywiththeCEN/CENELE

8、CInternalRegulationswhichstipulatetheconditionsforgivingthisEuropean Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcerningsuchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeoff

9、icialversions(English,French,German).Aversioninanyotherlanguagemadebytranslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusastheofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,G

10、ermany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHES KOMITEE FR NORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitation

11、inanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO4074:2002EINESO04:4702(20E) 2 CORRECTED20020417 Foreword Thisdocument(ISO4074:2002)hasbeenpreparedbyTechnicalCommitteeISO/TC157 “Mechanicalcontraceptives“incollaborationwithTechnicalCommitteeCEN/TC205“Nonactive medicaldevices

12、“,thesecretariatofwhichisheldbyBSI. ThisdocumentsupersedesEN600:1996. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionand theEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). ForrelationshipwithEUDirective(s),seeinformativeAnnexZA,whichisanintegr

13、alpartofthis standard. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofan identicaltextorbyendorsement,atthelatestbyAugust2002,andconflictingnationalstandardsshall bewithdrawnatthelatestbyAugust2002. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardso

14、rganizationsofthe followingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta, Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnitedKingdom. Endorsementnotice ThetextoftheInternationa

15、lStandardISO4074:2002hasbeenapprovedbyCENasaEuropean Standardwithoutanymodifications.iii Contents Page 1 Scope . 1 2 Normative references . 1 3 Terms and definitions 1 4 Quality verification 3 5 Design 3 6 Burst volume and pressure . 4 7 Tests for stability and shelf life 5 8 Freedom from holes 6 9

16、Visible defects . 6 10 Package integrity 6 11 Packaging and labelling 7 12 Test report 9 Annexes A Sampling plans intended for assessing compliance of a continuing series of lots of sufficient number to allow the switching rules to be applied . 10 B Sampling plans intended for assessing compliance o

17、f isolated lots . 11 C Determination of total lubricant for condoms in individual containers. 12 D Determination of length. 14 E Determination of width 16 F Determination of thickness 17 G Determination of bursting volume and pressure . 19 H Oven treatment for condoms. 22 I Determination of force an

18、d elongation at break of test pieces of condoms 23 J Determination of shelf life by real-time stability studies. 25 K Guidance on conducting and analysing accelerated ageing studies 27 L Testing for holes. 30 M Tests for package integrity 35 O Calibration of air inflation equipment for determination

19、 of burst volume and pressure . 38 P Rationale. 41 Bibliography. 45v Introduction The intact latex film has been shown to be a barrier to human immunodeficiency virus (HIV), other infectious agents responsible for the transmission of sexually transmitted infections (STIs) and to spermatozoa. In orde

20、r to help ensure that condoms are effective for contraceptive purposes and for assisting in the prevention of transmission of STIs, it is essential that condoms fit the penis properly, are free from holes, have adequate physical strength so as not to break during use, are correctly packaged to prote

21、ct them during storage and are correctly labelled to facilitate their use. All these issues are addressed in this International Standard. The condom and any lubricant, additive, dressing, individual packaging material or powder applied to it should neither contain nor liberate substances in amounts

22、that are toxic, sensitizing, locally irritating or otherwise harmful under normal conditions of storage or use. Reference should be made to ISO 10993 for test methods to evaluate the safety of condoms particularly in respect of the risk of local irritation and sensitization. Condoms are medical devi

23、ces. Therefore they should be produced under a good quality management system. Reference should be made, for example to the ISO 9000-series, ISO 14971-1 and one of the relevant standards: ISO 13485 or ISO 13488. Condoms are non-sterile medical devices but manufacturers should take appropriate precau

24、tions to minimize microbiological contamination of the product during manufacture and packaging. This first edition of ISO 4074 requires manufacturers to conduct stability tests to estimate the shelf life of any new or modified condom before the product is placed on the market and to initiate real-t

25、ime stability studies. These requirements are described in clause 7. The real-time stability test can be considered as part of the manufacturers requirement to conduct post-marketing surveillance on their products. These requirements are intended to ensure that manufacturers have adequate data to su

26、pport shelf-life claims before products are placed on the market and that these data are available for review by regulatory authorities, third-party test laboratories and purchasers. They are also intended to limit the need for third parties to conduct long-term stability studies. A guideline (ISO 1

