BS ISO 25841-2017 Female condoms Requirements and test methods《女性用安全套 要求和试验方法》.pdf

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1、Female condoms - Requirements and test methodsBS ISO 25841:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 25841:2017. It supersedes BS ISO 25841:2014 , which is withdrawn.The UK participation

2、 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. Users are responsible

3、for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 87018 7ICS 11.200Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy

4、and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS ISO 25841:2017 ISO 2017Female condoms Requirements and test methodsPrservatifs fminins Exigences et mthodes dessaiINTERNATIONAL STANDARDISO25841Third edition2017-08-15Refere

5、nce numberISO 25841:2017(E)BS ISO 25841:2017ISO 25841:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means,

6、 electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 V

7、ernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 25841:2017ISO 25841:2017(E)Foreword vIntroduction vii1 Scope . 12 Normative references 13 Terms and definitions . 13.1 General terms . 23.2 Terms related to female condom failure modes . 34 Quality

8、verification 55 Lot size 66 Design 66.1 General . 66.2 Product insertion feature . 66.3 Retention features 76.4 Lubrication . 76.5 Dimensions . 86.5.1 Length 86.5.2 Width . 86.5.3 Thickness 86.6 Risk assessment . 97 Barrier properties 98 Biocompatibility . 99 Clinical (human use) investigations 1010

9、 Microbial contamination.1111 Bursting volume and pressure 1111.1 Minimum values 1111.2 Sampling and requirements . 1212 Tests for stability and shelf life 1212.1 General 1212.2 Procedure for determining shelf life by real-time stability studies .1212.3 Procedure for estimating shelf life based upon

10、 accelerated stability studies .1313 Freedom from holes .1314 Visible defects.1315 Packaging and labelling .1315.1 Individual container integrity . 1315.2 Packaging 1315.3 Labelling 1415.3.1 Symbols . 1415.3.2 Individual containers 1415.3.3 Consumer packages 1415.3.4 Additional information for the c

11、onsumer .1515.3.5 Female condoms not distributed in consumer packages.1615.4 Inspection . 1616 Data sheets.17Annex A (normative) Sampling plans intended for assessing conformity of a continuing series of lots of sufficient number to allow the switching rules to be applied 18Annex B (informative) Sam

12、pling plans intended for assessing conformity of isolated lots 19 ISO 2017 All rights reserved iiiContents PageBS ISO 25841:2017ISO 25841:2017(E)Annex C (normative) Determination of lubricant mass for individual female condom containers .20Annex D (normative) Determination of female condom length .2

13、2Annex E (normative) Determination of female condom width 23Annex F (normative) Determination of female condom thickness 24Annex G (normative) Testing for female condom individual container integrity 26Annex H (normative) Determination of barrier properties using the bacteriophage method 28Annex I (

14、informative) Determination of microbial contamination .33Annex J (normative) Determination of bursting volume and bursting pressure38Annex K (normative) Testing for holes .40Annex L (normative) Determination of shelf life by real-time stability studies 47Annex M (informative) Guidance on conducting

15、and analysing accelerated ageing studies 49Bibliography .52iv ISO 2017 All rights reservedBS ISO 25841:2017ISO 25841:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International

16、 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, governmental and non-governmental, in liaison with ISO, a

17、lso 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 Directives, Part 1.

18、 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 is drawn to the possibility that some of the eleme

19、nts 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/or on the ISO list of patent declarations received

20、 (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 voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as wel

21、l as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics

22、.This third edition cancels and replaces the second edition (ISO 25841:2014 ) which has been technically revised.The modifications are as follows: clinical failure mode definitions have been harmonized with ISO 299432; tolerances have been specified for the amount of lubricant applied to the female

23、condom and the length, width and sheath thickness of the female condom. These tolerances are to be applied to the nominal values specified by the manufacturers for these design features; manufacturers are required to specify female condom width and thickness at three locations along the length of th

24、e female condom sheath; manufacturers are required to identify specifications and test methods as appropriate to verify the design and to ensure the quality and consistency of components and materials used for the retention features and any insertion feature used with the female condom; manufacturer

25、s are recommended to 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 female condoms; methods of determining b

26、ioburden levels on female condoms are given in Annex I; detailed changes have been made to the test methods for determining freedom from holes and airburst properties to improve the reproducibility of female condom testing between laboratories and accommodate female condoms made from a wider range o

27、f sheath materials including sheaths made from natural rubber latex; a greater degree of harmonization with ISO 4074 has been achieved for common requirements and definitions; ISO 2017 All rights reserved vBS ISO 25841:2017ISO 25841:2017(E) for female condoms with sheaths made from natural rubber la

28、tex, reference is included in the procedures for estimating provisional shelf lives from accelerated stability studies given in ISO 4074 ; the maximum lot size for female condoms has been limited to 500 000; labelling requirements have been revised and updated.vi ISO 2017 All rights reservedBS ISO 2

