NEN-EN-IEC 60601-1-6/A2
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 July 2021 |
| Status: | active |
| Page Count: | 30 |
| ICS Code (Medical equipment): | 11.040 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.
NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.
Document History
NEN-EN-IEC 60601-1-6/A2
July 1, 2021
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE is...
June 1, 2015
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
A description is not available for this item.
May 1, 2010
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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...
March 1, 2010
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
A description is not available for this item.
September 1, 2007
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
This International Standard 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...
November 1, 2004
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard - Usability
Medical practice is increasingly using medical electrical equipment for observation and treatment of patients. use errors caused by inadequate medical electrical equipment usability have become an...