1、STDOIS0 8007-1-ENGL 1797 853703 0705387 bL3 W INTERNATIONAL STANDARD IS0 8009-1 First edition 1997-04-1 5 Reusable rubber contraceptive diaphragms - Part 1: Classification, sampling and requirements Diaphragmes contraceptifs rutilisables en caoutchouc - Partie 1: Classification, chantillonnage et ex
2、igences This material is reproduced from IS0 documents under International Organization for Standardization (ISO) Copyright License number IHSIICCIl996. Not for resale. No part of these IS0 documents may be reproduced in any form, electronic retrieval system or otherwise, except as allowed in the co
3、pyright law of the country of use, or with the prior written consent of IS0 (Case postale 56,1211 Geneva 20, Switzerland, Fax +41 22 734 10 79), IHS or the IS0 Licensors members. Reference number IS0 8009-1 :1997(E) Copyright International Organization for Standardization Provided by IHS under licen
4、se with ISONot for ResaleNo reproduction or networking permitted without license from IHS-,-,- STD-IS0 8007-1-ENGL 1977 i851703 0705388 55T IS0 8009-1 :1997(E) Contents Page 1 2 3 4 5 6 7 8 9 10 11 12 13 Scope Normative references Definit ions Sampling Classification Materials Design Dimensions Tens
5、ile properties of the rubber dome Mechanical properties of rim and spring in type 1 and type 2 diaphragms Freedom from visible defects Packaging and labelling Recommendations for storage Annex A Bibliography 5 O IS0 1997 All rights reserved. Unless otherwise specified, no part of this publication ma
6、y be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case postale 56 CH-121 1 Genve 20 Switzerland Internet central Oiso.ch X.400 c=ch;
7、 a400net; p=iso; o=isocs; s=central Printed in Switzerland Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS-,-,- STDaISO BOOS-1-ENGL 1997 W 9851703 0705389 q9b IS0 8009-1 :199
8、7(E) IS0 Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interested in a subject for
9、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. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on al
10、l matters 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 IS0
11、 8009-1 was prepared by Technical Committee ISOTTC 157, Mechanical contraceptives. IS0 8009 consists 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 o
12、f 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 of compression resistance of coil spring and flat spring diaphragms - Part 8: Determination of twisting duri
13、ng compression of coil spring and flat spring diaphragms - Part 9: Packaging and labelling - Part 70; Recommendations for storage Annex A of this part of IS0 8009 is for information only. . Ill Copyright International Organization for Standardization Provided by IHS under license with ISONot for Res
14、aleNo reproduction or networking permitted without license from IHS-,-,-STDoISO 8007-1-ENGL 1997 9 485L703 0705390 LOB IS0 8009-1 : 1 997( E) 0 IS0 Introduction The sampling plans and acceptable quality levels (AQLs) given in this part of IS0 8009 are intended for referee testing. Manufacturers may
15、devise and apply other quality control measures during production. These measures will be specific to production 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 amou
16、nts that are toxic, sensitizing, locally irritating or otherwise harmful under normal conditions of use. Reference should be made to relevant parts of IS0 10993. A manufacturer may be required by a certification or inspection authority or by a purchaser to provide a certificate of composition and/or
17、 other properties. iv Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STD-IS0 8007-3-ENGL 1997 4853903 0705393 OLi4 9 INTERNATIONAL STANDARD 0 IS0 IS0 8009-1 :1997(E) Reu
18、sable rubber contraceptive diaphragms Part 1 : Classification, sampling and requirements 1 Scope This part of IS0 8009 gives a classification of, and specifies requirements for, reusable rubber diaphragms (hereafter called diaphragms) supplied in consumer packages for contraceptive use. This part of
19、 IS0 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 standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 8009. At the ti
20、me of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 8009 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of tEC and IS0 maintain r
21、egisters of currently valid International Standards. IS0 2859-1: -, Sampling procedures for inspection by attributes - Part 7: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection. IS0 8009-2: 1985, Reusable rubber contraceptive diaphragms - Part 2: Determination of siz
22、e. IS0 8009-3: 1985, Reusable rubber contraceptive diaphragms - Part 3: Determination of dome thickness. IS0 8009-4: 1996, Reusable rubber contraceptive diaphragms - Part 4: Freedom from visible defects. IS0 8009-5: 1996, Reusable rubber contraceptive diaphragms - Part 5: Determination of tensile pr
23、operties. IS0 8009-6: 1985, Reusable rubber contraceptive diaphragms - Part 6: Determination of deterioration after accelerated ageing. IS0 8009-7: 1985, Reusable rubber contraceptive diaphragms - Part 7: Determination of compression resistance of coil spring and flat spring diaphragms. IS0 8009-8:1
24、985, Reusable rubber contraceptive diaphragms - Part 8: Determination of twisting during compression of coil spring and flat spring diaphragms. IS0 8009-9: 1985, Reusable rubber contraceptive diaphragms - Part 9: Packaging and labelling. IS0 8009-10:1985, Reusable rubber contraceptive diaphragms - P
25、art 70: Recommendations for storage. 3 Definitions For the purposes of this part of IS0 8009, the definitions given in IS0 2859-1 and the following definition apply. 3.1 lot; batch Number of diaphragms of the same design, colour, shape, size and latex formulation, manufactured at essentially the sam
