Buy I.S. EN 62366-1:2015/A1:2020

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Medical devices - Part 1: Application of usability engineering to medical devices

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Hardcopy , PDF

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English

Published date

03-09-2020

Publisher

National Standards Authority of Ireland

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€107.00

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FOREWORD
INTRODUCTION
1 * Scope
2 Normative references
3 Terms and definitions
4 Principles
5 * USABILITY ENGINEERING PROCESS
Annex A (informative) General guidance and rationale
ANNEX B (informative) Examples of possible HAZARDOUS SITUATIONS related to USABILITY
Annex C (normative) Evaluation of a USER INTERFACE OF UNKNOWN PROVENANCE (UOUP)
Annex D (informative) Types of MEDICAL DEVICE use, with examples
Annex E (informative) Reference to the essential principles
Bibliography

This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

Committee	TC 62
DocumentType	Standard
Pages	172
ProductNote	The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN 62366-1:2015/AC:2015

Standards	Relationship
IEC 62366-1:2015/AMD1:2020	Identical

Frequently Asked Questions

I.S. EN 62366-1 specifies a process for analysing, developing and evaluating medical device usability as it relates to safety. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN 62366-1 is used by medical device designers and human-factors teams managing use-related risk. It is an Irish standard published by National Standards Authority of Ireland (NSAI).

I.S. EN 62366-1 is National Standards Authority of Ireland (NSAI)'s standard for usability engineering for medical devices, while I.S. EN ISO 11137-1 covers radiation sterilisation of healthcare products (Ireland). I.S. EN 62366-1 specifies a process for analysing, developing and evaluating medical device usability as it relates to safety. I.S. EN ISO 11137-1 specifies development, validation, dose establishment or routine control requirements for radiation sterilisation.

No — I.S. EN 62366-1 is an Irish standard published by National Standards Authority of Ireland (NSAI), with its listed region as Ireland.

I.S. EN 62366-1 specifies a process for analysing, developing and evaluating medical device usability as it relates to safety. In practice it is applied by medical device designers and human-factors teams managing use-related risk.

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I.S. EN 62366-1:2015/A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices

Table of Contents

Abstract

General Product Information

International Equivalents

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