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2.13 Directives and Standards
Every autoclave meets the provisions of the following Directives and is
designed, manufactured and tested in compliance with the following
Standards:
2.13.1 Technical Directives
1. Medical device directive MDD/93/42/EEC.
2.13.2 Technical Standards
1. A.S.M.E. Code section VIII division 1 for pressure
vessels.
2. UL3101-1 for Laboratory use Electrical Equipment.
3. UL/IEL/EN 61010-1 – Safety of electrical equipment
…General requirement.
4. UL/IEL/EN 61010-2-041 – Particular requirement for steam
autoclaves.
5. UL listed E206879
6. ANSI/AAMI ST-55 Table-Top Steam Sterilizer
2.13.3 Quality standards
The manufacturing 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.
3. 21CFR820 GMP for Medical Devices
The manufacturer retains all supporting documentation.
Both models were tested in accordance with ANSI/AAMI ST-55.
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