FOREWORD

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International Standard IEC 62366‑1 has been prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of IEC technical committee 62: Electrical medical equipment in medical practice, and ISO technical committee 210: Quality management and corresponding general aspects for medical devices.

It is published as double logo standard.

This first edition of IEC 62366‑1, together with the first edition of IEC 62366‑2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014).

Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2019 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufacturers in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.

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

FDIS	Report on voting
62A/977/FDIS	62A/988/RVD

Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 26 P-members out of 26 having cast a vote.

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

In this International Standard, the following print types are used:

— Requirements and definitions: roman type.
— Means to assess compliance: italic type.
— Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type
— Terms defined inClause 3or as noted: small capitals.

The requirements are followed by means to assess compliance.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:

— “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;
— “should” means that compliance with a requirement or a test 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 or test.

Clauses and subclauses for which a rationale is provided in informative Annex A are marked with an asterisk (*).

A list of all parts of the IEC 62366 series, published under the general title Medical devices, can be found on the IEC website.

The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site 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 and Member Bodies is drawn to the fact that equipment 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.

The contents of the corrigendum of July 2016 have been included in this copy.

BS EN 62366-1:2015+A1:2020

Medical devices - Application of usability engineering to medical devices

Current

Published:

31 Aug 2020