Standards and Directives

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: 2006+A2: 2009 for Large Steam Sterilizers
  • DIN 58951-2:2003 Steam Sterilizers for Laboratory

Directives & Guidelines

  • 97 /23 /EC - Pressure Equipment Directive
  • 2002 /95 / EC - RoHS Directives – 2002/96
  • 2004 /108 /EC - Electromagnetic compatibility
  • 2006 /95/ EC - Electrical equipment
  • 2006 /42 /EC - Machinery Directive

Safety and EMC Standards

  • EN 61010-1: 2001, EN 61010-2-040: 2005, EN 61326-1: 2006
  • EMC Directive 89/336
  • EN 61326

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 Systems for Medical Devices)
  • 21 CFR 820

 

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