27、6038) for the application of this International Standard is under development by ISO/TC 157/WG 14. This International Standard contains requirements for tensile properties (force at break) when a manufacturer makes a claim for “extra strength”. Annex I contains the test method for determination of f

28、orce and elongation at break, as it may be useful in the quality system of a manufacturer and in very special cases in a purchasers contract. Background information including technical explanations relating to certain clauses of this International Standard is given in annex P. Where this is relevant

29、, the appropriate clause in annex P is referenced in the text.Natural latex rubber condoms Requirements and test methods 1 Scope This International Standard specifies the minimum requirements and the test methods to be used for condoms made from natural rubber latex which are supplied to consumers f

30、or contraceptive purposes and to assist in the prevention of sexually transmitted infections. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amen

31、dments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest ed

32、ition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 188, Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance tests ISO 2859-1:1999, Sampling procedures for inspection by attributes Part

33、1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied EN 980, Graphical symbols for use in the labelling of medical devices 3 Terms and definitions For

34、 the purposes of this International Standard, the terms and definitions given in ISO 2859-1 and the following apply. 3.1 acceptable quality limit AQL quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling ISO 2859-1:1999, defin

35、ition 3.1.26 NOTE Process average is also defined in ISO 2859-1. 3.2 condom medical device used by consumers, which is intended to be retained on the penis during sexual activity, for purposes of contraception and prevention of sexually transmitted infections NOTE If a consumer could responsibly con

36、sider a device to be a condom (due to its shape, packaging, etc.), it is considered a condom for the purpose of this International Standard. 3.3 consumer package package, intended for distribution to a consumer, containing one or more individual containers 1 A C1 A C12 3.4 expiry date stated date af

37、ter which a condom should not be used 3.5 identification number number, or combination of numerals, symbols or letters used by a manufacturer on consumer packages to identify uniquely the lot numbers of individual condoms contained in that package, and from which it is possible to trace those lots t

38、hrough all stages of packaging and distribution NOTE When the consumer package contains only one kind of condom, then the identification number may be the same as the lot number. But if the consumer package contains several different types of condom, for instance condoms of different shapes or colou

39、rs, then the identification number will be different from the lot number. 3.6 individual container immediate wrapping of a single condom 3.7 inspection level relationship between lot size and sample size. NOTE For description, see ISO 2859-1:1999, 10.1. 3.8 lot collection of condoms of the same desi

40、gn, colour, shape, size and formulation, manufactured at essentially the same time, using the same process, raw materials of the same specifications, common equipment and packed with the same lubricant and any other additive or dressing in the same type of individual container NOTE This Internationa

41、l Standard does not specify the size of a lot, but it is possible for a purchaser to do so as part of the purchasing contract. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for productio

42、n is . 3.9 lot number number or combination of numerals, symbols or letters used by the manufacturer to identify a lot of individually packaged condoms, and from which it is possible to trace that lot through all stages of manufacture up to packaging NOTE For testing purposes, sampling is conducted

43、by lot number, not identification number. See requirements in clause 4. 3.10 lot test test to assess the compliance of a lot NOTE A lot test may be limited to include only those parameters which may change from lot to lot. 3.11 non-visible hole hole in the condom that is not visible under normal or

44、corrected vision but is detected by leakage when rolling on absorbant paper 3.12 sampling plan specific plan which indicates the number of units of product from each lot which are to be inspected (sample size or series of sample sizes) and the associated criteria for determining the acceptability of

45、 the lot (acceptance and rejection numbers) 500 0003 3.13 shelf life time from date of manufacture to the claimed expiry date 3.14 visible hole hole or tear in the condom that is visible under normal or corrected vision 4 Quality verification Condoms are mass-produced articles manufactured in very l

46、arge quantities. Inevitably there will be some variation between individual condoms, and a small proportion of condoms in each production run may not meet the requirements in this International Standard. Further, the majority of the test methods described in this International standard are destructi

47、ve. For these reasons the only practicable method of assessing compliance with this International Standard is by testing a representative sample from a lot or series of lots. Basic sampling plans are given in ISO 2859-1. Reference should be made to ISO/TR 8550 for guidance on the selection of an acc

48、eptance sampling system, scheme or plan for the inspection of discrete items in a lot. When on-going verification is required of the quality of condoms, it is suggested that, instead of concentrating solely on evaluation of the final product, the party concerned also directs his attention to the manufacturers quality system. In this conne