IEC 82304 Health Software

GPTKB entity

Statements (23)
Predicate Object
gptkbp:instanceOf gptkb:standard
gptkbp:appliesTo standalone software
health IT systems
gptkbp:covers risk management
product safety
lifecycle requirements
product security
gptkbp:focusesOn health software
gptkbp:fullName gptkb:IEC_82304_Health_Software_–_General_requirements_for_product_safety
https://www.w3.org/2000/01/rdf-schema#label IEC 82304 Health Software
gptkbp:language English
gptkbp:publishedBy gptkb:International_Electrotechnical_Commission
gptkbp:relatedTo gptkb:IEC_62304
gptkbp:releaseDate 2016
gptkbp:scope safety and security of health software products
gptkbp:standardNumber gptkb:IEC_82304-1
gptkbp:status active
gptkbp:targetAudience healthcare providers
regulators
manufacturers of health software
gptkbp:usedIn medical device software development
gptkbp:bfsParent gptkb:IEC_82304
gptkbp:bfsLayer 6