BS EN 60601-1-6 : 2010
Current
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
Hardcopy , PDF
English
01-01-2010
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
Annex ZA (normative) - Normative references to international
publications with their European publications
Annex ZZ (informative) - Coverage of Essential Requirements of
EU Directives
Describes 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 |
CH/62/1
|
| DevelopmentNote |
Supersedes 03/304741 DC. (12/2004) 2010 Edition remains active & will be withdrawn on 31/12/2018. 2010 Edition Re-Issued in July 2015 & incorporates AMD 1 2015. Supersedes 12/30258857 DC. (07/2015)
|
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN 60601-1-6 : 2016 | Identical |
| NF EN 60601-1-6 : 2010 AMD 1 2015 | Identical |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Identical |
| I.S. EN 60601-1-6:2010 | Identical |
| EN 60601-1-6:2010 | Equivalent |
| UNE-EN 60601-1-6:2010 | Identical |
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