Norm

NEN-EN-IEC 60601-1-6:2010 en

Medische elektrische toestellen - Deel 1-6: Algemene eisen voor basisveiligheid en essentiƫle prestatie - Secundaire norm - Bruikbaarheid

Volledig inclusief:

153,97

Over deze norm

Status Definitief
Aantal pagina's 26
Commissie Medische elektrische toestellen
Gepubliceerd op 01-05-2010
Taal Engels
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. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).

Details

ICS-code 11.040
Nederlandse titel Medische elektrische toestellen - Deel 1-6: Algemene eisen voor basisveiligheid en essentiƫle prestatie - Secundaire norm - Bruikbaarheid
Engelse titel Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Vervangt
Gewijzigd door
Normatieve verwijzingen
  • 90/385/EEG, Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

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