《BS-ISO-8009-1-1997.pdf》由会员分享,可在线阅读,更多相关《BS-ISO-8009-1-1997.pdf(14页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS ISO 8009-1:1997 Reusable rubber contraceptive diaphragms Part 1: Classification, sampling and requirements ICS 11.200 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-1:1997 This British Standard, having been p
2、repared under 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 27885 9 National foreword This British Standard reproduces verbatim ISO 8009-1:1997 and implements it as the
3、 UK national standard. Together with BS ISO 8009-2 to BS ISO 8009-10, it supersedes BS 4028:1989 which is withdrawn.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 understand the text; p
4、resent 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 represented on this committee ca
5、n 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 Index”, or using the “F
6、ind” 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 confer immunity from leg
7、al 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 4 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in th
8、e amendment table on the inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-1:1997 BSI 09-1999i Contents Page National forewordInside front cover Forewordi
9、ii Text of ISO 8009-11 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26
10、 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-1:1997 ii BSI 09-1999 Contents Page Forewordiii Introduction1 1Scope1 2Normative references1 3Definitions1 4Sampling1 5Classification1 6Materials2 7Design2 8Dimensions2 9Tensile properties of the rubber dome2 10Mechanical properties of
11、 rim and spring in type 1 and type 2 diaphragms2 11Freedom from visible defects3 12Packaging and labelling3 13Recommendations for storage3 Annex A (informative) Bibliography4 Descriptors: Birth control, contraceptives, contraceptive devices, reusable equipment, caps (contraceptives), classification,
12、 design, specifications, dimensions, mechanical properties, sampling. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-1:1997 BSI 09-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federati
13、on 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 which a technical committee has been established has the right to be represented on that committee
14、. 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 matters of electrotechnical standardization. Draft International Standards adopted by the techni
15、cal 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 8009-1 was prepared by Technical Committee ISO/TC 157, Mechanical contraceptives. ISO 8009 consis
16、ts of the following parts, under the general title Reusable rubber contraceptive diaphragms: 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; P
17、art 6: Determination of deterioration after accelerated ageing; Part 7: Determination 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: Recomme
18、ndations for storage. Annex A of this part of ISO 8009 is for information only. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) B
19、SI BS ISO 8009-1:1997 BSI 09-19991 Introduction The sampling plans and acceptable quality levels (AQLs) given in this part of ISO 8009 are intended for referee testing. Manufacturers may devise and apply other quality control measures during production. These measures will be specific to production
20、methods and plants, and may differ among manufacturers. The diaphragm, and any lubricant, dressing material or powder applied to it, should neither contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating or otherwise harmful under normal conditions of use. Referenc
21、e should be made to relevant parts of ISO 10993. A manufacturer may be required by a certification or inspection authority or by a purchaser to provide a certificate of composition and/or other properties. 1 Scope This part of ISO 8009 gives a classification of, and specifies requirements for, reusa
22、ble rubber diaphragms (hereafter called diaphragms) supplied in consumer packages for contraceptive use. This part of ISO 8009 does not cover other vaginal contraceptive barriers, such as those known as cervical caps, vaginal sponges and vaginal sheaths. 2 Normative references The following standard
23、s contain provisions which, through reference in this text, constitute provisions of this part of ISO 8009. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 8009 are encouraged to investigate the
24、 possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling plans indexed by acceptable quality level (AQL) for
25、lot-by-lot inspection1). ISO 8009-2:1985, Reusable rubber contraceptive diaphragms Part 2: Determination of size. ISO 8009-3:1985, Reusable rubber contraceptive diaphragms Part 3: Determination of dome thickness. ISO 8009-4:1996, Reusable rubber contraceptive diaphragms Part 4: Freedom from visible
26、defects. ISO 8009-5:1996, Reusable rubber contraceptive diaphragms Part 5: Determination of tensile properties. ISO 8009-6:1985, Reusable rubber contraceptive diaphragms Part 6: Determination of deterioration after accelerated ageing. ISO 8009-7:1985, Reusable rubber contraceptive diaphragms Part 7:
27、 Determination of compression resistance of coil spring and flat spring diaphragms. ISO 8009-8:1985, Reusable rubber contraceptive diaphragms Part 8: Determination of twisting during compression of coil spring and flat spring diaphragms. ISO 8009-9:1985, Reusable rubber contraceptive diaphragms Part
28、 9: Packaging and labelling. ISO 8009-10:1985, Reusable rubber contraceptive diaphragms Part 10: Recommendations for storage. 3 Definitions For the purposes of this part of ISO 8009, the definitions given in ISO 2859-1 and the following definition apply. 3.1 lot; batch number of diaphragms of the sa
