IEC 60601-1-6 Revised
IEC 60601-1-6:2006
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use.
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.
The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.
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A more recent version of this publication exists:
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV
Technical committee
TC 62/SC 62A Common aspects of medical equipment, software, and systemsCategory
Safety| Publication type | International Standard |
| Publication date | 2006-12-08 |
| Edition | 2.0 |
| ICS | 11.040.01 |
| Withdrawal date | 2010-01-27 |
| ISBN number | 2831889332 |
| Pages | 73 |
| File size | 802.85 KB |