Standard

IEC 82304-1:2016 ED1

Current

Existing or new amendments and versions must be purchased separately.

Language
Services

Abstract

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.

Products specifications

  • Standard from IEC
  • Published:
  • Edition: 1
  • Document type: IS
  • Pages
  • Publisher: IEC
  • Distributor: IEC
  • ICS: 35.240.80
  • International TC: TC 62/SC 62A

Product Relations

  • FRANKFURT AGREEMENT: FprEN 82304-1:2016