IEC 82304-1:2016 applies to the safety and security 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. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
Document identifier
IEC 82304-1 Ed. 1.0 b:2016
Title
Health software - Part 1: General requirements for product safety
IEC Category
SC 62A: Common aspects of electrical equipment used in medical practice
Publication date
2016-10-27
International Relationship
| Price |
199 vnd |
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