BS ISO 8009-2014 Mechanical contraceptives Reusable natural and silicone rubber contraceptive diaphragms Requirements and tests《机械性避孕法 可重复使用的天然和硅胶避孕器具 要求和试验》.pdf

1、BSI Standards PublicationBS ISO 8009:2014Mechanical contraceptives Reusable natural andsilicone rubber contraceptivediaphragms Requirementsand testsBS ISO 8009:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 8009:2014.The UK participation in its preparatio

2、n 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. Users are responsible for its correctapplic

3、ation. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 86138 3ICS 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 o

4、n 30 November 2014.Amendments issued since publicationDate Text affectedBS ISO 8009:2014 ISO 2014Mechanical contraceptives Reusable natural and silicone rubber contraceptive diaphragms Requirements and testsContraceptifs mcaniques Diaphragmes contraceptifs rutilisables en caoutchouc Performances et

5、essaisINTERNATIONAL STANDARDISO8009Second edition2014-11-15Reference numberISO 8009:2014(E)BS ISO 8009:2014ISO 8009:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized ot

6、herwise 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 address below or ISOs member body in the country of the requester.ISO copyright offic

7、eCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 8009:2014ISO 8009:2014(E)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Sampling 25 Classification

8、26 Materials . 27 Design 27.1 General . 27.2 Rim 27.3 Reinforcing spring 27.4 Spring ends . 27.5 Dome and rim 38 Dimensions . 38.1 Diameter . 38.2 Dome thickness 39 Tensile properties of the dome 39.1 Tensile strength 39.2 Elongation at break . 310 Mechanical properties of rim and spring Type 1 and

9、Type 2 diaphragms . 410.1 Compression resistance 410.2 Twisting during compression 411 Freedom from visible defects 412 Test report . 413 Packaging, labelling, and storage 513.1 Packaging . 513.2 Labelling . 513.3 Storage . 5Annex A (normative) Determination of size . 7Annex B (normative) Determinat

10、ion of dome thickness. 8Annex C (normative) Determination of tensile properties . 9Annex D (normative) Determination of deterioration after accelerated ageing by oven treatment 11Annex E (normative) Determination of compression and fatigue resistances of coil-spring and flat-spring diaphragms 13Anne

11、x F (normative) Determination of twisting during compression of coil-spring and flat spring diaphragms 16Annex G (normative) Determination of visible defects .19Annex H (normative) Test report 23Annex I (normative) Instructions for care and use of reusable rubber contraceptive diaphragms 24Bibliogra

12、phy .26 ISO 2014 All rights reserved iiiBS ISO 8009:2014ISO 8009:2014(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 techn

13、ical 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, also take part in the work. ISO collaborates closely

14、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. In particular the different approval criteria neede

15、d 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 elements of this document may be the subject of patent r

16、ights. 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 (see www.iso.org/patents). Any trade name used in

17、this document is information 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

18、 to Trade (TBT) see 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 8009:2004, of which it constitutes a minor r

19、evision. It also incorporates the amendment ISO 8009:2004/Amd1:2012. iv ISO 2014 All rights reservedBS ISO 8009:2014ISO 8009:2014(E)IntroductionDiaphragms are medical devices, therefore, they should be produced under a good quality management system. Reference should be made, for example to the ISO

20、9000- series, in conjunction with ISO 13485.The sampling plans and acceptance quality limits (AQLs) given in this International Standard are for referee testing. The AQLs represent the maximum tolerable level of defects in the products. As diaphragms are intended for re-use, manufacturers should str

21、ive for entirely defect-free product.Manufacturers can devise and apply additional and alternative quality control measures for their use and after production. These methods can differ among manufacturers. ISO 2014 All rights reserved vBS ISO 8009:2014BS ISO 8009:2014Mechanical contraceptives Reusab

22、le natural and silicone rubber contraceptive diaphragms Requirements and tests1 ScopeThis International Standard specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber. These diaphragms are intended for contraceptive use.Th

23、is International Standard is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges, and vaginal sheaths.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for it

24、s application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 188, Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance testsISO 463, Geometrical Product Specific

25、ations (GPS) Dimensional measuring equipment Design and metrological characteristics of mechanical dial gaugesISO 2859-1:1999, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspectionISO 10993-1, Biological evaluati

26、on 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 medical devices Part 10: Tests for irritation and skin sensitization3 Terms and def

27、initionsFor the purpose of this document, the terms and definitions given in ISO 2859-1 and the following apply.3.1lotbatchcollection of diaphragms of the same design, colour, shape, size, and formulation, manufactured at essentially the same time, using the same process, common lots of raw material

28、s, common equipment and personnelNote 1 to entry: The size of a lot is not specified in this International Standard, but it can be specified by a purchaser as part of a purchasing contract. Depending on the method of manufacture, multiple sizes can be produced in a defined lot/batch. In such cases,

29、traceability can be maintained by using both the lot number and the size.INTERNATIONAL STANDARD ISO 8009:2014(E) ISO 2014 All rights reserved 1BS ISO 8009:2014ISO 8009:2014(E)4 SamplingSampling and establishment of the sampling plan shall be carried out as described in ISO 2859-1.NOTE It is necessar

30、y to know the lot size in order to derive from ISO 2859-1 the number of samples to be tested. The lot size varies among manufacturers, and is regarded as part of the process and quality controls used by the manufacturer.5 ClassificationDiaphragms shall be classified into the following types:a) Type

