IEC 82304-1:2016

Health software — Part 1: General requirements for product safety

Publication date: Oct 31, 2016

General information

Current stage: 90.20 Effective date: Jul 15, 2026

Originator: IEC

Owner: ISO/TC 215

Type: International Standard

ICS: 35.240.80 35.080

Languages: English French

Buying

Status: Published

PDF - ALL 23,745

Paper - ALL 23,745

CD - ALL 23,745

Language

Language in which you want to receive the document.

Scope

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.

Life cycle

NOW

PUBLISHED
IEC 82304-1:2016
90.20 Standard under periodical review
Jul 15, 2026

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to create an account. If you are a member, please log in to your account by clicking on the "Log in" button.