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AAMI ISO 14971 : 2007 : R2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
Hardcopy , PDF
14-12-2019
English
01-01-2016
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 14971:2007
Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for risk management
3.1 Risk management process
3.2 Management responsibilities
3.3 Qualification of personnel
3.4 Risk management plan
3.5 Risk management file
4 Risk analysis
4.1 Risk analysis process
4.2 Intended use and identification of characteristics
related to the safety of the medical device
4.3 Identification of hazards
4.4 Estimation of the risk(s) for each hazardous situation
5 Risk evaluation
6 Risk control
6.1 Risk reduction
6.2 Risk control option analysis
6.3 Implementation of risk control measure(s)
6.4 Residual risk evaluation
6.5 Risk/benefit analysis
6.6 Risks arising from risk control measures
6.7 Completeness of risk control
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and post-production information
Annexes
Annex A (informative) Rationale for requirements
Annex B (informative) Overview of the risk management
process for medical devices
Annex C (informative) Questions that can be used to
identify medical device characteristics that
could impact on safety
Annex D (informative) Risk concepts applied to medical
devices
Annex E (informative) Examples of hazards, foreseeable
sequences of events and hazardous situations
Annex F (informative) Risk management plan
Annex G (informative) Information on risk management
techniques
Annex H (informative) Guidance on risk management for
in vitro diagnostic medical devices
Annex I (informative) Guidance on risk analysis process for
biological hazards
Annex J (informative) Information for safety and information
about residual risk
Bibliography
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