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1、 Reference number ISO 7439:2002(E) ISO 2002 INTERNATIONAL STANDARD ISO 7439 Second edition 2002-03-15 Copper-bearing intra-uterine contraceptive devices Requirements, tests Dispositifs intra-utrins contenant du cuivre Spcifications, essais Copyright International Organization for Standardization Pro
2、vided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:34:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7439:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes lic
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5、een taken to ensure that the 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 rep
6、roduced or utilized in any form 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
7、 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2002 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:3
8、4:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7439:2002(E) ISO 2002 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Interna
9、tional 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-governmental, in liaison with
10、ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standar
11、ds 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. Attention is drawn to the possibility that some of the elements of this International Standard may b
12、e 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 the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 157, Mechanical contraceptives, in accord
13、ance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read “.this European Standard.“ to mean “.this International Standard.“. This second edition cancels and replaces the first edition of ISO/TR 7439 (ISO/TR 7439:1981), which
14、has been technically revised. Annex ZZ forms a normative part of this International Standard. Annex ZZ provides a list of corresponding International and European Standards for which equivalents are not given in the text. For the purposes of this International Standard, the CEN annex regarding fulfi
15、lment of European Council Directives has been removed. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:34:17 MDTNo reproduction or networking permitted without license from IH
16、S -,-,- ISO 7439:2002(E) iv ISO 2002 All rights reserved Contents Forewordv Introduction vi 1Scope1 2Normative references.1 3Terms and definitions.1 4Intended performance2 5Design attributes2 6Materials3 7Design evaluation.3 8Manufacturing and inspection7 9Sterilization7 10Packaging7 11Information s
17、upplied by the manufacturer.7 Annex ZZ Corresponding International and European Standards for which equivalents are not given Bibliography11 in the text 10 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 N
18、ot for Resale, 04/20/2007 04:34:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7439:2002(E) ISO 2002 All rights reserved v Foreword This document (EN ISO 7439:2002) has been prepared by Technical Committee CEN/TC 285 “Non-active surgical implants“, the secretariat o
19、f which is held by NEN in collaboration with Technical Committee ISO/TC 157 “Mechanical contraceptives“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national st
20、andards shall be withdrawn at the latest by September 2002. This European Standard needs to be considered in conjunction with EN ISO 14630, which contains requirements that apply to all non-active surgical implants. Although contraceptive intra-uterine devices are not surgical implants, most of the
21、requirements of EN ISO 14630 may be applicable to contraceptive intra-uterine devices. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN/CENELEC
22、 Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden
23、, Switzerland and the United Kingdom. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:34:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7439:
24、2002(E) vi ISO 2002 All rights reserved Introduction Although every foreign object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearing intra-uterine contraceptive devices (IUDs) function is by the continuous release of copper ions. This interferes with some enzy
25、matic functions, immobilizes sperm cells and inhibits fertilization. In addition, growth and development of the ovum, tubal function and implantation are inhibited and the biochemical environment of the uterus is altered. These contribute to the high effectiveness of contraception. The effectiveness
26、 of copper-bearing contraceptive intra-uterine devices is many times greater than that of a simple plastics body. Contraceptive intra-uterine devices containing copper are regarded as medical devices incorporating a substance with an ancillary action and are subject to Council Directive 93/42/EEC of
27、 14 June 1993 concerning medical devices. Contraceptive intra-uterine devices whose primary purpose is to release progestogens are regulated as medicinal products and are subject to Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or admi
28、nistrative action relating to proprietary medicinal products. The relevant essential requirements of Annex I to Directive 93/42/EEC apply as far as safety and performance-related device features are concerned. Copyright International Organization for Standardization Provided by IHS under license wit
