Abstract

This Uganda Standard 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. This document covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products In each referenced standard, the term medical device or medical device software is to be substituted by the term health software or health software products , as appropriate. Where the term patient 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. US 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 This document also applies to health software products (e.g. medical apps, health apps) intended to be used in combination with mobile computing platforms . This standard was published on 2022-12-13