ASME Code Section I and Section VIII. Div. I
PED 2014/68/EU
Chinese Regulations Special Equipment Licensing Office
EN 13060: Small Steam Sterilizer
ANSI/AAMI/ST55: Tabletop Steam Sterilizer
ISO 17665:
Sterilization of health care products –
Moist heat
ANSI/AAMI/ST79:
Comprehensive guide to steam
sterilization and sterility assurance in
health care facilities
IEC 61010-1 / UL 61010-1:
Safety requirements for electrical
equipment for measurement, control, and
laboratory use – Part 1: General
requirements
IEC 61010-2-040:
Safety requirements for electrical
equipment for measurement, control, and
laboratory use – Part 2-040: Requirements
for sterilizers and washer-disinfectors
used to treat medical materials
EN 613261-1:
EMC Requirements for Electrical
Equipment
IEC 62304:
Medical Device Software – Software life
cycle processes
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