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:
- EN 285 for Large Autoclaves
- ST8 – Hospital Sterilizers
Directives & Guidelines:
- Medical Device Directive 93/42/EEC as amended by 2007/47/EC
- Pressure Equipment Directives – PED 97/23 EEC6
- 2012/19/EU WEEE and EU 2017/2102 Restriction of the use of certain hazardous substances (RoHS Directive)
Safety and EMC Standards:
- UL/EN 61010-1
- UL/EN 61010-2-040
- EN 61326-1
- 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 Sterilization of Health Care Products - Moist Heat
Quality System Standards:
- ISO 9001 (Quality Systems)
- ISO 13485 (Quality Systems for Medical Devices)
- FDA QSR 21 CFR part 820 & part 11
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