SANS 7439-2009 Copper-bearing intra-uterine contraceptive devices - Requirements tests《含铜的宫内节育避孕器具 试验要求》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23289-4 SANS 7439:2009Edition 1ISO 7439:2002Edition 2SOUTH AFRICAN NATIONAL STANDARD Copper-bearing intra-uterine contraceptive devices Re

4、quirements, tests This national standard is the identical implementation of ISO 7439:2002 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax

5、: +27 12 344 1568 www.sabs.co.za SABS SANS 7439:2009 Edition 1 ISO 7439:2002 Edition 2 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 157, Mechanical contraceptives, in accordance with procedures of the SABS Standards D

6、ivision, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in October 2009. Reference numberISO 7439:2002(E)ISO 2002INTERNATIONAL STANDARD ISO7439Second edition2002-03-15Copper-bearing intra-uterine contraceptive devices Requirements, tests Dispositifs intra-utrin

7、s contenant du cuivre Spcifications, essais SANS 7439:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7439:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may

8、be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accept

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10、file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2002 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any fo

11、rm or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09

12、 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2002 All rights reserved SANS 7439:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7439:2002(E) ISO 2002 All rights reserved iiiForeword ISO (the International Or

13、ganization 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 which a technical committee has been establ

14、ished 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 matters of electrotechnical standardizati

15、on. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. 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 %

16、of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 7439 was prepared by th

17、e European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 157, Mechanical contraceptives, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read “.this European Standard.“ to m

18、ean “.this International Standard.“. This second edition cancels and replaces the first edition of ISO/TR 7439 (ISO/TR 7439:1981), which has been technically revised. Annex ZZ forms a normative part of this International Standard. Annex ZZ provides a list of corresponding International and European

19、Standards for which equivalents are not given in the text. For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives has been removed. SANS 7439:2009This s tandard may only be used and printed by approved subscription and freemailing clients o

20、f the SABS .ISO 7439:2002(E) iv ISO 2002 All rights reservedContentsForewordvIntroductionvi1 Scope12 Normative references.13 Terms and definitions.14 Intended performance25 Design attributes26 Materials37 Design evaluation.38 Manufacturing and inspection79 Sterilization710 Packaging711 Information s

21、upplied by the manufacturer.7Annex ZZ Corresponding International and European Standards for which equivalents are not givenBibliography11in the text 10SANS 7439:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7439:2002(E) ISO 2002 Al

22、l rights reserved vForeword This document (EN ISO 7439:2002) has been prepared by Technical Committee CEN/TC 285 “Non-active surgicalimplants“, the secretariat of which is held by NEN in collaboration with Technical Committee ISO/TC 157“Mechanical contraceptives“.This European Standard shall be give

23、n the status of a national standard, either by publication of an identical text orby endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at thelatest by September 2002.This European Standard needs to be considered in conjunction with EN ISO 14630, whic

24、h contains requirements thatapply to all non-active surgical implants. Although contraceptive intra-uterine devices are not surgical implants, most ofthe requirements of EN ISO 14630 may be applicable to contraceptive intra-uterine devices.This document has been prepared under a mandate given to CEN

25、 by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard : Austria, Belgiu

26、m, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.SANS 7439:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the S

27、ABS .ISO 7439:2002(E) vi ISO 2002 All rights reservedIntroduction Although every foreign object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearingintra-uterine contraceptive devices (IUDs) function is by the continuous release of copper ions. This interferes wi

28、thsome enzymatic functions, immobilizes sperm cells and inhibits fertilization. In addition, growth and development ofthe ovum, tubal function and implantation are inhibited and the biochemical environment of the uterus is altered. Thesecontribute to the high effectiveness of contraception.The effec

29、tiveness of copper-bearing contraceptive intra-uterine devices is many times greater than that of a simpleplastics body.Contraceptive intra-uterine devices containing copper are regarded as medical devices incorporating a substance withan ancillary action and are subject to Council Directive 93/42/E

30、EC of 14 June 1993 concerning medical devices.Contraceptive intra-uterine devices whose primary purpose is to release progestogens are regulated as medicinalproducts and are subject to Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laiddown by law, regulation or ad

31、ministrative action relating to proprietary medicinal products. The relevant essentialrequirements of Annex I to Directive 93/42/EEC apply as far as safety and performance-related device features areconcerned.SANS 7439:2009This s tandard may only be used and printed by approved subscription and free

32、mailing clients of the SABS .ISO 7439:2002(E) ISO 2002 All rights reserved 11 Scope 2 Normative referencesThis European Standard incorporates by dated or undated reference provisions from other publications. Thesenormative references are cited at the appropriate places in the text and the publicatio

