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Large Waste AutoclaveStandards and Directives

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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 Steam Sterilizers for Laboratory Use

Directives & Guidelines

  • Pressure Equipment Directive – PED 97/23 EEC
  • EMC Directive 89/336
  • RoHS Directives – 2002/96
  • Low Voltage Directive 73/27
  • Machinery Directive – 2006/42

Safety and EMC Standards

  • IEC/UL/EN 61010-1
  • IEC/EN 61010-2-040
  • EN 61326

Pressure Vessel and Steam Generator Construction Standards

  • ASME Code, Section VIII, Division 1, unfired pressure vessels
  • ASME Code, Section I, for boilers
  • EN 13445 for Pressure vessels
  • EN 14222 and EN 12953 for steam boilers

Good Practice Standards

  • ISO 17665-1
  • ST79

Quality System Compliance

  • ISO 9001:2008 (Quality Systems)
  • ISO 13485:2003 (Quality Systems for Medical Devices)
  • 21 CFR 820