DIN EN ISO 12417-1-2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1 General requirements (ISO 12417-1 2015) German versi.pdf

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1、February 2016 English price group 24No 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 11.040.40!%LR“2414797www.din.de

2、DIN EN ISO 12417-1Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 1: General requirements (ISO 12417-1:2015);English version EN ISO 12417-1:2015,English translation of DIN EN ISO 12417-1:2016-02Kardiovaskulre Implantate und extrakorporale Systeme Vas

3、kulre Medizinprodukt/Arzneimittel-Kombinationsprodukte Teil 1: Allgemeine Anforderungen (ISO 12417-1:2015);Englische Fassung EN ISO 12417-1:2015,Englische bersetzung von DIN EN ISO 12417-1:2016-02Implants cardiovasculaires et circuits extra-corporels Produits de combinaison mdicament-dispositif vasc

4、ulaire Partie 1: Exigences gnrales (ISO 12417-1:2015);Version anglaise EN ISO 12417-1:2015,Traduction anglaise de DIN EN ISO 12417-1:2016-02www.beuth.deDocument comprises 62 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.16

5、 DIN EN ISO 12417-1:2016-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 12417-1:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN,

6、 Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-17-01 UA Herz- und Gefimplantate. The DIN Standards corresponding to the International Standards ref

7、erred to in this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-2 DIN EN ISO 10993-2 ISO 10993-7 DIN EN ISO 10993-7 ISO 11070 DIN EN ISO 11070 ISO 11607-1 DIN EN ISO 11607-1 ISO 14155 DIN EN ISO 14155 ISO 14630 DIN EN ISO 14630 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971

8、 ISO 15223-1 DIN EN ISO 15223-1 ISO 25539-2 DIN EN ISO 25539-2 DIN EN ISO 12417-1:2016-02 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 10993-2, Biological evaluati

9、on of medical devices Part 2: Animal welfare requirements DIN EN ISO 10993-7, Biological evaluation of medical devices Ethylene oxide sterilization residuals DIN EN ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires DIN EN ISO 11607-1, Packaging for terminally sterilize

10、d medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14630, Non-active surgical implants General requirements DIN EN ISO 14937, Sterilizatio

11、n of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medica

12、l devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 25539-2, Cardiovascular implants Endovascular devices Part 2: Vascular stents DIN EN ISO 12417-1:2016-02 4 This page is intentionally blank EUROPEAN STANDARD NORM

13、E EUROPENNE EUROPISCHE NORM EN ISO 12417-1 October 2015 ICS 11.040.40 English Version Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) Implants cardiovasculaires et circuits extra-corporels -Produits de c

14、ombinaison mdicament-dispositif vasculaire - Partie 1: Exigences gnrales(ISO 12417-1:2015) Kardiovaskulre Implantate und extrakorporale Systeme - Vaskulre Medizinprodukt/Arzneimittel-Kombinationsprodukte - Teil 1: Allgemeine Anforderungen (ISO 12417-1:2015) This European Standard was approved by CEN

15、 on 8 August 2015. CEN members are bound to comply 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 m

16、ay be obtained on application to the CEN-CENELEC 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

17、 to the CEN-CENELEC Management Centre has the 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, Icelan

18、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Manageme

19、nt 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. EN ISO 12417-1:2015 EForeword 5Introduction 61 Scope . 72 Normative references 83 Terms and definitions . 84 Intended performance 124.1

20、General 124.2 Classification 124.3 Intended clinical location 125 Design attributes . 125.1 General 125.2 Drug-containing part of the VDDCP (DCP) 135.2.1 General. 135.2.2 Matrix . 135.2.3 Active pharmaceutical ingredient (API) . 136 Materials 147 Design evaluation . 147.1 General 147.2 Pre-clinical

21、evaluation . 157.2.1 Sampling. 157.2.2 Conditioning of test samples 157.2.3 Pre-Clinical in vitro test reports and additional information . 167.2.4 Pre-clinical in vitro evaluation . 167.2.5 Preclinical in vivo evaluation . 227.3 Clinical evaluation . 277.3.1 Purpose . 277.3.2 Specific aims .277.3.3

