BS EN ISO 12417-1-2015 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products General requirements《心血管植入物和体外系统 血管装置药物并用产品 一般要求》.pdf
《BS EN ISO 12417-1-2015 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products General requirements《心血管植入物和体外系统 血管装置药物并用产品 一般要求》.pdf》由会员分享,可在线阅读,更多相关《BS EN ISO 12417-1-2015 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products General requirements《心血管植入物和体外系统 血管装置药物并用产品 一般要求》.pdf(64页珍藏版)》请在麦多课文档分享上搜索。
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
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