1、BSI Standards Publication BS ISO 8009:2014 Mechanical contraceptives Reusable natural and silicone rubber contraceptive diaphragms Requirements and testsBS ISO 8009:2014 BRITISH STANDARD National foreword This British Standard is the UK implementation of ISO 8009:2014. The UK participation in its pr
2、eparation 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 for its
3、correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 86138 3 ICS 11.200 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and
4、 Strategy Committee on 30 November 2014. Amendments issued since publication Date Text affectedBS ISO 8009:2014 ISO 2014 Mechanical contraceptives Reusable natural and silicone rubber contraceptive diaphragms Requirements and tests Contraceptifs mcaniques Diaphragmes contraceptifs rutilisables en ca
5、outchouc Performances et essais INTERNATIONAL STANDARD ISO 8009 Second edition 2014-11-15 Reference number ISO 8009:2014(E)BS ISO 8009:2014ISO 8009:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publicatio
6、n 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 address below or ISOs member body in the country of
7、 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 SwitzerlandBS ISO 8009:2014ISO 8009:2014(E)Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms a
8、nd definitions . 1 4 Sampling 2 5 Classification 2 6 Materials . 2 7 Design 2 7.1 General . 2 7.2 Rim 2 7.3 Reinforcing spring 2 7.4 Spring ends . 2 7.5 Dome and rim 3 8 Dimensions . 3 8.1 Diameter . 3 8.2 Dome thickness 3 9 Tensile properties of the dome 3 9.1 Tensile strength 3 9.2 Elongation at b
9、reak . 3 10 Mechanical properties of rim and spring Type 1 and Type 2 diaphragms .4 10.1 Compression resistance 4 10.2 Twisting during compression 4 11 Freedom from visible defects 4 12 Test report . 4 13 Packaging, labelling, and storage 5 13.1 Packaging . 5 13.2 Labelling . 5 13.3 Storage . 5 Anne
10、x A (normative) Determination of size . 7 Annex B (normative) Determination of dome thickness. 8 Annex C (normative) Determination of tensile properties . 9 Annex D (normative) Determination of deterioration after accelerated ageing by oven treatment 11 Annex E (normative) Determination of compressi
11、on and fatigue resistances of coil-spring and flat-spring diaphr agms 13 Annex F (normative) Det ermination of twisting during c ompr ession of c oil-spring and flat spring diaphragms 16 Annex G (normative) Determination of visible defects .19 Annex H (normative) Test report 23 Annex I (normative) I
12、nstructions for care and use of reusable rubber contraceptive diaphragms 24 Bibliography .26 ISO 2014 All rights reserved iiiBS ISO 8009:2014ISO 8009:2014(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).
13、The work of preparing International 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-g
14、overnmental, in liaison with ISO, also 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 describe
15、d in the ISO/IEC Directives, Part 1. 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 t
16、he possibility that some of the elements 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
17、 list of patent declarations received (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 meaning of ISO specific terms and expressions related to conformity assessment, as
18、 well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics. This second editi
19、on cancels and replaces the first edition, ISO 8009:2004, of which it constitutes a minor revision. It also incorporates the amendment ISO 8009:2004/Amd1:2012. iv ISO 2014 All rights reservedBS ISO 8009:2014ISO 8009:2014(E) Introduction Diaphragms are medical devices, therefore, they should be produ
20、ced under a good quality management system. Reference should be made, for example to the ISO 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 lev
21、el of defects in the products. As diaphragms are intended for re-use, manufacturers should strive 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.
