ISO 25841-2014 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、 ISO 2014Female condoms Requirements and test methodsPrservatifs fminins Exigences et mthodes dessaiINTERNATIONAL STANDARDISO25841Second edition2014-01-15Reference numberISO 25841:2014(E)ISO 25841:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless

2、otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, 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 addr

3、ess below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandISO 25841:2014(E) ISO 2014 All rights reserved iiiContents PageForeword vIntrodu

4、ction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Quality verification 35 Design 45.1 General . 45.2 Product insertion feature . 45.3 Retention features 55.4 Lubrication . 55.5 Dimensions . 55.6 Risk assessment . 66 Barrier properties 67 Biocompatibility . 78 Clinical (human us

5、e) investigations . 79 Bursting volume and pressure . 89.1 Minimum values. 89.2 Sampling and requirements 910 Tests for stability and shelf-life . 910.1 General . 910.2 Procedure for determining shelf-life by real-time stability studies 910.3 Procedure for estimating shelf-life based upon accelerate

6、d stability studies . 911 Freedom from holes .1012 Visible defects.1013 Packaging and labelling .1013.1 Package integrity 1013.2 Packaging 1013.3 Labelling 1013.4 Inspection . 1214 Data sheets.13Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of lots of su

7、fficient number to allow the switching rules to be applied 14Annex B (informative) Sampling plans intended for assessing compliance of isolated lots .15Annex C (normative) Determination of lubricant mass for individual female condom containers 16Annex D (normative) Determination of female condom len

8、gth .18Annex E (normative) Determination of female condom width 19Annex F (normative) Determination of female condom thickness 20Annex G (normative) Testing for female condom package integrity .21Annex H (normative) Determination of barrier properties using the bacteriophage method 23Annex I (normat

9、ive) Determination of bursting volume and bursting pressure .28Annex J (normative) Testing for holes .30Annex K (normative) Determination of shelf-life by real-time stability studies .36ISO 25841:2014(E)iv ISO 2014 All rights reservedAnnex L (informative) Guidance on conducting and analysing acceler

10、ated ageing studies 38Bibliography .41ISO 25841:2014(E)ForewordISO (the International 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.

11、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, also take part in the work. ISO collaborates closely with the Internat

12、ional 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. In particular the different approval criteria needed for the differe

13、nt 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 elements of this document may be the subject of patent rights. ISO shall n

14、ot 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 (see www.iso.org/patents).Any trade name used in this document is in

15、formation 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 assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see

16、 the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics.This second edition cancels and replaces the first edition (ISO 25841:2011), which has been technically revised. ISO 2014 All r

17、ights reserved vISO 25841:2014(E)IntroductionA female condom is a sheath that completely lines the vaginal canal and is designated 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).

18、A female 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. Non-porous, intact, polymer films can be effective barriers to human immunodeficien

19、cy virus (HIV), to other infectious agents responsible for the transmission of STls, and to spermatozoa. Female condoms made from polymer films can be effective for contraceptive purposes and in the prevention of STI transmission. To be effective, it is essential that female condoms completely line

20、the vaginal canal, be 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 correctly labelled to facilitate their use.To be safe, it is essential that the female condom and any lubricant, additive

21、, dressing, individual packaging material, or powder applied to it neither 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

22、advised to take appropriate precautions to minimize microbiological contamination of the product during manufacturing 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 exampl

23、e, to ISO 9000, ISO 9001, ISO 9004, ISO 13485, and ISO 14971. To estimate the shelf-life of any new or modified female condom, manufacturers conduct stability tests before the product is placed on the market. This ensures that manufacturers have adequate data to support shelf-life claims and that th

24、ese data are available for review by regulatory authorities, test laboratories, 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 prod

25、uct in the market.Because female condoms are a relatively new class of devices 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 o

26、f internal and external retention features, failure modes, safety, and effectiveness of female condoms. This International Standard 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

27、definition of specifications and test methods by the manufacturer.All these issues are addressed in this International Standard.vi ISO 2014 All rights reservedFemale condoms Requirements and test methods1 ScopeThis International Standard specifies the minimum requirements and test methods for female

28、 condoms, which are supplied to consumers for contraceptive purposes, assisting in the prevention of sexually transmitted infections.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated re

29、ferences, only the edition cited applies. 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 inspe

30、ctionISO 4074, Natural rubber latex 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

