1、August 2015Translation by DIN-Sprachendienst.English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.200!%DVF“2335135www.din.deDDIN EN ISO 7439Copper-bearing contraceptive intrauterine devices Requirements and tests (ISO 7439:2015);English version EN ISO 7439:2015,English translation of DIN EN ISO 7439:2015-08Kupferhaltige Intrauterinpessare zur Empfngnisverhtung Anforderungen und Prfungen (ISO
3、7439:2015);Englische Fassung EN ISO 7439:2015,Englische bersetzung von DIN EN ISO 7439:2015-08Dispositifs contraceptifs intra-utrins contenant du cuivre Exigences et essais (ISO 7439:2015);Version anglaise EN ISO 7439:2015,Traduction anglaise de DIN EN ISO 7439:2015-08SupersedesDIN EN ISO 7439:2011-
4、09www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 19 pages07.15 DIN EN ISO 7439:2015-08 2 A comma is used as the decimal marker. National foreword This document (EN ISO 7439:2015) has been prepared by Technical Committee ISO/TC 157 “Non
5、-systemic contraceptives and STI barrier prophylactics” (Secretariat: DSM, Malaysia) in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (DIN Standards
6、 Committee Medicine), Working Committee NA 063-01-04 AA Kondome und Intrauterinpessare. The DIN Standards corresponding to the International Standards referred to in this document are as follows: *) The contents of the ISO 14155-1 and ISO 14155-2 standards series have been revised in 2011 and combin
7、ed in one standard, ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice, which has been adopted as DIN EN ISO 14155:2012-01, Clinical investigation of medical devices for human subjects Good clinical practice. ISO 10993-1 DIN EN ISO 10993-1 ISO 14155-1 DIN
8、EN ISO 14155-1 *)ISO 14630 DIN EN ISO 14630 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 Amendments This standard differs from DIN EN ISO 7439:2011-09 as follows: a) reference to ISO 14630 has been updated; b) the standard has been editorially revised; c) Annex ZA has been deleted. Prev
9、ious editions DIN EN ISO 7439: 2002-10, 2010-12, 2011-09 DIN EN ISO 7439:2015-08 3 National Annex NA (informative) Bibliography DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 14155-1, Clinical investigation of me
10、dical devices for human subjects Part 1: General require-ments DIN EN ISO 14630, Non-active surgical implants General requirements DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, la
11、belling and information to be supplied Part 1: General requirements DIN EN ISO 7439:2015-08 4 This page is intentionally blank EN ISO 7439April 2015 ICS 11.200 Supersedes EN ISO 7439:2011English Version Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) Dispos
12、itifs contraceptifs intra-utrins contenant du cuivre - Exigences et essais (ISO 7439:2015) Kupferhaltige Intrauterinpessare zur Empfngnisverhtung -Anforderungen und Prfungen (ISO 7439:2015) This European Standard was approved by CEN on 13 September 2014. CEN members are bound to comply with the CEN/
13、CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Cent
14、re or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the
15、 official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherl
16、ands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. E
17、N ISO 7439:2015 EEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG2DIN EN ISO 7439:2015-08 EN ISO 7439:2015 (E) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms an
18、d definitions 5 4 Intended performance 6 4.1 General 6 4.2 Clinical performance 6 5 Design attributes 6 5.1 General 6 5.2 Shape . 6 5.3 Dimensions . 6 5.3.1 IUD . 6 5.3.2 Copper components 6 5.3.3 Thread . 7 5.3.4 Insertion instrument. 7 5.4 Tensile force . 7 5.5 Stability . 7 5.5.1 Shelf-life stabi
19、lity 7 5.5.2 In situ stability 7 5.6 Visco-elastic property 7 5.7 In situ detection 7 6 Materials 7 7 Design evaluation . 8 7.1 General 8 7.2 Determination of dimensions 8 7.3 Determination of tensile force 8 7.3.1 Principle 8 7.3.2 Apparatus 8 7.3.3 Procedure 8 7.3.4 Test report . 8 7.4 Test of vis
20、co-elastic property (memory test) 9 7.4.1 Principle 9 7.4.2 Procedure 9 7.4.3 Test report . 9 7.5 Determination of barium sulfate content and identification of barium and sulfate 9 7.5.1 Ash content test . 9 7.5.2 Identity test . 9 7.6 Pre-clinical evaluation . 10 7.7 Clinical evaluation 10 8 Manufa
21、cturing and inspection 11 9 Sterilization . 11 10 Packaging . 11 11 Information to be supplied by the manufacturer 12 11.1 General 12 11.2 Labelling of the primary container . 12 11.3 Labelling of the secondary container 12 11.4 Instructions for use 12 11.5 Information intended for the woman 13 Bibl
22、iography 15 Foreword This document (EN ISO 7439:2015) has been prepared by Technical Committee ISO/TC 157 Non-systemic contraceptives and STI barrier prophylactics in collaboration Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This European St
23、andard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2015, and conflicting national standards shall be withdrawn at the latest by October 2015. Attention is drawn to the possibility that some of the elements o
24、f this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 7439:2011. This document has been prepared under a mandate given to CEN by the European Commission and the European Fre
25、e Trade Association, and supports essential requirements of EU Directive. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Den
26、mark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement n
27、otice The text of ISO 7439:2015 has been approved by CEN as EN ISO 7439:2015 without any modification. “”3DIN EN ISO 7439:2015-08EN ISO 7439:2015 (E)IntroductionAlthough every foreign object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearing contraceptive intra
