99/563585 DC : DRAFT JULY 1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
EN ISO 14971 - MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
03-15-2001
11-23-2012
Defines a procedure for manufacturers to identify the hazards concerned with medical devices and accessories, including in vitro diagnostic devices, to evaluate and estimate and control the risks, and monitor the control effectiveness. Applies to all stages of a medical device';s lifestyle, but not to clinical judgements regarding its use or to acceptable risk levels.
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