AAMI/IEC 62304:2006 PDF

Specifies life cycle processes including software development, software maintenance, software risk management, software configuration management, and software problem resolution requirements for medical device software. Also requires manufacturers to assign one of three defined safety classes to the software system, and makes normative reference to ANSI/AAMI/ISO 14971, Application of risk management to medical devices.

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ANSI :	ANSI Approved
File Size :	1 file , 1.1 MB
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	83
Published :	07/19/2006
Same As :	AAMI/IEC 62304:2006