CEN - EN ISO 11197
Medical supply units
|Publication Date:||1 March 2016|
|ICS Code (Anaesthetic, respiratory and reanimation equipment):||11.040.10|
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT.
This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site, including cabinetry and other ENCLOSURES, which incorporate PATIENT care services.
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 International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005 (see 201.1.4).
NOTE 2 See also IEC 60601-1:2005+A1:2012