SIST CR 14060:2001
(Main)Medical device traceability
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.
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST CR 14060:2001
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
SIST CR 14060:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST CR 14060:2001
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