EN ISO 7439-2015 en Copper-bearing contraceptive intrauterine devices - Requirements and tests《含铜的子宫内避孕器具 要求和试验(ISO 7439 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 7439:2015Copper-bearing contraceptiveintrauterine devices Requirements and testsBS EN ISO 7439:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 7439:2015.It supersedes BS EN ISO 7439:2011 which is withdrawn.The UK parti

2、cipation in its preparation was entrusted to TechnicalCommittee CH/157, Mechanical contraceptives.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are respons

3、ible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 86139 0ICS 11.200Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Polic

4、y and Strategy Committee on 30 April 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7439 April 2015 ICS 11.200 Supersedes EN ISO 7439:2011English Version Copper-bearing contraceptive intrauterine devices - Requirements and tests (IS

5、O 7439:2015) Dispositifs 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 c

6、omply with the CEN/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-CENE

7、LEC Management Centre 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

8、 same status as the 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, Luxembo

9、urg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

10、 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7439:2015 EBS EN ISO 7439:2015EN ISO 7439:2015 (E) 3 Foreword This document (EN ISO 7439:2015) has been prepared by Technical Committee ISO/TC 157 “Non-systemic contraceptiv

11、es 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 Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the late

12、st 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 of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all s

13、uch 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 Free Trade Association, and supports essential requirements of EU Directive. According to the CEN-CENELEC Internal Regulations, the n

14、ational standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

15、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 7439:2015 has been approved by CEN as EN ISO 7439:2015 without any modification. BS EN ISO 7439:2015ISO 7439

16、:2015(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Intended performance . 24.1 General . 24.2 Clinical performance 25 Design attributes 25.1 General . 25.2 Shape . 25.3 Dimensions . 25.3.1 IUD . 25.3.2 Copper components 25.3.3 Thread . 35.3.4 Insertion i

17、nstrument 35.4 Tensile force. 35.5 Stability 35.5.1 Shelf-life stability . 35.5.2 In situ stability 35.6 Visco-elastic property . 35.7 In situ detection . 36 Materials . 37 Design evaluation 47.1 General . 47.2 Determination of dimensions 47.3 Determination of tensile force . 47.3.1 Principle 47.3.2

18、 Apparatus . 47.3.3 Procedure . 47.3.4 Test report . 47.4 Test of visco-elastic property (memory test) . 57.4.1 Principle 57.4.2 Procedure . 57.4.3 Test report . 57.5 Determination of barium sulfate content and identification of barium and sulfate . 57.5.1 Ash content test 57.5.2 Identity test 57.6

19、Pre-clinical evaluation 67.7 Clinical evaluation 68 Manufacturing and inspection . 79 Sterilization . 710 Packaging . 711 Information to be supplied by the manufacturer . 811.1 General . 811.2 Labelling of the primary container 811.3 Labelling of the secondary container 811.4 Instructions for use .

20、811.5 Information intended for the woman 9 ISO 2015 All rights reserved iiiContents PageBS EN ISO 7439:2015ISO 7439:2015(E)Bibliography .11iv ISO 2015 All rights reservedContents PageBS EN ISO 7439:2015ISO 7439:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide fe

21、deration 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 com

22、mittee. 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.The procedures used to develop this document a

23、nd those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Pa

24、rt 2. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the doc

25、ument will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expre

26、ssions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and S

27、TI barrier prophylactics.This third edition cancels and replaces the second edition (ISO 7439:2011), of which it constitutes a minor revision. ISO 2015 All rights reserved vBS EN ISO 7439:2015ISO 7439:2015(E)IntroductionAlthough every foreign object in the uterus exhibits a certain contraceptive eff

28、ect, the method by which copper-bearing contraceptive intrauterine 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.T

29、he effectiveness of copper-bearing IUDs is many times greater 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 concer

30、ning medical devices.Contraceptive IUDs whose primary purpose 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 relatin

31、g 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. It is advisable that significant changes in the design of the IUD, insertion device, specification or insertion tec

32、hnique be validated.vi ISO 2015 All rights reservedBS EN ISO 7439:2015Copper-bearing contraceptive intrauterine devices Requirements and tests1 ScopeThis International Standard specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their inserti

33、on instruments.It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.NOTE Some aspects of this International Standard can be applicable to medicated intrauterine devices and IUDs not containing copper.2 Normative referencesThe following d

34、ocuments, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1, Biological

35、 evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirementsISO 14630:2012, Non-active surgical implants General requirementsISO 14971, Medical devices Application

36、of risk management to medical devicesISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsEuropean Pharmacopoeia (Ph. Eur.)1)3 Terms and definitionsFor the purposes of this document, the following terms and d

37、efinitions apply.3.1contraceptive intrauterine deviceIUDcopper-bearing device placed in the uterine cavity for the purpose of preventing pregnancy3.2insertion instrumentinstrument designed to place an IUD in the uterine cavity3.3threadattachment to an IUD for the purposes of verifying the presence a

38、nd 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 the device is placed correctly in the uterine cavity.1) European Directorate for the Quality of Medicines (EDQM) of the Council of Europe.INTERNATIONAL STANDARD ISO

39、7439:2015(E) ISO 2015 All rights reserved 1BS EN ISO 7439:2015ISO 7439:2015(E)3.4visco-elastic propertyproperty of an IUD enabling an approximate return to its initial configuration after deformation3.5active surface areasurface area of copper in the IUD that is intended to come into contact with ut

40、erine 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 intended lifetime of use): the upper limit of the 95 % confidence level, two-sided confidence interval for t

41、he 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 life table methods shall be 35 %.5 Design attributes5.1 GeneralISO 14630:2012, Clause 5, shall apply.Thre

42、ad 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 minimize the risk of perforation and subsequent bowel obstruction. The IUD and insertion instruments shall not

43、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 nominal width of an IUD shall be 32,3 mm.When determined as specified in 7.2.1, the dimensions shall be co

44、nsistent 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 larger than 380 mm2. If copper wire is used, the nominal diameter of the copper wire shall be at least 0,2

45、5 mm.2 ISO 2015 All rights reservedBS EN ISO 7439:2015ISO 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 tolerances of 10 %.5.3.3 ThreadWhen determined in accordance with 7.2.2, the length of

46、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 than 5 mm.The dimensions shall be consistent with the specifications given by the manu

47、facturer 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 forceNT-shaped devices 9,5All other devices 125.5 Stability5.5.1 Shelf-life stability

48、The 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 period of use, the frame, together with copper components, shall retain structural integr

49、ity 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 shall 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 t