BS ISO 11197:2016 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, NT, hereafter also referred to as ME EQUIPME.

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+A1:2012 (see 201.1.4).

NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.


Cross References:
IEC 60601-1:2005+A1:2012
IEC 60364-5-54:2011
IEC 60364-7-710:2002
IEC 60529:1989+AMD1:1999
IEC 60598-1:2014
IEC 60601-1:2005+A1:2012
IEC 60601-1-2:2014
IEC 60601-1-3:2008
IEC 60601-1-6:2010
IEC 60601-1-8:2006+A1:2012
IEC 60601-1-9:2007
IEC 60601-1-10:2007
IEC 61386-1:2008
IEC 61950:2007
ISO 3744:2010
ISO 5359:2014
ISO 7396-1:2007
ISO 7396-2:2007
ISO 9170-1:2008
ISO 9170-2:2008
ISO 14971:2007
ISO 16571:2014
EN 50174-1:2009+A2:2014
EN 50174-2:2009+A2:2014
EN 60446
EN 13348
EN 61140


All current amendments available at time of purchase are included with the purchase of this document.