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CR 14060:2000

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

Medical device traceability

Withdrawn date

07-03-2023

Superseded by

CEN/CLC/TR 14060:2014

Published date

22-11-2000

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Foreword
Introduction
1 Scope
2 Definition
3 The Distribution Chain
4 Traceability/review of the concept
Bibliography

This technical report provides recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market.It is understood that the procedures to be described in this report will be more detailed in relation to high-risk devices when the need has been identified to trace devices as far as the actual patient. For lower risk devices this report provides recommendations for elements of procedures to be transmitted by manufacturers to the members of a distribution chain, to achieve an appropriate level of traceability, perhaps of batches of products in some cases, sufficient to withdraw or inform purchasers or users of information regarding such identified products.

Committee
CEN/CLC/JTC 3
DocumentType
Report
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
SupersededBy

Standards Relationship
NEN NPR CR 14060 : 2000 Identical
S.R. CR 14060:2000 Identical
SN CR 14060 : 2001 Identical
UNE-CR 14060:2001 Identical

DIN EN ISO 14607:2009-08 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
ISO 14607:2007 Non-active surgical implants Mammary implants Particular requirements
UNI EN ISO 14607 : 2009 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS
BS EN ISO 14607:2009 Non-active surgical implants. Mammary implants. Particular requirements
I.S. EN ISO 14607:2009 NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018)
EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002

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