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2.11 Directives and Standards
The autoclaves are FDA cleared and comply with the following
Standards:
2.11.1 Technical Standards
1. A.S.M.E. Code, Section VIII div.1 for unfired pressure vessels.
2. AAMI/ANSI ST-55:2001 Tabletop steam sterilizers.
3. UL61010-1 Safety for Electrical Equipment for Measurement,
Control, and Laboratory Use, General Requirements.
4. UL61010-2-041 Particular Safety for Autoclaves.
2.11.2 Quality Standards
The manufacturing plant meets the following quality standards:
1. EN ISO 9001:2000:2008– Quality System.
2. ISO 13485:2003 – Quality systems – Medical devices –
Particular requirements for the application of ISO 9001.
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