01/564216 DC : DRAFT OCT 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
DRAFT AMENDMENT 1 TO BS EN ISO 14971 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
07-07-2003
11-23-2012
Foreword
Introduction
Annex H
H.1 Introduction
H.2 Rationale for requirements in particular clauses
and subclauses
H.2.1 Scope
H.2.2 Terms and definitions
H.2.3 General requirements for risk management
H.2.4 Risk analysis
H.2.5 Risk Evaluation
H.2.6 Risk Control
H.2.7 Overall residual risk evaluation
H.2.8 Risk Management report
H.2.9 Post-production information
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