DIN EN ISO 4074-2017 Natural rubber latex male condoms - Requirements and test methods (ISO 4074 2015) German version EN ISO 4074 2015《天然乳胶男用避孕套 要求和试验方法(ISO 4074-2015) 德文版本EN ISO 4.pdf

1、September 2017 English price group 26No 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 11.200!%jke“2717266www.din.deD

2、IN EN ISO 4074Natural rubber latex male condoms Requirements and test methods (ISO 4074:2015);English version EN ISO 4074:2015,English translation of DIN EN ISO 4074:2017-09Kondome aus Naturkautschuklatex fr Mnner Anforderungen und Prfverfahren (ISO 4074:2015);Englische Fassung EN ISO 4074:2015,Engl

3、ische bersetzung von DIN EN ISO 4074:2017-09Prservatifs masculins en latex de caoutchouc naturel Exigences et mthodes dessai (ISO 4074:2015);Version anglaise EN ISO 4074:2015,Traduction anglaise de DIN EN ISO 4074:2017-09SupersedesDIN EN ISO 4074:201607www.beuth.deDocument comprises 70 pagesDTransla

4、tion by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.08.17 DIN EN ISO 4074:2017-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 4074:2015) has been prepared by Technical Committee ISO/TC 157 “Non-systemic cont

5、raceptives and STI barrier prophylactics” (Secretariat: DSM, Malaysia) in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body involved in its preparation was DIN-Norme

6、nausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-04 AA “Condoms and intrauterine devices”. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 2859-1 DIN ISO 2859-1 ISO 3534-2:2006 DIN ISO 3534-2:2013-12 IS

7、O 9000 DIN EN ISO 9000 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-5 DIN EN ISO 10993-5 ISO 10993-10 DIN EN ISO 10993-10 ISO 11737-1:2006 DIN EN ISO 11737-1:2006-08 ISO 13485 DIN EN ISO 13485 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO/IEC 17025 DIN EN ISO/IEC 17025 International Stan

8、dard ISO 4074:2014 was published in 2014. However, the standard has not been adopted at European level and thus also not at German national level. In 2015, following a “minor revision”, the standard was published as a new edition of ISO 4074:2015. In May 2016, this “minor revision” was adopted at Ge

9、rman national level. However, during the editing process, several parts were missing so that the standard was reissued in July 2016. Following notes from Austria concerning the edition of July 2016 and a recheck of the German translation, a new edition had been agreed upon due to various deficiencie

10、s. Amendments This standard differs from DIN EN ISO 4074:2002-07, DIN EN ISO 4074 Corrigendum 1:2005-03 and DIN EN ISO 4074 Corrigendum 2:2008-08 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

11、been added; c) it is recommended that manufacturers establish procedures for the periodic monitoring of microbial contamination (en: bioburden) as part of their quality management system including requirements for the absence of specific pathogens and limits for total viable counts on finished condo

12、ms. Methods of determining 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

13、or safety are to be substantiated by clinical investigation; DIN EN ISO 4074:2017-09 3 e) a minimum airburst volume of 28,0 dm3has been introduced for condoms with mid-body widths greater than or equal to 65,0 mm and not more than 75,0 mm; f) for the radius of the inner edge of the clamping collar,

14、wherever it contacts the inflated condom, a minimum of 2 mm has been specified (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 wat

15、er or electrolyte specified in the freedom from holes test have been increased for condoms that have mid-body widths greater than or equal to 56 mm and/or are longer than 210 mm; i) when conducting the electrical test for freedom from holes, the voltage is now measured from the time the condom is fi

16、rst immersed and for up to 10 s after full immersion; j) the method of test for freedom from holes specified in ASTM D3492 8 has 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 inspect

17、ed 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 the informative Annex P to provide guidance to regulatory authorit

18、ies, notified bodies and other interested parties when assessing condoms that fall outside the normative size range specified in this International Standard; m) amendments have been made to the methods for determining the shelf life of condoms including a simplified procedure for determining the she

19、lf life by accelerated stability studies based on fixed ageing periods at 50 C; n) testing for freedom from holes, airburst properties and package integrity is required when conducting stability studies to establish that condoms meet the minimum stability requirements specified in this International

20、 Standard and when determining condom shelf lives; o) the procedure for determining the thickness of a condom by the micrometer method is described in detail; p) as regards the determination of the amount of lubricant on the condom, an alternative method of removing the lubricant from the condom usi

21、ng an aqueous surfactant solution has been included; q) the labelling requirements including the additional information to be supplied with the condom have been revised. Compared with DIN EN ISO 4074:2016-05, the following corrections have been made: a) list item b) under Clause 4 has been included;

