DS/IEC 82304-1:2016

Health software - Part 1: General requirements for product safety

1.1 Purpose*This Part of 82304 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.*1.2 Field of application*This document covers the entire lifecycle including design, development, VALIDATION,*installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS.*In each referenced standard, the term ômedical deviceö or ômedical device softwareö is to be*substituted by the term ôHEALTH SOFTWAREö or ôHEALTH SOFTWARE PRODUCTö, as appropriate.*Where the term ôpatientö is used, either in this document or in a referenced standard, it refers*to the person for whose health benefit the HEALTH SOFTWARE is used.*IEC 82304-1 does not apply to HEALTH SOFTWARE which is intended to become part of a*specific hardware designed for health use. Specifically, IEC 82304-1 does not apply to:*a) medical electrical equipment or systems covered by the IEC 60601/IEC 80601 series;*b) in vitro diagnostic equipment covered by the IEC 61010 series; or*c) implantable devices covered by the ISO 14708 series.*NOTE û This document also applies to HEALTH SOFTWARE PRODUCTS (e.g. medical apps, health apps) intended to be*used in combination with mobile computing platforms.*1.3 Compliance*Compliance with this document is determined by inspection of all documentation required by*this document.*Assessment of compliance is carried out and documented by the MANUFACTURER. Where the*HEALTH SOFTWARE PRODUCT is subject to regulatory requirements, external assessment may*take place.*Where this document normatively references parts or clauses of other standards focused on*SAFETY or SECURITY, the MANUFACTURER may use alternative methods to demonstrate*compliance with the requirements of this document. These alternative methods may be used if*the process results of such alternative methods, including traceability, are demonstrably*equivalent and the RESIDUAL RISK remains acceptable.*NOTE û The term ôconformanceö is used in ISO/IEC 12207 where the term ôcomplianceö is used in this document.