Esileht»E-pood»EVS-EN 60601-1-6:2010

EVS-EN 60601-1-6:2010

Alusta uut otsingut

Osta standard

Staatus: Kehtiv

Hind: 12,51 EUR

Sirvi standardit

Tervikteksti sirvimine

Hind: 2,00 EUR

Lisa monitooringusse

Elektrilised meditsiiniseadmed. Osa 1-6: Üldnõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Kasutussobivus

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.

See standard on harmoneeritud standard Direktiivi 93/42/EÜ (meditsiiniseadmed) mõistes, arvestades järgmist märkust:
(*): Selles  Euroopa standardis ei tarvitse sisalduda direktiivi 2007/47/EÜ nõuded.

Anna tagasisidet selle standardi sisu kohta