1、BSI Standards PublicationCardiovascular implants and extracorporeal systems Vascular device-drug combination productsPart 1: General requirementsBS EN ISO 12417-1:2015National forewordThis British Standard is the UK implementation of EN ISO 12417-1:2015. Itsupersedes DD ISO/TS 12417:2011 which is wi
2、thdrawn.The UK participation in its preparation was entrusted by TechnicalCommittee CH/150, Implants for surgery, to Subcommittee CH/150/2,Cardiovascular implants.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to inc
3、lude all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 76395 3ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This Bri
4、tish Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 12417-1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12417-1 October 2015 ICS 11.
5、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 combinaison mdicament-dispositif vasculaire - Partie 1: Exigence
6、s 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 on 8 August 2015. CEN members are bound to comply with the CE
7、N/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 Ce
8、ntre 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 t
9、he 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, Nethe
10、rlands, 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 Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All righ
11、ts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 12417-1:2015 EBS EN ISO 12417-1:2015EN ISO 12417-1:2015 (E) 2 Contents Page European foreword . 3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirem
12、ents of EU Directive 93/42/EEC on medical devices 4 BS EN ISO 12417-1:2015EN ISO 12417-1:2015 (E) 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 surgic
13、al 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 latest by April 2016, and conflicting national standards shall be withdrawn at the latest by April 2016.
14、 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 such patent rights. This document has been prepared under a mandate given to CEN by the European Commissi
15、on and the European Free Trade Association, and supports essential requirements of EU Directive(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
16、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, Lithuania, Luxembourg, Malta, Nethe
17、rlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, 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. BS EN ISO 12417-1:2015EN ISO 12417-1:2015 (E) 4 Annex ZA
18、 (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of confor
19、ming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of
20、 this standard confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. This standard provides a process for managing risks associated with medical devices. Because this stan
21、dard describes an ongoing process applicable in part or in all to the Essential Requirements of Directive 93/42/EEC on medical devices, it is not meaningful to link individual clauses of the standard to specific corresponding Essential Requirements. Compliance with all the requirement clauses in thi
22、s standard will ensure that general aspects of medical devices related to patient risk and safety have been addressed. For particular medical devices or for particular safety aspects, additional specific requirements may need to be complied with in order to meet the essential requirements. With resp
23、ect to users of medical devices and third persons, additional specific requirements from other EU Directives may need to be complied with in order to meet Essential Requirement 1. Relevant harmonized standards may also be used for these purposes. The risk management processes described in this stand
24、ard could establish the need for collection of clinical or other experimental data for risk-benefit evaluation purposes. It does not describe how this has to be carried out. Relevant harmonized standards may be used for this purpose. WARNING Other requirements and other EU Directives may be applicab
25、le to a product falling within the scope of this standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC amended by Directive 2007/47/EEC Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN ISO 12417-1 Qualifying remarks 7.1 Claus
26、e 5 Clause 8 7.2 Clause 8 9.3 Clause 10 7.3 7.2.4.3 7.2.4.3.2 7.2.4.3.2 g) 7.2.4.3.5 BS EN ISO 12417-1:2015EN ISO 12417-1:2015 (E) 5 Essential Requirements (ERs) of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN ISO 12417-1 Qualifying remarks 7.4 7.2.4.3 7.2.4.3.4 7.2.4.3.10 7.2.4.3.12 7.2.4
27、.3.13 7.5 7.2.4.3.4 7.2.4.3.10 7.2.4.3.11 7.2.4.3.16 9.3 7.6 5.2.3 f) 8.1 Clause 9 Clause 10 8.3 (Design) 5.1 7.2.4.2 8.3 (Manufacturing, Packaging) Clause 8 Clause 9 10.1 10.2 11.2 m) 8.4 9.1.1 8.5 8.1 9.2 8.6 9.2 Clause 10 8.7 Clause 11 EN ISO 14630:2012, 11.2 f) 9.1 5.1 a) 5.2.3 e) 7.2.4.3.10 See
