UNE-EN 82304-1:2017

1.1Purpose

This International Standard applies to the SAFETY 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.

1.2Field of application

This standard covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS.

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;

c)implantable devices covered by the ISO 14708 series

NOTE This standard also applies to HEALTH SOFTWARE PRODUCTS (e.g., medical apps, health apps) intended to be used in combination with mobile computing platforms.

1.3Compliance

Compliance with this standard is determined by inspection of all documentation required by this standard.

Assessment of compliance is carried out by the MANUFACTURER and documented as part of the ACCOMPANYING DOCUMENTS.

Where the HEALTH SOFTWARE PRODUCT is subject to regulatory requirements, external assessment of all documentation required by this standard is possible.

Where this standard normatively references parts or clauses of other standards focused on SAFETY, the MANUFACTURER may use alternative methods. Provided it can be demonstrated that the process results of such alternative methods are equivalent including traceability and the RESIDUAL RISK remains acceptable, these alternative methods are considered acceptable to demonstrate conformity with this standard.

NOTE The term conformance is used in ISO/IEC 12207 where the term compliance is used in this standard.