22、 b) Clause 5 has been included and all subsequent clauses have been renumbered. Compared with DIN EN ISO 4074:2016-07, the following corrections have been made: a) in C.3.3.9, the following sentence has been included after the third sentence: “Repeat the rinse one more time.”; b) in M.3.3.7, Table M

23、.2, in the header line “Mid-body condom width”, line “40 to 49,5” was changed to “45 to 49,5”; DIN EN ISO 4074:2017-09 4 c) in M.3.3.8, the second sentence was corrected as follows: “Seal the condom by twisting it less than 25 mm from the open end, for approximately 1,5 revolutions, and remove it fr

24、om the mount.”; d) the use of terms was unified throughout the document. Previous editions DIN 58993: 1991-02 DIN EN 600: 1996-04 DIN EN ISO 4074: 2002-07, 2016-05, 2016-07 DIN EN ISO 4074 Corrigendum 1: 2005-03 DIN EN ISO 4074 Corrigendum 2: 2008-08 DIN EN ISO 4074:2017-09 5 National Annex NA (info

25、rmative) Bibliography DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process DIN EN ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in

26、 vitro cytotoxicity DIN EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization DIN EN ISO 11737-1:2006-08, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products (ISO 11737-1

27、:2006) DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to

28、 be supplied Part 1: General requirements DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspectio

29、n DIN ISO 3534-2:2013-12, Statistics Vocabulary and symbols Part 2: Applied statistics (ISO 3534-2:2006) DIN EN ISO 4074:2017-09 6 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 4074 November 2015 ICS 11.200 Supersedes EN ISO 4074:2002English Version Natura

30、l rubber latex male condoms - Requirements and test methods (ISO 4074:2015) Prservatifs masculins en latex de caoutchouc naturel -Exigences et mthodes dessai (ISO 4074:2015) Kondome aus Naturkautschuklatex fr Mnner - Anforderungen und Prfverfahren (ISO 4074:2015) This European Standard was approved

31、by CEN on 16 July 2015. 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 references concerning such national standa

32、rds 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 member into its own language and not

33、ified 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, France, Germany, Greece, Hungary, I

34、celand, 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 EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Man

35、agement Centre: Avenue Marnix 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 4074:2015 EForeword 8Introduction 101 Scope 112 Normative references . 113 Terms and definitions 114 Quality verification .

36、135 Lot size . 136 Biocompatibility 147 Microbial contamination. 148 Product claims . 149 Design . 149.1 Integral bead 149.2 Lubrication 149.3 Dimensions 159.3.1 Length. 159.3.2 Width 159.3.3 Thickness . 1510 Bursting volume and pressure 1511 Stability and shelf life . 1611.1 General 1611.2 Minimum

37、stability requirements . 1611.3 Procedure for determining shelf life by real-time stability studies . 1711.4 Estimating shelf life based upon accelerated stability studies . 1712 Freedom from holes . 1713 Visible defects. 1814 Package integrity of individual container . 1815 Packaging and labelling

38、. 1815.1 Packaging 1815.2 Labelling 1815.2.1 General. 1815.2.2 Symbols . 1815.2.3 Individual container . 1815.2.4 Consumer package 1915.2.5 Condoms not distributed in consumer packages .2115.3 Inspection . 2116 Test report 21Annex A (normative) Sampling plans intended for assessing compliance of a c

39、ontinuing series of lots of sufficient number to allow the switching rules to be applied 22Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .23Annex C (normative) Determination of total lubricant for condoms in individual containers 24Annex D (normative) Determ

40、ination of length .28Contents PageEuropean foreword 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 6 .DIN EN ISO 4074:2017-09 EN ISO 4074:2015 (E) 2 Annex H (normative) Determination of bursting volume

41、and pressure 39Annex I (normative) Oven treatment for condoms 41Annex J (informative) Determination of force and elongation at break of test pieces of condoms .42Annex K (normative) Determination of shelf life by real-time stability studies .45Annex L (informative) Guidance on conducting and analysi

42、ng accelerated ageing studies 48Annex M (normative) Testing for holes 50Annex N (normative) Testing for package integrity 56Annex O (informative) Calibration of air inflation equipment for determination of bursting volume and pressure .58Annex P (informative) Recommendations for testing condoms that

43、 fall outside of the size ranges specified in ISO 4074 .62Bibliography .64Annex E (normative) Determination of width .30Annex F (normative) Determination of thickness .31Annex G (informative) Determination of microbial contamination .34DIN EN ISO 4074:2017-09 EN ISO 4074:2015 (E) 3 European foreword

44、 This document (EN ISO 4074:2015) has been prepared by Technical Committee ISO/TC 157 “Non-systemic 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

45、 given the status of a national standard, either by publication of an identical text or by endorsement, 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 ma

46、y 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 4074:2002. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associatio

47、n, 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 undated references, the latest editio

48、n 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 superseded 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 version of the ISO or IEC standard,