CR 14060:2000

Medical device traceability

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.

Sledljivost medicinskih pripomočkov

General Information

• Status: Withdrawn
• Publication Date: 21-Nov-2000
• Withdrawal Date: 02-Dec-2014
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/SS S99 - Health, environment and medical equipment - Undetermined
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 03-Dec-2014
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST CR 14060:2001 - Medical device traceability

Relations

• Replaced By: CEN/CLC/TR 14060:2014 - Medical device traceability enabled by unique device identification (UDI)
• Effective Date: 10-Dec-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2001
6OHGOMLYRVWPHGLFLQVNLKSULSRPRþNRY
Medical device traceability
Ta slovenski standard je istoveten z: CR 14060:2000
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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