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I.S. EN 60601-1-6:2010&A1:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Available format(s)

Hardcopy , PDF

Superseded date

08-05-2021

Language(s)

English - French

Published date

06-09-2015

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 * Replacement of requirements given in IEC 62366
Annex A (informative) General guidance and rationale
Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007
Annex C (informative) References to items of USABILITY provided in IEC 62366:2007 and their use in other standards
Bibliography
Index of defined terms used with this collateral standard

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.

Committee
TC 62
DocumentType
Standard
ISBN
978-2-8322-1132-8
Pages
84
ProductNote
THIS STANDARD ALSO REFERS TO CEI 60601-1:2005, CEI 60601-1:2005 Amendement 1:2012, CEI 60601-1-8:2006, CEI 60601-1-8:2006 Amendement 1:2012, CEI 62366:2007, CEI 62366:2007 Amendement 1, ANSI/AAMI HE 74:2001. The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 60601-1-6:2010/AMD1:2013 Identical
EN 60601-1-6:2010/A1:2015 Identical

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