I.S. EN 60601-1-6:2010&A1:2015&A2:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Hardcopy , PDF
English
02-08-2021
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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
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