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01/564216 DC : DRAFT OCT 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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DRAFT AMENDMENT 1 TO BS EN ISO 14971 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

Superseded date

07-07-2003

Superseded by

BS EN ISO 14971:2012

Published date

23-11-2012

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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

BS EN ISO 14971

Committee
CH/5
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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