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CEN - EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

active, Most Current
Organization: CEN
Publication Date: 1 March 2016
Status: active
Page Count: 68
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Medical equipment in general): 11.040.01
scope:

European foreword

This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" the secretariat of which is held by NEN.

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of an identical text or by endorsement, at the latest by September 2016, and conflicting national standards shall be withdrawn at the latest by March 2019.

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 supersedes EN ISO 13485:2012.

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 Directives.

For relationship with EU Directives, see informative Annex ZA, ZB and ZC, which are integral parts 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, 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, Turkey and the United Kingdom.

The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, ZB and ZC, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below.

NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply.

Document History

EN ISO 13485
March 1, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
European foreword This document (EN ISO 13485:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaboration...
February 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
A description is not available for this item.
February 1, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
July 24, 2003
Medical devices Quality management systems Requirements for regulatory purposes
A description is not available for this item.
July 24, 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
November 1, 2000
Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001
A description is not available for this item.

References

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