CEN TR 17223-2018 Guidance on the relationship between EN ISO 13485 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical .pdf
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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Guidance on the relationship between EN ISO 13485: 2016 (Medical devices Quality management systems Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices R
2、egulationPD CEN/TR 17223:2018TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 17223 March 2018 ICS 03.100.70; 11.040.01English versionGuidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and Europea
3、n Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation Document dorientation sur la relation entre lEN ISO13485: 2016 (Dispositifs mdicaux - Systmes de management de la qualit - Exigences des finsrglementaires) et le Rglement europen relatif auxdispositifs mdicaux ainsi que
4、le Rglement relatif auxdispositifs mdicaux de diagnostic in vitro Leitfaden zum Zusammenhang zwischen EN ISO13485: 2016 (Medizinprodukte - Qualittsmanagementsysteme - Anforderungen frregulatorische Zwecke) und den europischen Verordnungen ber Medizinprodukte und In-vitro-Diagnostika This Technical R
5、eport was approved by CEN on 12 February 2018. It has been drawn up by the Technical Committee CEN/CLC/JTC 3.CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, F
6、ormer Yugoslav Republic of Macedonia, France, Germany,Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.CEN-CENELEC Management Centre:Rue de
7、 la Science 23, B-1040 Brussels 2018 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and forCENELEC Members.Ref. No. CEN/TR 17223:2018 ENational forewordThis Published Document is the UK implementation of CEN/TR 17223:2018.The UK partic
8、ipation in its preparation was entrusted to Technical Committee CH/210, Quality management and corresponding general aspects for medical devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the nece
9、ssary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 51912 3ICS 03.100.70; 11.040.01Compliance with a British Standard cannot confer immunity from legal obligations.This Publish
10、ed Document was published under the authority of the Standards Policy and Strategy Committee on 31 March 2018.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN/TR 17223:2018TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 17223 March 2018 ICS 03.10
11、0.70; 11.040.01 English version Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation Document dorientation sur la relati
12、on entre lEN ISO 13485: 2016 (Dispositifs mdicaux - Systmes de management de la qualit - Exigences des fins rglementaires) et le Rglement europen relatif aux dispositifs mdicaux ainsi que le Rglement relatif aux dispositifs mdicaux de diagnostic in vitro Leitfaden zum Zusammenhang zwischen EN ISO 13
13、485: 2016 (Medizinprodukte - Qualittsmanagementsysteme - Anforderungen fr regulatorische Zwecke) und den europischen Verordnungen ber Medizinprodukte und In-vitro-Diagnostika This Technical Report was approved by CEN on 12 February 2018. It has been drawn up by the Technical Committee CEN/CLC/JTC 3.
14、 CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lit
15、huania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN/CENELEC All rights of exploitation in any form and by any means
16、reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. CEN/TR 17223:2018 EPD CEN/TR 17223:2018CEN/TR 17223:2018 (E) 2 Contents Page European Foreword . 3 Introduction . 4 1 Scope . 7 2 Normative references. 7 3 Terms and definitions 7 4 Relationship between the European Regula
17、tions for Medical Devices and in vitro Diagnostic Medical Devices and the clauses of EN ISO 13485 . 7 PD CEN/TR 17223:2018CEN/TR 17223:2018 (E) 3 European Foreword This document (CEN/TR 17223:2018) has been prepared by Technical Committee CEN/CLC/JTC 3, “Quality management and corresponding general
18、aspects for medical devices”, the secretariat of which is held by NEN. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. PD CEN/TR 17223:2018CEN/TR 172
19、23:2018 (E) 4 Introduction This Technical Report has been prepared to provide guidance on the relationship between EN ISO 13485:2016 (Medical devices Quality management systems Requirements for regulatory purposes) and the requirements in the European Regulations on Medical Devices (MDR)- Regulation
20、 (EU) 2017/745 - and in vitro Diagnostic Medical Devices (IVDR) -Regulation (EU) 2017/746. EN ISO 13485 describes a quality management system that is applicable to medical devices and is intended for regulatory purposes. The European Regulations for medical devices and EN ISO 13485 present holistic
21、requirements for systematic application of a process approach to quality management into which an organization can incorporate regulatory requirements that are applicable to its activities. As the requirements are integrated and build on each other, all the requirements applicable to the organizatio
22、ns activities and the applicable regulatory requirements need to be applied. It is not intended that requirements are implemented in isolation from the complete system. While this Technical Report describes the interrelationship of individual paragraphs, or parts of a paragraph, of the Regulations w
23、ith particular subclauses of EN ISO 13485, this is not intended to imply that these subclauses can be implemented in the absence of the entire quality management system described in the standard. This Technical Report focuses on the general obligations of the manufacturer (Article 10) and the confor
24、mity assessment requirements (Annexes IX and XI) of the European Regulations for Medical Devices and in vitro Diagnostic Medical Devices. Compliance with all the normative clauses in EN ISO 13485 will ensure that a process is in place to address quality management system aspects related to medical d
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