28、uterine devices (IUDs) function is by the continuous release of copper ions. This interferes with some enzymatic functions, immobilizes sperm cells and inhibits fertilization. These contribute to the high effectiveness of the contraception.The effectiveness of copper-bearing IUDs is many times great
29、er than that of a simple plastics body.Contraceptive IUDs containing copper are regarded as medical devices incorporating a substance with an ancillary action and are subject to the European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.Contraceptive IUDs whose primary purpo
30、se is to release progestogens are regulated as medicinal products and are subject to the European Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. The relevant essential
31、 requirements of Annex I to Directive 93/42/EEC apply as far as safety and performance-related device features are concerned. It is advisable that significant changes in the design of the IUD, insertion device, specification or insertion technique be validated.4DIN EN ISO 7439:2015-08 EN ISO 7439:20
32、15 (E) 1 ScopeThis International Standard specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments.It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.NOTE
33、 Some aspects of this International Standard can be applicable to medicated intrauterine devices and IUDs not containing copper.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated referen
34、ces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 14155-1, Clinical investigation of me
35、dical devices for human subjects Part 1: General requirementsISO 14630:2012, Non-active surgical implants General requirementsISO 14971, Medical devices Application of risk management to medical devicesISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and informat
36、ion to be supplied Part 1: General requirementsEuropean Pharmacopoeia (Ph. Eur.)1)3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1contraceptive intrauterine deviceIUDcopper-bearing device placed in the uterine cavity for the purpose of preventin
37、g pregnancy3.2insertion instrumentinstrument designed to place an IUD in the uterine cavity3.3threadattachment to an IUD for the purposes of verifying the presence and enabling the removal of the IUDNote 1 to entry: The thread is intended to lie in the cervical canal and the vagina when the body of
38、the device is placed correctly in the uterine cavity.1) European Directorate for the Quality of Medicines (EDQM) of the Council of Europe.5DIN EN ISO 7439:2015-08EN ISO 7439:2015 (E)3.4visco-elastic propertyproperty of an IUD enabling an approximate return to its initial configuration after deformat
39、ion3.5active surface areasurface area of copper in the IUD that is intended to come into contact with uterine fluids4 Intended performance4.1 GeneralISO 14630:2012, Clause 4, shall apply.4.2 Clinical performanceAn IUD shall meet the following requirements for a period of five years (the minimum inte
40、nded lifetime of use): the upper limit of the 95 % confidence level, two-sided confidence interval for the one-year pregnancy rate computed using life table methods shall be 2 %; one-year expulsion rates computed using life table methods shall be 10 %; one-year discontinuation rates computed using l
41、ife table methods shall be 35 %.5 Design attributes5.1 GeneralISO 14630:2012, Clause 5, shall apply.Thread and 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 a way as to minimiz
42、e the risk of perforation and subsequent bowel obstruction. The IUD and insertion instruments shall not exhibit 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 be 36,2 mm; the no
43、minal width of an IUD shall be 32,3 mm.When determined as specified in 7.2.1, the dimensions shall be consistent with the specifications as given by the manufacturer within tolerances of 5 %.5.3.2 Copper componentsThe nominal active surface area of copper shall be at least 200 mm2but shall not be la
44、rger than 380 mm2. If copper wire is used, the nominal diameter of the copper wire shall be at least 0,25 mm.6DIN EN ISO 7439:2015-08 EN ISO 7439:2015 (E) The diameter shall be consistent with the specifications given by the manufacturer within tolerances of 5 % and the active surface area within to
45、lerances 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.5.3.4 Insertion instrumentThe maximum nominal outer width of that part of an insertion instrument intended to come into contact with the cervical canal shall not be greater t
46、han 5 mm.The dimensions shall be consistent with the specifications 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 as given in Table 1.Table 1 Tensile force of IUDsIUD typeTensile
47、forceNT-shaped devices 9,5All other devices 125.5 Stability5.5.1 Shelf-life stabilityThe IUD shall meet any performance specification given by the manufacturer based on in vitro studies for the complete duration of the declared shelf life.5.5.2 In situ stabilityDuring the length of the intended peri
48、od of use, the frame, together with copper components, shall retain structural integrity and the entire IUD shall withstand the tensile force in accordance with 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 sha
49、ll be such that the residual deformation does not exceed 5 mm.5.7 In situ detectionAll parts of the IUD frame shall be detectable by X-ray examination. If barium sulfate is used in the plastics components as the opaque material, its content shall range from 15 % (mass fraction) to 25 % (mass fraction), when tested in accordance with 7.5.6 MaterialsISO 14630:2012, Clause 6, shall apply.The plastics body, including the substance conferring r
