Codes and Standards

Sechrist Industries’ design, manufacturing, services and installation systems are certified
to ISO 13485 Quality Assurance Standard for Medical Devices.

In addition, Sechrist Products are designed, fabricated, assembled, tested, and installed in accordance with the following applicable codes and standards, current editions:

• ASME PVHO-1, Safety Standards for Pressure
  Vessels for Human Occupancy
• ASME Boiler and Pressure Vessel Codes,
  Section VIII, Division I, Pressure Vessels
• NFPA 99 Health Care Facilities
• Registered with the National Board of Boiler
  and Pressure Vessel Inspectors
• U.S. FDA Requirement, 21 Code of Federal
  Regulations, Part 820
• ISO 13485: 2003 Quality Assurance Standard
  for Medical Devices
• CMDCAS – Canadian Medical Conformity
  Assessment System
• Medical Device Directive (MDD) 93/42/EEC
• Pressure Equipment Directive (PED) 97/23/EC