ДСТУ EN ISO 14971:2015 Изделия медицинские. Руководство по управлению риском (EN ISO 14971:2012, IDT; ISO 14971:2007, IDT)
ДСТУ EN ISO 14971:2015
(EN ISO 14971:2012, IDT; ISO 14971:2007, IDT)
Вироби медичні. Настанови щодо управління ризиком
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)
Contents
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
Bibliography
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