22、 Clinical investigation plan . 277.3.4 Data acquisition .287.3.5 Final report 307.4 Post-market surveillance 318 Manufacturing 318.1 General 318.2 Raw material reporting and analysis of the API 318.3 Raw material analysis and reporting for excipients 328.4 VDDCP batch release testing 339 Sterilizati

23、on 339.1 Products supplied sterile 339.1.1 Testing to support “Sterile” labelling 339.2 Products supplied non-sterile. 339.3 Sterilization residuals 3310 Packaging 3310.1 General 3310.2 Considerations for VDDCPs . 3410.3 Impact of changes in storage and shipping temperatures on VDDCP 34Contents Page

24、European foreword 4EN ISO 12417-1:2015 (E) DIN EN ISO 12417-1:2016-02 2 11.3 Instructions for use (IFU) . 35Annex A (informative) Definitions of potential clinical and technical events 37Annex B (informative) Local information regarding submission issues for VDDCPs .42Bibliography .52Annex ZA (infor

25、mative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 49 11 Information supplied by the manufacturer 3411.1 General 3411.2 Labelling 3411.2.1 VDDCP label(s) .3411.2.2 Record label .35.EN ISO 12417-1:2015 (E) DIN EN ISO 12417-1

26、:2016-02 3 European foreword This document (EN ISO 12417-1:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This European Standard shall be giv

27、en the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2016, and conflicting national standards shall be withdrawn at the latest by April 2016. Attention is drawn to the possibility that some of the elements of this document may be

28、the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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 Dir

29、ective(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium,

30、Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, 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

31、, Turkey and the United Kingdom. Endorsement notice The text of ISO 12417-1:2015 has been approved by CEN as EN ISO 12417-1:2015 without any modification. 4EN ISO 12417-1:2015 (E) DIN EN ISO 12417-1:2016-02 ForewordISO (the International Organization for Standardization) is a worldwide federation of

32、 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 committee. Int

33、ernational 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 and those in

34、tended 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, Part 2 (see w

35、ww.iso.org/directives).Attention 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 document

36、 will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any 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 expr

37、essions 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 150, Implants for surgery, Subcommitte

38、e SC 2, Cardiovascular implants and extracorporeal systems.ISO 12417 consists of the following parts under the general title, Cardiovascular implants and extracorporeal systems Vascular device-drug combination products: Part 1: General requirements Part 2: Local regulatory guidanceEN ISO 12417-1:201

39、5 (E) DIN EN ISO 12417-1:2016-02 5 IntroductionThis part of ISO 12417 was prepared in order to provide minimum requirements for vascular device-drug combination products (VDDCPs).Only issues related to vascular devices combined with drug(s), wherein the drug serves an ancillary function of the VDDCP

40、 are covered by this part of ISO 12417.It was impossible, when writing this part of ISO 12417, to take into consideration all future and emerging technologies. VDDCPs using such technologies will need to be evaluated following the basic requirements of this International Standard. Testing beyond the

41、 scope of this part of ISO 12417 might also be necessary to characterize these device systems. Consideration shall be given to the failure modes of the VDDCP and their effects on the performance in deciding what testing will be appropriate.For issues related to the primary mode of action (PMOA) of t

42、he vascular VDDCP, the reader might find it useful to consider a number of other International Standards (see Bibliography).EN ISO 12417-1:2015 (E) DIN EN ISO 12417-1:2016-02 6 1 ScopeThis part of ISO 12417 specifies requirements for vascular device-drug combination products (VDDCPs) based upon curr

43、ent technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal substance or product (drug substance, d

44、rug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action (PMOA) of the device. With regard to safety, this part of ISO 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manuf

45、acturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this International Standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This International Standa

46、rd should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539-series specifying requirements for endovascular devices. Requirements listed in this part of ISO 12417 also address VDDCPs that are not permanent implants.NOTE Due to variations in the design of

47、 combination products covered by this part of ISO 12417 and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, app

48、ropriate revision of this part of ISO 12417 might be necessary.Delivery systems or parts of the delivery system are included in the scope of this part of ISO 12417, if they comprise an integral component of the vascular device and if they are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).Devices whose PMOA is to provide a conduit for delivery of a drug, are excluded from the scope of this par