CEI EN 60601-1-6
Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral standard: Usability
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| Organization: | CEI |
| Publication Date: | 1 January 2016 |
| Status: | active |
| Page Count: | 14 |
| ICS Code (Medical equipment): | 11.040 |
scope:
INTRODUCTION TO THE AMENDMENT
The third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle process elements that are inconsistent with a TYPE TEST. This amendment is intended to clarify the elements of the USABILITY ENGINEERING PROCESS that are required for compliance with the IEC 60601 series.
Document History
April 1, 2022
Medical electrical equipment Part 1: 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...
CEI EN 60601-1-6
January 1, 2016
Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral standard: Usability
INTRODUCTION TO THE AMENDMENT
The third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge that enables a MANUFACTURER to conform to the requirements in IEC 60601-1...
May 1, 2011
Medical electrical equipment Part 1: General requirements for basic safety and essential performance Collateral standard: Usability
La presente Norma specifica un processo destinato a un costruttore per analizzare, specificare, progettare, verificare e validare l'usabilità, quando ci si riferisce alla sicurezza fondamentale e...
May 1, 2010
Apparecchi elettromedicali - Parte 1: Prescrizioni generali relative alla sicurezza fondamentale e alle prestazioni essenziali - Norma collaterale: Usabilità
La presente Variante recepisce il corrigendum EN 60601-1-6/EC:2010-03 che introduce una DOW al 2012-06-01 e cancella le frasi che non sono più valide.
February 1, 2008
Apparecchi elettromedicali - Parte 1: Prescrizioni generali relative alla sicurezza fondamentale e alle prestazioni essenziali - Norma collaterale: Usabilità
La presente Norma collaterale specifica le prescrizioni relative a un processo per analizzare, progettare, verificare e validare la caratteristica dell'usabilità delle apparecchiature elettromedicali...
October 1, 2005
Apparecchi elettromedicali - Parte 1: Norme generali per la sicurezza - Norma collaterale: Usabilità
La presente Norma collaterale specifica le prescrizioni relative a un processo per analizzare, progettare, verificare e validare la caratteristica dell'"usabilità" delle apparecchiature...