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1、BRITISH STANDARD BS ISO 8009-4:1996 Reusable rubber contraceptive diaphragms Part 4: Freedom from visible defects ICS 11.200 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-4:1996 This British Standard, having been prepared under
2、 the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 August 1997 BSI 09-1999 ISBN 0 580 27888 3 National foreword This British Standard reproduces verbatim ISO 8009-4:1996 and implements it as the UK national
3、standard. Together with BS ISO 8009-1 to BS ISO 8009-3 and BS ISO 8009-5 to BS ISO 8009-10, it supersedes BS 4028:1989 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/30, Mechanical contraceptives, which has the responsibility to: aid enquirers to
4、understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represente
5、d on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence I
6、ndex”, or using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself co
7、nfer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the ISO title page, pages ii to iv, pages 1 to 3 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This w
8、ill be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-4:1996 BSI 09-1999i Contents Page National forewordInside
9、 front cover Forewordiii Text of ISO 8009-41 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheff
10、ieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-4:1996 ii BSI 09-1999 Contents Page Forewordiii 1Scope1 2Principle1 3Apparatus1 4Procedure1 5Test report1 Figure 1 Example of suitable apparatus for inspection over a lamp2 Figure 2 Example of suitable apparatus f
11、or inspection by inflation3 Descriptors: Birth control, contraceptives, contraceptive devices, reusable equipment, caps (contraceptives), tests, detection, defects. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-4:1996 BSI 09-19
12、99iii Foreword 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 committees. Each member body interested in a subject for whi
13、ch 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 International Electrotechnical Commission (IEC) on all m
14、atters of electrotechnical standardization. Draft International 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. International Standard ISO 80
15、09-4 was prepared by Technical Committee ISO/TC 157, Mechanical contraceptives. This second edition cancels and replaces the first edition (ISO 8009-4:1985), of which it constitutes a minor revision. ISO 8009 consists of the following parts, under the general title Reusable rubber contraceptive diap
16、hragms. Part 1: Classification, sampling and requirements; Part 2: Determination of size; Part 3: Determination of dome thickness; Part 4: Freedom from visible defects; Part 5: Determination of tensile properties; Part 6: Determination of deterioration after accelerated ageing; Part 7: Determination
17、 of compression resistance of coil spring and flat spring diaphragms; Part 8: Determination of twisting during compression of coil spring and flat spring diaphragms; Part 9: Packaging and labelling; Part 10: Recommendations for storage. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44
18、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-4:1996 BSI 09-19991 1 Scope This part of ISO 8009 specifies two alternative methods for determining visible defects in reusable
19、rubber contraceptive diaphragms: inspection over a lamp and inspection by inflation. The methods are of equal validity. 2 Principle Visual inspection of the rim and the distended dome of the diaphragm. 3 Apparatus 3.1 Apparatus for inspection over a lamp, consisting of a transparent cylinder with a
20、light source inside. The cylinder shall not be heated by the light source to the extent that it affects the rubber in the diaphragm. Figure 1 illustrates an example of a suitable apparatus. 3.2 Apparatus for inspection by inflation, consisting of an apparatus that will hold the rim of the diaphragm
21、correctly and maintain the dome in a distended state by air inflation. Figure 2 illustrates an example of suitable apparatus. 4 Procedure 4.1 Inspection over a lamp Inspect the rim and then pull the diaphragm over the glass cylinder (3.1) so that the rubber is distended about 75 % of its maximum dis
22、tention. Move the diaphragm around and inspect for defects in the dome with normal or corrected vision. 4.2 Inspection by inflation Inspect the rim and then inflate the diaphragm with air using the apparatus in 3.2 for 1 min so that the rubber is distended about 75 % of its maximum distention, and e
23、xamine the inflated diaphragm for defects in the dome with normal or corrected vision. 5 Test report The test report shall include the following information: a) identification of the sample; b) statement of test method used, c) number of samples tested; d) number of diaphragms with one or more of th
24、e following visible serious defects: hole in dome, exposed spring, broken spring, distorted shape and illegible labelling; e) number of diaphragms with one or more of the following visible defects: thin spots in the dome (including the edges), embedded particles, surface tackiness and any other defe
25、cts likely to affect the serviceability of the diaphragm; f) date of testing Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-4:1996 2 BSI 09-1999 Figure 1 Example of suitable apparatus for inspection over a lamp Licensed Copy: sh
26、effieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-4:1996 BSI 09-19993 Figure 2 Example of suitable apparatus for inspection by inflation Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS I
27、SO 8009-4:1996 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions Br
28、itish Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity
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33、rice of standards. For details of these and other benefits contact Membership Administration. Tel: 020 8996 7002. Fax: 020 8996 7001. Copyright Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of the publications of the international standardization bodies. Except
34、 as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the free use, in th
35、e course of implementing the standard, of necessary details such as symbols, and size, type or grade designations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained. If permission is granted, the terms may include royalty payments or a licensing agreement. Details and advice can be obtained from the Copyright Manager. Tel: 020 8996 7070. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:11:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
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