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ISO 7554-3:2026 Surgical instruments — Terms, measuring methods and test methods — Part 3: Test methods

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ISO 41002:2026 Facility management — Development of the facility management organization

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ISO 39004:2026 Road traffic safety — Good practice for service providers using digital platform

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ISO 82304:2016

ISO 82304:2016 Health software – Part 1: General requirements for product safety

CDN $403.00

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.

Edition

1

Published Date

2016-10-31

Status

PUBLISHED

Pages

45

Language Detail Icon

English

Format Secure Icon

Secure PDF

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.

Previous Editions

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