UNI EN ISO 14971 : 2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
03-22-2010
01-01-2008
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
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
Annex ZA (informative) - Relationship between this European Standard
and the Essential Requirements of EU Directives 93/42/EEC
Medical Devices, 90/385/EEC Active Implantable Medical
Devices and 98/79/EC In Vitro Diagnostic Devices
Bibliography
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