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EN ISO 14971-2012 medical devices - application of risk management to medical devices

Standard Number:  EN ISO 14971-2012
Title:  medical devices - application of risk management to medical devices
Language:  English
Publication Date:  2012/7/6
Execute Date:  2012/7/6
Adopted International Standard:  BS EN ISO 14971 Identical
CEI UNI EN ISO 14971 Identical
DIN EN ISO 14971
Status:  Current
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Medical equipment>>Medical equipment in general
Publisher:   European Standards(EN)
Price:  
Number of Pages:106  

Description:Describes a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.  
Catalog:Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for risk management
4 Risk analysis
5 Risk evaluation
6 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
Annex ZA (informative) - Relationship between this European
Standard and Requirements of EU Directive 93/42/EE
on Medical Devices
Annex ZB (informative) - Relationship between this European
Standard and Requirements of EU Directive
90/385/EEC on Active Implantable Medical Devices
Annex ZC (informative) - Relationship between this European
Standard and Requirements of EU Directive 98/79/EC
on In Vitro Diagnostic Medical Devices  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  290KB
Tile in English:  medical devices - application of risk management to medical devices

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