31、, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitizationISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicityISO 13485, Medical devices Quality management systems Requirements for regulatory purposesISO 14155 (all parts), C

32、linical investigation of medical devices for human subjectsISO 14971, Medical devices Application of risk management to medical devicesISO 15223 (all parts), Medical devices Symbols to be used with medical device labels, labelling and information to be supplied3 Terms and definitionsFor the purposes

33、 of this document, the terms and definitions in ISO 2859-1 and the following apply.3.1acceptance quality limitAQLquality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance samplingSOURCE: ISO 2859-1:1999, 3.1.263.2consumer packagepackage in

34、tended for distribution to a consumer, containing one or more individual container(s) of female condomsINTERNATIONAL STANDARD ISO 25841:2014(E) ISO 2014 All rights reserved 1ISO 25841:2014(E)3.3date of manufacturedate of formation of the female condom sheath or the date the female condoms are packed

35、 in their individual containers provided, in the latter case, a maximum period of bulk storage is specified and shelf-life studies have been conducted on female condoms that have been subjected to the maximum bulk storage period3.4expiry datedate at the end of the shelf-life3.5female condomsheath th

36、at completely lines the vaginal canal and is designed to be retained in the vagina during sexual intercourse to prevent pregnancy and STIs3.6identification numbernumber, or combination of numerals, symbols, or letters used by a manufacturer on consumer packages to uniquely identify the lot numbers o

37、f individual female condoms contained in that package, and from which it is possible to trace those lots through all stages of manufacturing, packaging, and distributionNote 1 to entry: Whenever the consumer package contains only one kind of female condom, the identification number can be the same a

38、s the lot number. However, if the consumer package contains several different types of female condoms, for instance, female condoms of different shapes or colours, the identification number is different from the lot number.3.7individual containerprimary package containing a single female condom3.8in

39、spection levelrelationship between lot size and sample sizeSOURCE: ISO 2859-1:1999, 10.13.9lotcollection of female condoms of the same design, colour, shape, size, and formulation, manufactured at essentially the same time, using the same process, raw materials of the same specifications, common equ

40、ipment, and packed with the same lubricant and any other additive or dressing in the same type of individual containerNote 1 to entry: This International Standard does not specify the size of a lot; however, it is possible for a purchaser to do so as part of the purchasing contract. Attention is dra

41、wn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000 female condoms.3.10lot numbernumber or combination of numerals, symbols, or letters used by the manufacturer to identify a lot of

42、individually packaged female condoms, and from which it is possible to trace that lot through all stages of manufacture up to packaging3.11lot testtest to assess the conformity of a lotNote 1 to entry: A lot test can be limited to include only those parameters that can change from lot to lot.2 ISO 2

43、014 All rights reservedISO 25841:2014(E)3.12non-visible holehole in a female condom that is not visible under normal or corrected vision, but is detected by a suitable water leak testNote 1 to entry: Leakage during testing can be detected, for instance, by rolling a female condom on absorbent paper.

44、Note 2 to entry: Suitable tests are specified in this International Standard.3.13sampling planspecific plan that 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 t

45、he lot (acceptance and rejection numbers)3.14shelf-lifetime from date of manufacture to the claimed expiry date during which condoms are required to conform to specified requirements3.15total clinical failuresum of female condoms that clinically break or slip, or are associated with misdirection, in

46、vagination, or any additional failure mode(s) identified in the risk assessment which results in reduction of the female condom protective functionNote 1 to entry: Total clinical failure rate is calculated by dividing the number of female condoms with a clinical failure by the number of female condo

47、ms used during sexual intercourse.3.16visible holehole or tear in the female condom that is visible under normal or corrected vision3.17visible defectother than a visible hole, broken, missing, or severely distorted retention feature, permanent crease with adhesion of the film, or unintentional adhe

48、sion of the film to retention feature, including defect particles from female condoms or other materials embedded in the female condom wall4 Quality verificationFemale condoms are produced in large quantities. Inevitably, there is some variation between individual female condoms. A small proportion

49、of female condoms in each production run might not meet the requirements in this International Standard. Furthermore, the majority of the test methods described in this International Standard is destructive. For these reasons, the only practicable method of assessing conformity with this International Standard is by testing a representative sample from a lot or series of lots. Basic sampling plans are identified in ISO 2859-1. See ISO/TR 8550 for guidance on the selection of an acceptance sampling system, scheme, or plan for the