Our high quality laboratory autoclaves are designed to comply with the strictest international standards and directives.
Directives
- PED 97/23/EC
Technical Standards
- EN 285 for Large Autoclaves
- ST 8 for Hospital Sterilizers
- EN 61326-1
- EN 17665-1 Sterilization of Health Care Products - Moist Heat
Quality Management System Standards
- ISO 900 - Quality Management System
- ISO 13485 - Quality Management System – Medical devices
- Compliance with FDA QSR 21 CFR part 820 & part 11
- Canadian MDR (CMDR) SOR/98-282 (2018) consolidated