Page 20
1.23.
Directives and Standards
Every autoclave meets the provisions of the following Directives and is in
compliance with the following Standards:
Medical Device Directive 93/42/EEC as amended by 2007/47/EC
Medical Device Single Audit Program
– (MDSAP)
ISO 9001:
Quality Management System
EN ISO 13485:
Quality Management System
– Medical Devices
ISO 14001:
Environmental management system
ISO 17025:
General requirements for the competence of testing
and calibration laboratories
EN ISO 14971:
Medical devices
– Application of risk management for
medical devices
ASME Code
Section I and Section VIII. Div. I
PED
2014/68/EU
Chinese Regulations
Special Equipment Licensing Office
EN 13060:
Small Steam Sterilizers
ANSI/AAMI/ST55
:
Table Top 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
