Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

Publisher:
Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

Provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software. It does this in the context of ISO 14971:2007, Medical devices - Application of risk management to medical devices and in the context of ISO/IEC 62304:2006, Medical device software - Software life cycle processes.

ANSI :	ANSI Approved
File Size :	1 file , 710 KB
ISBN(s) :	1570203717
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	80
Published :	09/03/2009

AAMI/IEC TIR80002-1:2009 PDF

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

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