29、me design, colour, shape, size and latex formulation, manufactured at essentially the same time, using the same process, common lots of raw materials, common equipment and personnel NOTEThis part of ISO 8009 does not specify the size of a lot, but it may be possible for a purchaser to do so as part
30、of the purchasing contract. 4 Sampling Sampling and establishment of the sampling plan shall be carried out as described in ISO 2859-1. 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 will vary among manufacturers and is regard
31、ed as part of the process and quality controls used by the manufacturer. 5 Classification Diaphragms shall be classified into the following types: 1) To be published. (Revision of ISO 2859-1:1989) Type 1:coil-spring diaphragm, also known as a helically wound diaphragm. Type 2:flat-spring diaphragm,
32、also known as a flat-leaf diaphragm, watch-spring diaphragm or Mensinga diaphragm. Type 3:arcing diaphragm, also known as an arcing-bend diaphragm or bow-bend diaphragm. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-1:1997 2 BS
33、I 09-1999 6 Materials The diaphragm, excluding the spring, shall be made of a rubber compound. The diaphragm and any lubricant, dressing material or powder applied to it should neither contain nor liberate substances in amounts that are toxic, sensitizing, locally irritating, or otherwise harmful un
34、der normal conditions of use and should not have a deleterious effect on the diaphragm. There should be no adverse reaction between the spring and the material from which the diaphragm is made, and the spring should not be harmful to the user under normal conditions of use. 7 Design 7.1 The diaphrag
35、m 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 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 T
36、he reinforcing spring shall be completely encapsulated and centrally located within the rim. 7.4 The ends of the spring shall be joined in such a manner that the joint does not project through the surface of the rim. 7.5 The dome and rim shall have a uniform, smooth, non-tacky finish. 8 Dimensions 8
37、.1 Diameter The nominal diameters of preferred sizes are: 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, 100 mm and 105 mm. When tested in accordance with ISO 8009-2, the two specified measurements shall not differ by more than 4 % of the nominal size. The mean of these
38、 two measurements 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 with 8009-3, the thickness of the diaphragm dome at the thinnest point measured shall not b
39、e less than 0,20 mm. Examine 13 diaphragms of each size. No diaphragm thickness shall fall outside the limits. 9 Tensile properties of the rubber dome 9.1 Tensile strength Examine 13 diaphragms of each size in accordance with ISO 8009-5. The median tensile strength shall not be lower than 20 MPa bef
40、ore oven treatment and 15 MPa after oven treatment in accordance with ISO 8009-6. 9.2 Elongation at break Examine 13 diaphragms of each size in accordance with ISO 8009-5. The median elongation at break shall not be lower than 700 % before oven treatment and 600 % after oven treatment in accordance
41、with ISO 8009-6. 10 Mechanical properties of rim and spring in type 1 and type 2 diaphragms NOTEThis clause does not apply to type 3 diaphragms. 10.1 Compression resistance When measured in accordance with ISO 8009-7, the distance between the load points of each diaphragm shall not be lower than 55
42、% and not greater than 85 % of the original diameter. Examine 13 diaphragms. Each diaphragm diameter shall show a compression resistance within the range 55 % to 85 % of the original diameter. 10.2 Twisting during compression When tested in accordance with ISO 8009-8, the diaphragm shall not show an
43、 angle of twist greater than 20. Each lot shall be sampled in accordance with ISO 2859-1, general inspection level I, but utilizing minimum sample size and corresponding acceptance/rejection number equivalent to sample size code letter K. When tested in accordance with ISO 8009-8, the compliance lev
44、el shall be an AQL of 1,0 %. If the lot size is less than 125 pieces, all diaphragms shall be tested. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-1:1997 BSI 09-19993 11 Freedom from visible defects When inspected in accordanc
45、e with ISO 8009-4, the diaphragm shall not show any visible defects Each lot shall be sampled in accordance with ISO 2859-1, general inspection level I, but utilizing minimum sample size and corresponding acceptance/rejection number equivalent to sample size code letter K. For the serious defects: h
46、ole in the dome, exposed spring, broken spring, distorted shape, illegible marking on the diaphragm and illegible labelling, the compliance level shall be an AQL of 0,4 %. For other defects when tested in accordance with ISO 8009-4, the compliance level shall be an AQL of 1,0 %. If the lot size is l
47、ess than 125 pieces, all diaphragms shall be tested. 12 Packaging and labelling The diaphragm shall be packaged and labelled as specified in ISO 8009-9. Examine 13 diaphragms of each size. Each packed diaphragm shall comply with ISO 8009-9. 13 Recommendations for storage Recommendations for storage
48、are given in ISO 8009-10. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 8009-1:1997 4 BSI 09-1999 Annex A (informative) Bibliography 1 ISO Guide 7:1994, Requirements for standards suitable for product certification. 2 ISO 2230:, Vul
49、canized rubber Guide to storage2). 3 ISO 9002:1994, Quality systems Model for quality assurance in production and installation. 4 ISO 13485:1996, Quality systems Medical devices Particular requirements for the application of ISO 9001. 5 ISO 13488:1996, Quality systems Medical devices Particular requirements for the application of ISO 9002. 6 ISO 10993 (all parts), Biological evaluation of medical devices. 2) To be published. (Revision of ISO 2230:1973) Licensed Copy: sheffieldun sheffieldun, na, Sun No
链接地址:https://www.31doc.com/p-3744410.html