AAMI ISO TIR 24971 : 2013 : R2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971
Hardcopy , PDF
English
01-01-2016
01-09-2021
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 |
26
|
| ProductNote |
Reconfirmed 2016
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO/TR 24971:2013 | Identical |
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