Medical electrical equipment General requirements for basic safety and essential performance - Collateral standard: Usability

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

05-06-2017

Publisher

Standards Australia

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Adopts IEC60601-1-6 to specify a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical equipment (ME).

This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.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.If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).

Committee	HE-003
DocumentType	Standard
ISBN	978 1 76035 806 8
Pages	20
PublisherName	Standards Australia
Status	Current
Supersedes	DR AS IEC 60601.1.6:2017 CP

Standards	Relationship
IEC 60601-1-6:2010+AMD1:2013 CSV	Identical

First published as AS IEC 60601.1.6:2017.

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AS IEC 60601.1.6:2017

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

History

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Subcategory

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