BS ISO 29942-2011 Prophylactic dams Requirements and test methods《防护大坝 要求和试验方法》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 29942:2011Prophylactic dams Requirements and testmethodsBS ISO 29942:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 29942:2011

2、.The UK participation in its preparation was entrusted to TechnicalCommittee CH/157, Mechanical contraceptives.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. User

3、s are responsible for its correctapplication. BSI 2011ISBN 978 0 580 65907 2ICS 11.200Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2011.Amendments issue

4、d since publicationDate Text affectedBS ISO 29942:2011Reference numberISO 29942:2011(E)ISO 2011INTERNATIONAL STANDARD ISO29942First edition2011-07-01Prophylactic dams Requirements and test methods Membranes prophylactiques Exigences et mthodes dessai BS ISO 29942:2011ISO 29942:2011(E) COPYRIGHT PROT

5、ECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs m

6、ember body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedBS ISO 29942:2011ISO 29942:2011(E) ISO 2011 All rights reser

7、ved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Quality verification 3 5 Design.4 6 Barrier properties 5 7 Biocompatibility.5 8 Surface finish.5 9 Tensile properties5 10 Tests for stability and shelf-life .6 11 Freedom from holes7 12 Visi

8、ble defects .7 13 Packaging and labelling7 14 Data sheets 10 Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of lots of sufficient number to allow the switching rules to be applied.11 Annex B (normative) Sampling plans intended for assessing compliance of

9、isolated lots .12 Annex C (normative) Determination of length and width .13 Annex D (normative) Determination of dam thickness.14 Annex E (informative) Guidance for risk assessment.15 Annex F (normative) Determination of barrier properties using the bacteriophage method .17 Annex G (normative) Deter

10、mination of tensile properties21 Annex H (normative) Oven conditioning22 Annex I (normative) Determination of shelf-life by real-time stability studies.23 Annex J (informative) Guidance on conducting and analysing accelerated ageing studies25 Annex K (normative) Testing for holes.27 Bibliography29 B

11、S ISO 29942:2011ISO 29942:2011(E) iv ISO 2011 All rights reservedForeword ISO (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 c

12、ommittees. 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 t

13、he International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft Internat

14、ional Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be

15、 the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 29942 was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics. BS ISO 29942:2011ISO 29942:2011(E) ISO 2011 All rights reserved vIntrod

16、uction A prophylactic dam is used to cover parts of the human body during sexual contact. The prophylactic dam (hereinafter also referred to as “dam”) provides coverage to the external female genitalia or the anal area. Non-porous, intact, polymer films have been demonstrated as barriers to the huma

17、n immunodeficiency virus (HIV) and other infectious agents responsible for the transmission of sexually transmitted infections (STls). To be effective, it is essential that dams be free from holes and defects, have adequate physical properties so as not to break during use, be correctly packaged to

18、protect them during storage and be correctly labelled to facilitate their use. To be safe, it is essential that the dam and additive, dressing, individual packaging material or powder applied to it neither contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating or

19、otherwise harmful under normal conditions of storage or use. Prophylactic dams are non-sterile medical devices; however, a clean environment is essential to minimize microbiological and particulate contamination of the product during manufacturing and packaging. To ensure a high-quality product, it

20、is essential that it be designed and produced under a good quality management system. See ISO 13485 and ISO 14971 for more details on risk management and quality management. It is intended that manufacturers conduct stability tests to estimate the shelf-life of any new or modified design before the

21、product is placed on the market. These tests are intended to ensure that manufacturers have adequate data to support shelf-life claims before products are placed on the market and that these data are available for review by regulatory authorities, test laboratories and purchasers. They are also inte

22、nded 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. BS ISO 29942:2011BS ISO 29942:2011INTERNATIONAL STANDARD ISO 29942:2011(E) ISO 2011 All rights

23、reserved 1Prophylactic dams Requirements and test methods 1 Scope This International Standard specifies the minimum requirements and test methods for prophylactic dams used to assist in the prevention of sexually transmitted infections. 2 Normative references The following referenced documents are i

24、ndispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 34-1, Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trou

25、ser, angle and crescent test pieces ISO 37, Rubber, vulcanized or thermoplastic Determination of tensile stress-strain properties ISO 188, Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance tests ISO 2859-1:1999, Sampling procedures for inspection by attributes Part 1: Sampli

26、ng schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 4074, Natural latex rubber condoms Requirements and test methods ISO/TR 8550-1, Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 1: Acceptance sampling I

27、SO/TR 8550-2, Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots Part 2: Sampling by attributes ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-5, Biological evalu

28、ation of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity ISO 13485, Medical devices Quality

