CR 14060:2000
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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
07-03-2023
22-11-2000
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Withdrawn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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