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3.11. Directives and Standards
Every autoclave meets the provisions of the following Directives and is
in compliance with the following Standards:
3.11.1. Technical Standards
1. EN 13060:2004 – Small Steam Sterilizers.
2. ASME Code, section VIII division 1 for pressure
vessels.
3. EN 61326, Electrical equipment for measurement,
control and laboratory use-EMC requirements
4. UL/IEL/EN 61010-1 electrical equipment for
laboratory use; general requirements
5. UL/IEL/EN 61010-2-041 particular requirements for
autoclaves using steam for the treatment of medical
materials and for laboratory processes
6. UL/IEL/EN 61010-2-040 particular requirements for
sterilizers and washer disinfectors used to treat medical
materials.
The following standards were taken in consideration:
7. EN 554 Sterilization of Medical Devices - Validation
and Routine Control of Sterilization by Moist Heat
8. ISO 13683 Sterilization of Health Care Products -
Requirements for Validation and Routine Control of
Moist Heat Sterilization in Health Care Facilities
3.11.2. Quality standards
The manufacturing plant meets the following quality
standards:
1. EN ISO 9001:2000– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices –
Particular requirements for the application of ISO 9001.
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