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AAMI ISO TIR 24971 : 2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971
Available format(s)

Hardcopy , PDF

Superseded date

06-19-2020

Language(s)

English

Published date

01-01-2016

Glossary of equivalent standards
Committee representation
Background of US adoption of ISO/TS 24971:2013
Foreword
Introduction
1 Scope
2 The role of international product safety and process
  standards in risk management
3 Developing the policy for determining the criteria for
  risk acceptability
4 Production and post-production feedback loop
5 Differentiation of information for safety and disclosure
  of residual risk
6 Evaluation of overall residual risk

Specifies guidance in addressing specific areas of ISO 14971 when implementing risk management.

DocumentType
Standard
Pages
29
ProductNote
Reconfirmed 2013
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO/TR 24971:2013 Identical

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