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.
Standards and Codes
Tuttnauer products meet the following provisions and standards:
Europe:
- EN 285 for Large Autoclaves
- DIN 58951 Steam Sterilizers for Laboratory Use
USA:
- ST8 – Hospital Sterilizers
Directives & Guidelines:
- Medical Device Directive – MDD 93/42 EEC (will be replaced by MDD 2007/47)
- Pressure Equipment Directives – PED 97/23 EEC
- Low Voltage Directive – 73/23 EEC
- EMC Directive 89/336
- WEE & RoHS Directives – 2002/95, 96
Safety and EMC Standards:
- IEC/UL/EN 61010-1
- IEC/EN 61010-2-040
- EN 61326
- International Protection Level IPx4
Pressure Vessel and Steam Generator Construction Standards:
- ASME Code, Section VIII, Division 1, unfired pressure vessels
- ASME Code, Section I, for boilers
- ISO 17665-1 (replacing ISO 13683 and ISO 11134)
- ST79 (replacing ST46 and ST42)
Quality System Standards:
- ISO 9001:2008 (Quality Systems)
- ISO 13485:2003 (Quality Systems for Medical Devices)
- 21 CFR 820