Our high quality research laboratory autoclaves are designed to comply with the strictest international directives and standards in all aspects of the animal care market.
Technical Standards and Directives
- 97/23/EC - Pressure Equipment Directive
- EN 285:2006+A2: 2009 - Large Steam Sterilizers
- DIN 58951-2:2003 - Steam Sterilizers for Laboratory
- EN 61010-1: 2001, EN 61010-2-040: 2005, EN 61326-1: 2006
- ASME Sec. VIII Div.1 and Sec. I, ASME BPE
- ISO 17665-1: 2006
- 89/336 - EMC Directive
- EN 60529:1991 - Degrees of Enclosure Protection (IPX4)
- ANSI/AAMI ST-8: 2008
- 2002/95/EC - RoHS Directives
- 2004/108/EC - Electromagnetic Compatibility
- 2006/95/EC - Electrical Equipment
- 2006/42/EC - Machinery Directive
Tuttnauer manufacturing plant meets the following quality standards
- ISO 9001: 2008 - Quality Management Systems
- ISO 13485: 2003 - Quality Management Systems for Medical Devices
- Compliance with FDA QSR 21 CFR part 820 & part 11
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