Our high quality laboratory autoclaves are designed to comply with the strictest international standards and directives.
Directives
- PED 97/23/EC
- 2006/42/EC Machinery
- 6002/59/EC Electrical equipment
- 2004/108/EC Electromagnetic compatibility
Technical Standards
- EN285: 2006+A2:2009
- DIN 58951-2:2003
- ANSI/AAMI - ST 8: 2008
- EN 61326-1: 2006
- EN 17665-1: 2006
Quality Management System Standards
- ISO 9001:2008 and ISO 13485:2003
- Compliance with FDA QSR 21 CFR part 820 & part 11
- Canadian MDR (CMDR) SOR/98-282 (2006) consolidated