BAS EN ISO 14971:2013
Medical devices - Application of risk management to medical devices
General Information
Status: Withdrawn
No. of pages: 98
Language: English
Edition: 4.
Adoption method: Endorsment
Publication date: 21.11.2013
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
ISO 14971:2007 specifies 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.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Lifecycle
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Original document and degree of correspondence
- EN ISO 14971:2012, identical
- ISO 14971:2007, identical