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 58951-2:2003  Steam Sterilizers for Laboratory

Directives & Guidelines

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

Safety and EMC Standards

  • EN 61010-1: 2001, EN 61010-2-040: 2005, EN 61326-1: 2006
  • EMC Directive 89/336
  • EN 60529:1991 - Degrees of Enclosure Protection (IPX4)

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 Management Systems for Medical Devices)
  • 21 CFR part 820