31、1: Coil-spring diaphragm, also known as a helically wound diaphragm.b) Type 2: Flat-spring diaphragm, also known as a flat-leaf diaphragm, watch-spring diaphragm, or Mensinga diaphragm.c) Type 3: Arcing-spring diaphragm, also known as an arcing-bend diaphragm or bow-bend diaphragm.6 MaterialsThe dia

32、phragm, excluding the spring, shall be made of a natural or silicone rubber compound.For any new product or following a significant change to the formulation or manufacturing process, biocompatibility assessments shall be conducted in accordance with ISO 10993-1. Testing for cytotoxicity, in accorda

33、nce with ISO 10993-5, and for irritation and sensitization, in accordance with ISO 10993-10, shall be conducted. Spermicides applied at the time of use are exempt from this requirement. Where practicable, manufacturers should take steps to recommend spermicides that minimize irritant effects. Accred

34、ited laboratories shall be used for all biocompatibility testing. Regulatory bodies might also specify local requirements and require results to be interpreted by a qualified toxicologist. Any toxicologists assessment report shall state that the product is safe under normal conditions of use.NOTE Ma

35、ny latex products that have been established as safe, including diaphragms and medical gloves, can exhibit a positive cytotoxic response when tested according to ISO 10993-5. While any cytotoxic effect can be of concern, it is primarily an indication of potential for in vivo toxicity, and a diaphrag

36、m cannot necessarily be determined to be unsuitable for use based solely on cytotoxicity data.7 Design7.1 GeneralThe diaphragm shall consist of a dome and an integral peripheral rim. The dome of the diaphragm and the portion forming the rim shall be one continuous film.7.2 RimThe rim of the diaphrag

37、m shall be reinforced with a spring, which shall be sufficiently rigid to hold the rim in a flat, circular configuration.7.3 Reinforcing springThe reinforcing spring shall be completely encapsulated and centrally located within the rim.7.4 Spring endsThe ends of the spring shall be joined in such a

38、manner that the joint does not project through the surface of the rim.2 ISO 2014 All rights reservedBS ISO 8009:2014ISO 8009:2014(E)7.5 Dome and rimThe dome and rim shall have a uniform, smooth, and non-tacky finish.8 Dimensions8.1 DiameterThe nominal diameters of preferred sizes shall be 55 mm, 60

39、mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, and 100 mm.When tested in accordance with Annex A, the two diameter measurements shall not differ by more than 4 % of the nominal size. The mean of these two measurements, called diaphragm diameter, shall equal the nominal size within a tolerance

40、of 2 mm.Examine 13 diaphragms of each size. No diaphragm diameter shall fall outside the limits.8.2 Dome thicknessWhen tested in accordance with Annex B, the thickness of the diaphragm dome at the thinnest point measured shall not be less than 0,20 mm.9 Tensile properties of the dome9.1 Tensile stre

41、ngthWhen tested in accordance with Annex C, the median tensile strength of 13 diaphragms of each size shall not be less than the values given in Table 1.When tested in accordance with Annex D, the median tensile strength of 13 oven-treated diaphragms of each size shall not be less than the values gi

42、ven in Table 1.9.2 Elongation at breakWhen tested in accordance with Annex C, the median elongation at break of 13 untreated diaphragms of each size shall not be less than the values given in Table 1.When tested in accordance with Annex D, the median elongation at break of 13 oven-treated diaphragms

43、 of each size shall not be less than the values given in Table 1.Table 1 Minimum median tensile propertiesPropertyNatural rubber untreatedNatural rubber oven-treatedSilicone rubber untreatedSilicone rubber oven-treatedTensile strength, MPa15 11 7 7Elongation at break, %650 500 350 350 ISO 2014 All r

44、ights reserved 3BS ISO 8009:2014ISO 8009:2014(E)10 Mechanical properties of rim and spring Type 1 and Type 2 diaphragms10.1 Compression resistanceWhen 13 diaphragms are tested in accordance with Annex E, during the first and 1 000th compressions the distance between the load points, i.e. resulting f

45、rom compression, of each diaphragm shall not be lower than 55 % and not greater than 85 % of the original diameter.After the 1 000th compression, the diameter along the axis of compression shall be at least 90 % of the value measured before the test.After the 1 000th compression, the rubber film sha

46、ll show no signs of deterioration when examined by normal or corrected vision.The degree of twist after 1 000 compressions, measured in accordance with Annex F, shall be not more than 20.Manufacturers of diaphragms who are certified to the ISO 9001 quality management system or equivalent, and whose

47、suppliers are similarly certified, may use the repeated compression testing part of this method as a type test. In that case, lot-by-lot testing shall consist of a single compression, and measurement of the compression resistance.10.2 Twisting during compressionWhen tested in accordance with Annex F

48、, the diaphragm shall not show an angle of twist greater than 20.Each lot shall be sampled in accordance with ISO 2859-1:1999, General inspection level I, but at least according to code letter K.When tested in accordance with Annex F, the compliance level shall be an AQL of 1,0 %.11 Freedom from vis

49、ible defectsWhen inspected in accordance with Annex G, the diaphragm shall not show any visible defects.Each lot shall be sampled in accordance with ISO 2859-1:1999, General inspection level I, but at least according to code letter K.The compliance level shall be an AQL of 0,4 % for the following major defects:a) hole in the dome;b) exposed spring;c) broken spring;d) distorted shape;e) illegible marking on the diaphragm;f) illegible labelling.For minor defects, when tested in accordance with Annex G, the compliance level