22、 ISO 2014 All rights reserved vBS ISO 8009:2014BS ISO 8009:2014Mechanical contraceptives Reusable natural and silicone rubber contraceptive diaphragms Requirements and tests 1 Scope This International Standard specifies the minimum requirements and test methods to be used for reusable diaphragms mad
23、e from natural rubber and silicone rubber. These diaphragms are intended for contraceptive use. This International Standard is not applicable to other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges, and vaginal sheaths. 2 Normative references The following docu
24、ments, in whole or in part, are normatively referenced in this document and are indispensable for its 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, vulcaniz
25、ed or thermoplastic Accelerated ageing and heat resistance tests ISO 463, Geometrical Product Specifications (GPS) Dimensional measuring equipment Design and metrological characteristics of mechanical dial gauges ISO 2859-1:1999, Sampling procedures for inspection by attributes Part 1: Sampling sche
26、mes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-10, Bi
27、ological evaluation of medical devices Part 10: Tests for irritation and skin sensitization 3 T erms a nd definiti ons For the purpose of this document, the terms and definitions given in ISO 2859-1 and the following apply. 3.1 lot batch collection of diaphragms of the same design, colour, shape, si
28、ze, and formulation, manufactured at essentially the same time, using the same process, common lots of raw materials, common equipment and personnel Note 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 cont
29、ract. Depending on the method of manufacture, multiple sizes can be produced in a defined lot/batch. In such cases, traceability can be maintained by using both the lot number and the size. INTERNATIONAL ST ANDARD ISO 8009:2014(E) ISO 2014 All rights reserved 1BS ISO 8009:2014ISO 8009:2014(E) 4 Samp
30、ling Sampling and establishment of the sampling plan shall be carried out as described in ISO 2859-1. NOTE It is necessary 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 q
31、uality controls used by the manufacturer. 5 Classific ation Diaphragms shall be classified into the following types: a) Type 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
32、 diaphragm. c) Ty p e 3: A rcing-spr ing diaphrag m, a lso k now n as an arcing-bend diaphrag m or bow-bend diaphrag m. 6 Materials The diaphragm, 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
33、 manufacturing process, biocompatibility assessments shall be conducted in accordance with ISO 10993-1. Testing for cytotoxicity, in accordance 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 exem
34、pt from this requirement. Where practicable, manufacturers should take steps to recommend spermicides that minimize irritant effects. Accredited laboratories shall be used for all biocompatibility testing. Regulatory bodies might also specify local requirements and require results to be interpreted
35、by a qualified toxicologist. Any toxicologists assessment report shall state that the product is safe under normal conditions of use. NOTE Many latex products that have been established as safe, including diaphragms and medical gloves, can exhibit a positive cytotoxic response when tested according
36、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 diaphragm cannot necessarily be determined to be unsuitable for use based solely on cytotoxicity data. 7 Design 7.1 General The diaphragm shall consist of a dome and a
37、n integral peripheral rim. The dome of the diaphragm and the portion forming the rim shall be one continuous film. 7.2 Rim The rim of the diaphragm shall be reinforced with a spring, which shall be sufficiently rigid to hold the rim in a flat, circular configuration. 7.3 Reinforcing spring The reinf
38、orcing spring shall be completely encapsulated and centrally located within the rim. 7.4 Spring ends The ends of the spring shall be joined in such a 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 rim
39、The dome and rim shall have a uniform, smooth, and non-tacky finish. 8 Dimensions 8.1 Diameter The nominal diameters of preferred sizes shall be 55 mm, 60 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
40、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 of 2 mm. Examine 13 diaphragms of each size. No diaphragm diameter shall fall outside the limits. 8.2 Dome thickness When tested in accordance w
41、ith 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 dome 9.1 Tensile strength When tested in accordance with Annex C, the median tensile strength of 13 diaphragms of each size shall not be less than the values gi
42、ven 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 given in Table 1. 9.2 Elongation at break When tested in accordance with Annex C, the median elongation at break of 13 untreated diaphragms
43、 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 of each size shall not be less than the values given in Table 1. Table 1 Minimum median tensile properties Property Natural rubber un
44、treated Natural rubber oven-treated Silicone rubber untreated Silicone rubber oven-treated Tensile strength, MPa 15 11 7 7 Elongation at break, % 650 500 350 350 ISO 2014 All rights reserved 3BS ISO 8009:2014ISO 8009:2014(E) 10 Mechanical properties of rim and spring Type 1 and Type 2 diaphragms 10.
45、1 Compression resistance When 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 from compression, of each diaphragm shall not be lower than 55 % and not greater than 85 % of the original diameter. After
46、 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 shall show no signs of deterioration when examined by normal or corrected vision. The degree of twist after 1 000 compress
47、ions, 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 suppliers are similarly certified, may use the repeated compression testing part of this method as a type test. In th
48、at case, lot-by-lot testing shall consist of a single compression, and measurement of the compression resistance. 10.2 Twisting during compression When tested in accordance with Annex F, the diaphragm shall not show an angle of twist greater than 20. Each lot shall be sampled in accordance with ISO
49、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 visible defects When 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 do
