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: Latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2008-09-01

Latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-12-01

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.

Endorsement notice

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

Introduction

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.

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.

Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

NOTE Informative references are listed in the bibliography beginning on page 96.

ISO 14971:2007, Medical devices. Application of risk management to medical devices