Skip to main content
Back

EVS-EN 82304-1:2017

Health Software - Part 1: General requirements for product safety

General information

Valid from 18.09.2017
Base Documents
IEC 82304-1:2016; EN 82304-1:2017
Directives or regulations
None

Standard history

Status
Date
Type
Name
18.09.2017
Main

EN 82304-1 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. It is intended for manufacturers and it covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

For health software that can contribute to a hazardous situation, risk control is needed to prevent harm or reduce the likelihood of harm occurring. Testing of the finished product is not, by itself, adequate to address the safety of health software. Therefore, requirements for the processes by which the health software is developed are necessary.

EN 82304-1 also applies to health software products like medical apps or health apps intended to be used in combination with mobile computing platforms.

The international standard has been approved in Europe as EN 82304-1:2017 without any changes.

Required fields are indicated with *

*
*
*
PDF
24.40 € incl tax
Paper
24.40 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main + amendment

EVS-EN 62304:2006+A1:2015

Medical device software - Software life-cycle processes
Newest version Valid from 15.11.2019
Main + amendment

EVS-EN 62366-1:2015+A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + IEC 62366-1:2015/A1:2020)
Newest version Valid from 17.08.2020
Main

CEN ISO/TS 82304-2:2021

Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021)
Newest version Valid from 01.09.2021
Main + amendment

EVS-EN ISO 14971:2019+A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Newest version Valid from 15.12.2021