33、ns are listed hereafter. For datedreferences, subsequent amendments to, or revisions of, any of these publications apply to this European Standardonly when incorporated in it by amendment or revision. For undated references the latest edition of the publicationreferred to applies (including amendmen

34、ts).EN 540, Clinical investigation of medical devices for human subjects.EN 980, Graphical symbols for use in the labelling of medical devices.EN 1441, Medical devices Risk analysis.EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing (ISO 10993-1 : 1997).EN ISO 14

35、630 : 1997, Non-active surgical implants General requirements (ISO 14630 : 1997).European Pharmacopoeia.3 Terms and definitionsFor the purposes of this standard, the following terms and definitions apply:3.1intra-uterine contraceptive deviceIUDcopper-bearing device placed in the uterine cavity for t

36、he purpose of preventing pregnancy3.2insertion instrumentinstrument designed to place an IUD in the uterine cavity3.3threadattachment to an IUD for the purpose of verifying the presence of and enabling the removal of the IUDNOTE The thread is intended to lie in the cervical canal and the vagina when

37、 the body of the device is placed correctly in the uterinecavity.3.4visco-elastic propertyproperty of an IUD enabling an approximate return to their initial configuration after deformation3.5active surface areasurface area of copper in the IUD that is intended to come into contact with uterine fluid

38、sThis European Standard applies to single-use copper-bearing intra-uterine contraceptive devices and their insertioninstruments. Intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptivedevices whose primary purpose is to release progestogens are not incl

39、uded in the scope of this standard.NOTE Some aspects of this standard can be applicable to medicated intra-uterine devices and intra-uterine devices that do notcontain copper.SANS 7439:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7

40、439:2002(E) 2 ISO 2002 All rights reserved4 Intended performance4.1 GeneralThe requirements of clause 4 of EN ISO 14630:1997 shall apply.4.2 Clinical performanceFor physical requirements see clause 5.An IUD shall meet the following requirements for a period of 3 years (the minimum intended lifetime

41、of use): pregnancy rate 2 per 100 woman years during the 1st year as calculated by life-table analysis; expulsion rate 10 per 100 woman years during the 1st year as calculated by life-table analysis.5 Design attributes5.1 GeneralThe requirements of clause 5 of EN ISO 14630:1997 shall apply.Thread an

42、d copper shall be integral parts of the IUD.5.2 ShapeWhen tested by visual and tactile inspection an IUD shall have a form fitting the uterine cavity and designed in such away as to minimize the risk of perforation and subsequent bowel obstruction. The IUDs and insertion instruments shallnot exhibit

43、 sharp edges.The design of the IUD shall be such that no excessive forces are required for insertion and removal.5.3 Dimensions5.3.1 IUDThe nominal length of an IUD shall not be greater than 36 mm, the nominal width of an IUD shall not be greater than32 mm.When determined as specified in 7.2.1, the

44、dimensions shall be consistent with the specifications as given by themanufacturer within tolerances of 5 %.5.3.2 Copper componentsThe nominal active surface area of copper shall be at least 200 mm2, but shall not be larger than 380 mm2. If copperwire is used, the nominal diameter of the copper wire

45、 shall be at least 0,25 mm.The diameter shall be consistent with the specifications as given by the manufacturer within tolerances of 5 % andthe active surface area within tolerances of 10 %.5.3.3 ThreadWhen determined in accordance with 7.2.2 the length of the thread shall be not less than 100 mm.S

46、ANS 7439:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 7439:2002(E) ISO 2002 All rights reserved 35.3.4 Insertion instrumentThe maximum nominal outer width of the part of an insertion instrument intended to come into contact with th

47、e cervicalcanal shall not be greater than 5 mm.The dimensions shall be consistent with the specifications as given by the manufacturer within tolerances of 5 %.5.4 Tensile forceWhen tested in accordance with 7.3 the IUD, including the thread, shall withstand a tensile force of at least 12 N.5.5 Stab

48、ility5.5.1 Shelf-life stabilityThe IUD shall meet any performance specification given by the manufacturer for the complete duration of the declaredshelf-life.5.5.2 In situ stabilityDuring its intended period of use the copper components shall retain structural integrity and the entire IUD shallwiths

49、tand the tensile force according to 5.4.5.6 Visco-elastic propertyWhen tested in accordance with 7.4 the recovery of any part of the IUD from its original design position shall be suchthat the residual deformation does not exceed 5 mm.5.7 In situ detectionAll parts of the IUD frame shall be detectable by X-ray examinations. If barium sulphate is used in the plasticscomponents as the opaque material its content shall range from 15 % (w/w) to 25 % (w/w), when tested as specified in7.5.6 MaterialsThe requirements of clause 6 of