FOREWORD

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International Standard IEC 82304‑1 has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice, and ISO technical committee 215: Health informatics.

It is published as a double logo standard.

The text of this standard is based on the following documents of IEC:

FDIS	Report on voting
62A/1140/FDIS	62A/1151/RVD

Full information on the voting for the approval of this part of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 21 P members out of 22 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

Terms defined in Clause 3 of this standard are printed in small capitals.

For the purposes of this standard:

— “shall” means that compliance with a requirement is mandatory for compliance with this standard;
— “should” means that compliance with a requirement is recommended but is not mandatory for compliance with this standard;
— “may” is used to describe a permissible way to achieve compliance with a requirement; and
— “establish” means to define, document, and implement.

An asterisk (* ) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.

The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific publication. At this date, the publication will be

• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of National Committees is drawn to the fact that manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC or ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

BS EN 82304-1:2017

Health Software - General requirements for product safety

Current

Published:

31 Dec 2017