IEC 82304-1:2016

Published (Edition 1, 2016)

This publication was last reviewed and confirmed in 2021. Therefore this version remains current.

IEC 82304-1:2016

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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.

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Medical devices - the basics

This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

ISO 13485:2016
ISO 13485:2016 A practical guide
ISO 14971:2019
ISO/TR 24971:2020

English | PDF

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ISO/TS 82304-2

Health software

Part 2: Health and wellness apps — Quality and reliability

Published in 2021

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General information

Status
: Published

Publication date
: 2016-10

Stage
: International Standard confirmed [90.93]
Edition
: 1

Number of pages
: 45
Technical Committee :
ISO/TC 215

ICS :
35.080 35.240.80
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