29、h ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:34:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7439:2002(E) ISO 2002 All rights reserved 1 1 Scope 2Normative references This European Standard incorporates by dated or undated ref
30、erence provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to, or revisions of, any of these publications apply to this European Standard only when incorp
31、orated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 540, Clinical investigation of medical devices for human subjects. EN 980, Graphical symbols for use in the labelling of medical devices. EN 1441, Medica
32、l devices Risk analysis. EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing (ISO 10993-1 : 1997). EN ISO 14630 : 1997, Non-active surgical implants General requirements (ISO 14630 : 1997). European Pharmacopoeia. 3Terms and definitions For the purposes of this st
33、andard, the following terms and definitions apply: 3.1 intra-uterine contraceptive device IUD copper-bearing device placed in the uterine cavity for the purpose of preventing pregnancy 3.2 insertion instrument instrument designed to place an IUD in the uterine cavity 3.3 thread attachment to an IUD
34、for the purpose of verifying the presence of and enabling the removal of the IUD NOTE The thread is intended to lie in the cervical canal and the vagina when the body of the device is placed correctly in the uterine cavity. 3.4 visco-elastic property property of an IUD enabling an approximate return
35、 to their initial configuration after deformation 3.5 active surface area surface area of copper in the IUD that is intended to come into contact with uterine fluids This European Standard applies to single-use copper-bearing intra-uterine contraceptive devices and their insertion instruments. Intra
36、-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive devices whose primary purpose is to release progestogens are not included in the scope of this standard. NOTE Some aspects of this standard can be applicable to medicated intra-uterine devices and intra
37、-uterine devices that do not contain copper. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:34:17 MDTNo reproduction or networking permitted without license from IHS -,-,- IS
38、O 7439:2002(E) 2 ISO 2002 All rights reserved 4Intended performance 4.1General The requirements of clause 4 of EN ISO 14630:1997 shall apply. 4.2Clinical performance For physical requirements see clause 5. An IUD shall meet the following requirements for a period of 3 years (the minimum intended lif
39、etime 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. 5Design attributes 5.1General The requirements of clause 5 of EN ISO 14630:1997 shall apply.
40、 Thread and copper shall be integral parts of the IUD. 5.2Shape When tested by visual and tactile inspection an IUD shall have a form fitting the uterine cavity and designed in such a way as to minimize the risk of perforation and subsequent bowel obstruction. The IUDs and insertion instruments shal
41、l not exhibit sharp edges. The design of the IUD shall be such that no excessive forces are required for insertion and removal. 5.3Dimensions 5.3.1IUD The nominal length of an IUD shall not be greater than 36 mm, the nominal width of an IUD shall not be greater than 32 mm. When determined as specifi
42、ed in 7.2.1, the dimensions shall be consistent with the specifications as given by the manufacturer within tolerances of 5 %. 5.3.2Copper components The nominal active surface area of copper shall be at least 200 mm 2, but shall not be larger than 380 mm2. If copper wire is used, the nominal diamet
43、er of the copper wire shall be at least 0,25 mm. The diameter shall be consistent with the specifications as given by the manufacturer within tolerances of 5 % and the active surface area within tolerances of 10 %. 5.3.3Thread When determined in accordance with 7.2.2 the length of the thread shall b
44、e not less than 100 mm. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 04:34:17 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 7439:2002(E) ISO 20
45、02 All rights reserved 3 5.3.4Insertion instrument The maximum nominal outer width of the part of an insertion instrument intended to come into contact with the cervical canal shall not be greater than 5 mm. The dimensions shall be consistent with the specifications as given by the manufacturer with
46、in tolerances of 5 %. 5.4Tensile force When tested in accordance with 7.3 the IUD, including the thread, shall withstand a tensile force of at least 12 N. 5.5Stability 5.5.1Shelf-life stability The IUD shall meet any performance specification given by the manufacturer for the complete duration of th
47、e declared shelf-life. 5.5.2In situ stability During its intended period of use the copper components shall retain structural integrity and the entire IUD shall withstand the tensile force according to 5.4. 5.6Visco-elastic property When tested in accordance with 7.4 the recovery of any part of the
48、IUD from its original design position shall be such that the residual deformation does not exceed 5 mm. 5.7In situ detection All parts of the IUD frame shall be detectable by X-ray examinations. If barium sulphate is used in the plastics components as the opaque material its content shall range from 15 % (w/w) to 25 % (w/w), when tested as specified in 7.5. 6Materials The requirements of clause 6 of EN ISO 14630:1997 shall apply. The plastics body including the substance confe