I.S. EN 60601-1-6:2010/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
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.
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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
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 |
978-2-8322-8628-9
|
| Pages |
112
|
| ProductNote |
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 |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-6:2010/AMD2:2020 | Identical |
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