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Publication details

Publication CODE Title
IEC 82304-1:2016 (2016-10) HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY
 
Price Excl. VAT Total number of pages, tables and drawings
201.00 € 55 P..
Description
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.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2016-10-27
ICS-Code (International Standards Classification) 35.240.80
NBN Status New
IEC publication date 2016-10-27
IEC stability date 2022-12-31
IEC file modification date 2016-10-27
IEC last modification date 2019-10-31