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IEC 82304-1:2016 (EN-FR)

Health software - Part 1: General requirements for product safety

Standard Details

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.

General Information

Status : ACTIVE
Standard Type: Main
Document No: IEC 82304-1:2016 (EN-FR)
Document Year: 2016
Pages: 55
Edition: 1.0
  • Section Volume:
  • TC 62.SC 62A Common aspects of electrical equipment used in medical practice
  • ICS:
  • 35.240.80 IT applications in health care technology

Life Cycle

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ACTIVE
IEC 82304-1:2016 (EN-FR)
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