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
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