29、management systems Requirements for regulatory purposes ISO 14971, Medical devices Application of risk management to medical devices ISO 15223 (all parts), Medical devices Symbols to be used with medical device labels, labelling and information to be supplied BS ISO 29942:2011ISO 29942:2011(E) 2 ISO

30、 2011 All rights reserved3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 2859-1 and the following apply. 3.1 acceptance quality limit AQL quality level that is the worst tolerable process average when a continuing series of lots is submitted for acce

31、ptance sampling ISO 2859-1:1999, definition 3.1.26 3.2 consumer package package intended for distribution to a consumer, containing one or more individual containers of prophylactic dams 3.3 date of manufacture date of formation of the prophylactic dam 3.4 expiry date date after which the prophylact

32、ic dam cannot be used 3.5 prophylactic dam piece of polymer film that prevents the transmission of micro-organisms, which can cause sexually transmitted infections, and is designed to cover the anal area and/or the external female genitalia 3.6 identification number number, or combination of numeral

33、s, symbols or letters used by a manufacturer on consumer packages to uniquely identify the lot numbers of individual prophylactic dams contained in that package, and from which it is possible to trace those lots through all stages of manufacturing, packaging and distribution NOTE Whenever the consum

34、er package contains only one kind of prophylactic dam, the identification number can be the same as the lot number. However, if the consumer package contains several different types of prophylactic dam, for instance prophylactic dams of different shapes or colours, the identification number is diffe

35、rent from the lot numbers. 3.7 individual container primary package containing a prophylactic dam 3.8 inspection level relationship between lot size and sample size NOTE For a description, see ISO 2859-1:1999, 10.1. 3.9 lot collection of dams of the same design, colour, shape, size and formulation,

36、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 International Standard does not specify the size of a

37、 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 production is 500 000. BS ISO 29942:2011ISO 29942:

38、2011(E) ISO 2011 All rights reserved 33.10 lot number number or combination of numerals, symbols or letters used by the manufacturer to identify a lot of individually packaged dams, and from which it is possible to trace that lot through all stages of manufacture up to packaging 3.11 lot test test t

39、o assess the conformity of a lot NOTE A lot test can be limited to include only those parameters that can change from lot to lot. 3.12 non-visible hole hole in a dam that is not visible under normal or corrected vision, but is detected by a suitable water leak test 3.13 sampling plan specific plan t

40、hat 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 the lot (acceptance and rejection numbers) 3.14 shelf-life period of time from the date of manufacture over wh

41、ich the product is claimed to conform to the specified requirements 3.15 visible hole hole in the dam that is visible under normal or corrected vision before the dam is exposed to water during testing for holes 3.16 visible defect other than hole permanent crease with adhesion of the film, or other

42、materials embedded in the film 4 Quality verification Dams are produced in large quantities. Inevitably there is some variation between individual prophylactic dams. A small proportion of dams in each production run might not meet the requirements of this International Standard. Furthermore, the maj

43、ority of the test methods described in this International Standard are 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. Sampling plans referred to in this Internati

44、onal Standard are identified in ISO 2859-1. Refer to ISO/TR 8550-1 for guidance on acceptance sampling in general, and to ISO/TR 8550-2 for the selection of alternative acceptance sampling systems, for the inspection of discrete items in a lot. For testing purposes, sampling shall be conducted by lo

45、t number, not by identification number. Handling and storage conditions shall be documented before drawing the samples. Sampling plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling plans are given in Annexes A and B. Annex A describes sampling plans based

46、 on ISO 2859-1 and is most applicable to manufacturers or purchasers assessing the conformity of a continuing series of lots. The full level of consumer protection available depends upon the switch to tightened inspection if deterioration in quality is detected. The switching rules cannot offer full

47、 protection for the first two lots tested, but become progressively more effective as the number of lots in a series increases. The sampling plans in Annex A are applicable whenever five or more lots are being tested. BS ISO 29942:2011ISO 29942:2011(E) 4 ISO 2011 All rights reservedAnnex B describes

48、 sampling plans, based on ISO 2859-1, which are recommended for the assessment of isolated lots. It is recommended that these sampling plans be used for the assessment of fewer than five lots, for example in cases of dispute, for referee purposes, for type testing, for qualification purposes or for

49、short runs of continuing lots. It is necessary to know the lot size in order to derive from ISO 2859-1 the number of dams to be tested. The lot size varies between manufacturers and is regarded as part of the process and quality controls used by the manufacturer. Where initial or ongoing quality verification for dams is required, it is suggested that, instead of concentrating solely on evaluation of the final product, the party concerned also assess the manufacturers quality system. ISO 13485 specifies the p