SNV - SN EN ISO 11197
Medical supply units
Organization: | SNV |
Publication Date: | 1 June 2020 |
Status: | active |
Page Count: | 48 |
ICS Code (Anaesthetic, respiratory and reanimation equipment): | 11.040.10 |
scope:
IEC 60601-1:2005+A1:2012
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit. Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012
NOTE 2 Refer to IEC 60601-1:2005+A1:2012