Standards Council of Canada

Health software -- General requirements for product safety

IEC/DIS 82304-1, Health software -- Part 1: General requirements for product safety

Committee: ISO/TC 215

Comment Period Closes: 2015-10-06

This International Standard applies to the SAFETY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS. 

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