National foreword

This British Standard is the UK implementation of EN 62366:2008+A1:2015. It is identical to IEC 62366:2007, incorporating amendment 1:2014. It supersedes BS EN 62366:2008, which will be withdrawn on 14 April 2018.

The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.

A list of organizations represented on this subcommittee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2008

Foreword

The text of document 62A/574/FDIS, future edition 1 of IEC 62366, prepared by a joint working group of subcommittee 62A: Common aspects of electrical medical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice and ISO/TC 210, Quality management and corresponding general aspects for medical devices, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62366 on 2007-12-01.

The following dates were fixed:

This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directives MDD (93/42/EEC) and IVD (98/79/EC). See Annex ZZ.

In this 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 in Clause 3 or as noted: small capitals.

Annexes ZA and ZZ have been added by CENELEC.

Endorsement notice

The text of the International Standard IEC 62366:2007 was approved by CENELEC as a European Standard without any modification.

Foreword to amendment 1

The text of document 62A/889/FDIS, future IEC 62366:2007/A1, prepared by SC 62A "Common aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in medical practice" and ISO/TC 210 "Quality management and corresponding general aspects for medical devices" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62366:2008/A1:2015.

The following dates are fixed:

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 62366:2008.

This standard covers the Principle Elements of the Safety Objectives for Electrical Equipment Designed for Use within Certain Voltage Limits (LVD - 2006/95/EC).

Endorsement notice

The text of the International Standard IEC 62366:2007/A1:2014 was approved by CENELEC as a European Standard without any modification.

INTRODUCTION

Medical practice is increasingly using medical devices for observation and treatment of patients. Use errors caused by inadequate medical device usability have become an increasing cause for concern. Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn and to use. As healthcare evolves, less skilled users including patients themselves are now using medical devices and medical devices are becoming more complicated. In simpler times, the user of a medical device might be able to cope with an ambiguous, difficult-to-use user interface. The design of a usable medical device is a challenging endeavour, yet many organizations treat it as if it were just “common sense”. The design of the user interface to achieve adequate (safe) usability requires a very different skill set than that of the technical implementation of that interface.

The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use-associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is related to the risk management process as indicated in Figure A.1.

This International Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide safety in medical devices. It is intended to be useful not only for manufacturers of medical devices, but also for technical committees responsible for the preparation of particular medical device standards.

Amendment 1 updates the standard to add urgently needed requirements to deal with legacy devices where the user interface design is of unknown provenance.

1 * Scope

This International Standard specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

NOTE For the purposes of this standard, usability (see 3.17) is limited to characteristics of the user interface.

If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9), then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2).

This International Standard does not apply to clinical decision-making relating to the use of a medical device.

2 Normative references

3 Terms and definitions

4 * Principles

4.1 General requirements

4.2 * Usability engineering file

4.3 Scaling of the usability engineering effort

5 * Usability engineering process

5.1 * Application specification

5.2 * Frequently used functions

5.3 Identification of hazards and hazardous situations related to usability

5.4 Primary operating functions

5.5 * Usability specification

5.6 Usability validation plan

5.7 * User interface design and implementation

5.8 * Usability verification

5.9 * Usability validation

5.10 * User interface of unknown provenance (uoup)

6 * Accompanying document

7 * Training and materials for training

Bibliography

BS EN 62366:2008+A1:2015

Medical devices. Application of usability engineering to medical devices

Published:

30 Apr 2008

Withdrawn:

17 Jul 2018