29、5841:2017ISO 25841:2017(E)IntroductionA female condom is a sheath that completely lines the vaginal canal and is designed to be retained in the vagina during sexual intercourse and after withdrawal of the penis to prevent pregnancy and transmission of sexually transmitted infections (STIs).A female

30、condom is distinguished from a male condom in that it is retained in the vagina after withdrawal of the penis. The external component of the device can provide some coverage to the external female genitalia. Nonporous, intact, polymer films can be effective barriers to human immunodeficiency virus (

31、HIV), other infectious agents responsible for the transmission of STIs and spermatozoa. Female condoms made from polymer films that are free from holes and defects, have adequate physical properties so as not to break during use, are correctly packaged to protect them during storage and are correctl

32、y labelled to facilitate their correct use, can be effective for contraceptive purposes and in the prevention of sexually transmitted infections (STIs).To be safe, it is essential that the female condom and any lubricant, additive, dressing, individual packaging material or powder applied to it neit

33、her contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating or otherwise harmful under normal conditions of storage or use.Female condoms are non-sterile medical devices but manufacturers are advised to take appropriate precautions to minimize microbiological conta

34、mination of the product during manufacture and packaging. To ensure high quality products, it is essential that female condoms be designed and produced under a good quality management system. Reference can be made, for example, to ISO 9000 , ISO 9004 , ISO 9001 , ISO 13485 and ISO 14971 . To estimat

35、e the shelf life of any new or modified female condom, the manufacturer conducts stability tests before the product is placed on the market. This ensures that manufacturers have adequate data to support shelf-life claims and that these data are available for review by regulatory authorities, test la

36、boratories and purchasers. They are also intended to limit the need for third parties to conduct long-term stability studies. Real-time shelf-life studies are also initiated, but not necessarily completed, prior to placing the product on the market.Because female condoms are a relatively new class o

37、f device and designs of female condoms vary considerably, clinical investigations in humans are necessary to continue to build evidence of safety and efficacy. These investigations enable an assessment of the overall performance of internal and external retention features, failure modes, safety and

38、effectiveness of female condoms. This document represents minimal requirements and test methods and acknowledges that new designs can require further due rigour of retention and other features as well as additional definition of specifications and test methods by the manufacturer.All of these issues

39、 are addressed in this document. ISO 2017 All rights reserved viiBS ISO 25841:2017This page deliberately left blankFemale condoms - Requirements and test methods1 ScopeThis document specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptiv

40、e purposes and for assisting in the prevention of sexually transmitted infections (STIs).2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited a

41、pplies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 2859-1:1999 , Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspectionISO 4074 , Natural rubber la

42、tex male condoms Requirements and test methodsISO 10993-1 , Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 10993-5 , Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicityISO 10993-10 , Biological evaluation of me

43、dical devices Part 10: Tests for irritation and skin sensitizationISO 14155 , Clinical investigation of medical devices for human subjects Good clinical practiceISO 14971 , Medical devices Application of risk management to medical devicesISO 15223 (all parts), Medical devices Symbols to be used with

44、 medical device labels, labelling and information to be suppliedISO 29943-2, Female condoms Guidance on the design, execution, analysis and interpretation of clinical failure mode studies3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 28591 and the fo

45、llowing apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp INTERNATIONAL STANDARD ISO 25841:2017(E) ISO 2017 All rights

46、reserved 1BS ISO 25841:2017ISO 25841:2017(E)3.1 General terms3.1.1acceptable quality limitAQLquality level that is the worst tolerable process average when a continuing series of lots (3.1.9) is submitted for acceptance samplingSOURCE: ISO 2859-1:1999, 3.1.263.1.2consumer packagepackage intended for

47、 distribution to a consumer, containing one or more individual container(s) (3.1.7)of female condom (3.1.5) 3.1.3date of manufacturedate of formation of the female condom (3.1.5) sheath or the date the female condoms are packed in their individual containers (3.1.7) provided, in the latter case, a m

48、aximum period of bulk storage is specified and shelflife studies have been conducted on female condoms that have been subjected to the maximum bulk storage period3.1.4expiry datedate after which the female condom (3.1.5) should not be used3.1.5female condomsheath that completely lines the vaginal ca

49、nal and is designed to be retained in the vagina during sexual intercourse and after withdrawal of the penis to prevent pregnancy and transmission of sexually transmitted infections3.1.6identification numbernumber, or combination of numbers, symbols or letters used by a manufacturer on consumer packages (3.1.2) to uniquely identify the lot numbers (3.1.10) of individual female condoms contained in that package and from which it is possible to trace those lots (3.1.9) through all stages of manufacturing, packaging a