Tuttnauer autoclaves are FDA cleared and comply with the following 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.
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