28、 specific standards product requirements for the device part 9.2 (Risk of injury) 5.1 7.2.4.1 9.2 (Magnetic fields) 5.2.2 f) 5.2.3 g) 7.2.4.3.7 9.2 (Aging) 5.2.1 e) 5.2.2 a) 7.1 7.2.4.3.10 9.3 11.2.1 l) BS EN ISO 12417-1:2015EN ISO 12417-1:2015 (E) 6 Essential Requirements (ERs) of Directive 93/42/E
29、EC Clause(s)/sub-clause(s) of this EN ISO 12417-1 Qualifying remarks 13.1 11.2.1 i) 11.3 13.2 Clause 11 13.3 a) 11.2.1 b) 13.3 b) 11.2.1 a), c), d) 13.3 c) 11.2.1 f) 13.3 d) 11.2.1 e) 13.3 e) 11.2.1 h) 13.3 f) 11.2.1 g) 13.3 i) 11.2.1 k) 13.3 j) 11.2.1 i) 13.3 k) 11.2.1 j) 13.3 l) 11.2.1 l) 13.3 m)
30、11.2.1 f) 13.4 11.3 a), d) 13.5 Clause 11 13.6 a) 11.3 13.6 b) 11.3 e), g), j), k), r) 13.6 c) N/A See EN ISO 14630, 11.3 f) 13.6 e) 11.2 b), e), i), j), k), m) 13.6 f) 11.3 j) 13.6 g) 11.3 o), q) 13.6 l) 11.3 j) 13.6 m) 11.3 a), b), c), f) 13.6 n) 11.3 k) 13.6 q) 11.3 t) BS EN ISO 12417-1:2015ISO 1
31、2417-1:2015(E)Foreword vIntroduction vi1 Scope . 12 Normative references 23 Terms and definitions . 24 Intended performance . 64.1 General . 64.2 Classification . 64.3 Intended clinical location . 65 Design attributes 65.1 General . 65.2 Drug-containing part of the VDDCP (DCP) . 75.2.1 General 75.2.
32、2 Matrix 75.2.3 Active pharmaceutical ingredient (API) 76 Materials . 87 Design evaluation 87.1 General . 87.2 Pre-clinical evaluation 97.2.1 Sampling 97.2.2 Conditioning of test samples . 97.2.3 Pre-Clinical in vitro test reports and additional information . 107.2.4 Pre-clinical in vitro evaluation
33、 . 107.2.5 Preclinical in vivo evaluation . 167.3 Clinical evaluation . 217.3.1 Purpose . 217.3.2 Specific aims . 217.3.3 Clinical investigation plan . 217.3.4 Data acquisition .227.3.5 Final report 247.4 Post-market surveillance 258 Manufacturing 258.1 General 258.2 Raw material reporting and analy
34、sis of the API 258.3 Raw material analysis and reporting for excipients 268.4 VDDCP batch release testing 279 Sterilization 279.1 Products supplied sterile 279.1.1 Testing to support “Sterile” labelling 279.2 Products supplied non-sterile. 279.3 Sterilization residuals 2710 Packaging 2710.1 General
35、2710.2 Considerations for VDDCPs . 2810.3 Impact of changes in storage and shipping temperatures on VDDCP 2811 Information supplied by the manufacturer 2811.1 General 2811.2 Labelling 2811.2.1 VDDCP label(s) . 2811.2.2 Record label . 29 ISO 2015 All rights reserved iiiContents PageBS EN ISO 12417-1:
36、2015ISO 12417-1:2015(E)11.3 Instructions for use (IFU) . 29Annex A (informative) Definitions of potential clinical and technical events 31Annex B (informative) Local information regarding submission issues for VDDCPs .36Bibliography .43iv ISO 2015 All rights reservedBS EN ISO 12417-1:2015ISO 12417-1
37、:2015(E)ForewordISO (the International Organization 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 wh
38、ich a technical committee has been established 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
39、matters of electrotechnical standardization.The procedures used to develop this document and 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
40、 document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.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 a
41、ll such patent rights. Details of any patent rights identified during the development of the document 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 an
42、d does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions 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 in
43、formationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee 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 c
44、ombination products: Part 1: General requirements Part 2: Local regulatory guidance ISO 2015 All rights reserved vBS EN ISO 12417-1:2015ISO 12417-1:2015(E)IntroductionThis part of ISO 12417 was prepared in order to provide minimum requirements for vascular device-drug combination products (VDDCPs).O
45、nly issues related to vascular devices combined with drug(s), wherein the drug serves an ancillary function of the VDDCP 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 te
46、chnologies will need to be evaluated following the basic requirements of this International Standard. Testing beyond the 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 t
47、he performance in deciding what testing will be appropriate.For issues related to the primary mode of action (PMOA) of the vascular VDDCP, the reader might find it useful to consider a number of other International Standards (see Bibliography).vi ISO 2015 All rights reservedBS EN ISO 12417-1:2015Car
48、diovascular implants and extracorporeal systems Vascular device-drug combination products Part 1: General requirements1 ScopeThis part of ISO 12417 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical dev
49、ices 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, drug 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, desi
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