CEI EN 60601-1
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Organization: | CEI |
Publication Date: | 1 September 2014 |
Status: | active |
Page Count: | 280 |
ICS Code (Medical equipment): | 11.040 |
scope:
The IEC 60601 series does not apply to:
in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61];
implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or
medical gas pipeline systems covered by ISO 7396-1 [68].
NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.
(*) N.d.R.: Per l'elenco delle Pubblicazioni si veda l'Allegato ZA.