26、e time, using the same process, common lots of raw materials, common equipment and personnel. NOTE -This part of IS0 8009 does not specify the size of a lot, but it may be possible for a purchaser to do so as part of the purchasing contract. To be published. (Revision of IS0 2859-1:1989) 1 Copyright
27、 International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS-,-,-IS0 8009-1 : 1 997( E) o IS0 4 Sampling Sampling and establishment of the sampling plan shall be carried out as described in IS0 28
28、59-1. It is necessary to know the lot size in order to derive from IS0 2859-1 the number of samples to be tested. The lot size will vary among manufacturers and is regarded as part of the process and quality controls used by the manufacturer. 5 Classification Diaphragms shall be classified into the
29、following types: Type 1: coil-spring diaphragm, also known as a helically wound diaphragm. Type 2: flat-spring diaphragm, 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. 6 Mater
30、ials 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 under normal condit
31、ions 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 diaphragm shall consist o
32、f 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 The reinforcing sp
33、ring 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 8.1 Diameter The n
34、ominal diameters of preferred sizes are: 45mm, 50mm, 55mm, 60mm, 65mm, 70mm, 75mm, 80 mm, 85 mm, 90 mm, 95 mm, 100 mm and 105 mm. 2 Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license fro
35、m IHS-,-,-0 IS0 IS0 8009-1 :1997(E) When tested in accordance with IS0 8009-2, the two specified measurements shall not differ by more than 4% of the nominal size. The mean of these two measurements shall equal the nominal size within a tolerance of I 2 mm. Examine 13 diaphragms of each size. No dia
36、phragm 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 be less than 0,20 mm. Examine 13 diaphragms of each size. No diaphragm thickness shall fall outside the limits. 9 Tens
37、ile properties of the rubber dome 9.1 Tensile strength Examine 13 diaphragms of each size in accordance with IS0 8009-5. The median tensile strength shall not be lower than 20 MPa before oven treatment and 15 MPa after oven treatment in accordance with IS0 8009- 6. 9.2 Elongation at break Examine 13
38、 diaphragms of each size in accordance with IS0 8009-5. The median elongation at break shall not be lower than 700% before oven treatment and 600% after oven treatment in accordance with IS0 8009- 6. 10 Mechanical properties of rim and spring in type 1 and type 2 diaphragms NOTE -This clause does no
39、t apply to type 3 diaphragms. 10.1 Compression resistance When measured in accordance with IS0 8009-7, the distance between the load points of each diaphragm shall not be lower than 55% and not greater than 85% of the original diameter. Examine 13 diaphragms. Each diaphragm diameter shall show a com
40、pression resistance within the range 55 Yo to 85 % of the original diameter. 10.2 Twisting during compression When tested in accordance with IS0 8009-8, the diaphragm shall not show an angle of twist greater than 20“. Each lot shall be sampled in accordance with IS0 2859-1, general inspection level
41、I, but utilizing minimum sample size and corresponding acceptance/rejection number equivalent to sample size code letter K. When tested in accordance with IS0 8009-8, the compliance level shall be an AQL of 1 ,O%. If the lot size is less than 125 pieces, all diaphragms shall be tested. 11 Freedom fr
42、om visible defects When inspected in accordance with IS0 8009-4, the diaphragm shall not show any visible defects Each lot shall be sampled in accordance with IS0 2859-1, general inspection level I, but utilizing minimum sample size and corresponding acceptancelrejection number equivalent to sample
43、size code letter K. 3 Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STD.ISO 8009-1-ENGL 1977 q851903 0705394 853 IS0 8009-1 : 1 997( E) o IS0 For the serious defects: h
44、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 IS0 8009-4, the compliance level shall be an AQL of 1,0%. If the lot size is les
45、s than 125 pieces, all diaphragms shall be tested. 12 Packaging and labelling The diaphragm shall be packaged and labelled as specified in IS0 8009-9. Examine 13 diaphragms of each size. Each packed diaphragm shall comply with.IS0 8009-9. 13 Recommendations for storage Recommendations for storage ar
46、e given in IS0 8009-10. 4 Copyright International Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS-,-,-0 IS0 STDOIS0 8007-1-ENGL 1777 4853903 0705375 77T IS0 8009-1 : 1 997( E) Annex A (informative)
47、Bibliography 1 I IS0 Guide 7:1994, Requirements for standards suitable for product certification. 21 IS0 2230: -, Vulcanized rubber - Guide to storage. 3 IS0 9002:1994, Quality systems - Model for quality assurance in production and installation. 4 IS0 13485:1996, Quality systems - Medical devices -
48、 Particular requirements for the application of IS0 900 1. 51 IS0 13488:1996, Quality systems - Medical devices - Particular requirements for the application of /SO 9002. 6 IS0 10993 (all parts), Biological evaluation of medical devices To be published. (Revision of IS0 2230:1973) 5 Copyright Intern
49、ational Organization for Standardization Provided by IHS under license with ISONot for ResaleNo reproduction or networking permitted without license from IHS-,-,-STD*ISO 8007-1-ENGL 1997 D Li851703 0705LiLi7 718 IS0 8009-1 :I 997(E) Descriptors: birth control, contraceptives, contraceptive devices, reusable equipment, caps (contraceptives), classification, design, specifications
