Standards
Our high quality medical waste autoclaves are designed to comply with the strictest international directives and standards in all aspects of waste treatment and waste disposal.
- EN 285 for Large Autoclaves
- DIN 58951-2:2003 Steam Sterilizers for Laboratory
Directives & Guidelines
- PED 97/23 EC - Pressure Equipment Directive
- 2002/95/EC - RoHS Directives
- 2004/108/EC - Electromagnetic compatibility
- 2006/95/EC - Electrical equipment
- 2006/42 - Machinery Directive
Safety and EMC Standards
- EN 61010-1: 2001, EN 61010-2-040: 2005, EN 61326-1: 2006
- EMC Directive 89/336
- EN 60529:1991 - Degrees of Enclosure Protection (IPX4)
Pressure Vessel and Steam Generator Construction Standards
- ASME Code, Section VIII, Division 1, unfired pressure vessels
- ASME Code, Section I, for boilers
Good Practice Standards
- ISO 17665-1: 2006
- ANSI/AAMI – ST 8: 2008
Quality System Compliance
- ISO 9001:2008 (Quality Systems)
- ISO 13485:2003 (Quality Management Systems for Medical Devices)
- 21 CFR part 820