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4.11.
Directives and Standards
Every autoclave meets the provisions of the following Directives and is
in compliance with the following Standards:
4.11.1.
Technical Standards
1.
ANSI/AAMI ST55 – Small Steam Sterilizers.
2.
ASME Code, section VIII division 1 for pressure
vessels.
3.
UL 61010-1 electrical equipment for laboratory use;
general requirements
4.
IEC 61010-2-040 particular requirements for sterilizers
and washer disinfectors used to treat medical materials.
The following standards were taken in consideration:
5.
ANSI/AAMI ST79, Comprehensive guide to steam
sterilization and sterility assurance in health care
facilities
6.
ISO 17665-1:2006 specifies requirements for the
development, validation and routine control of a moist
heat sterilization process for medical devices.
4.11.2.
Quality standards
The manufacturing plant meets the following quality
standards:
1.
EN ISO 9001:2008– Quality System
2.
ISO
13485:2003
– Quality systems – Medical devices.
3.
21 CFR 820 – Quality System
