Expertise Steam Sterilization | SHP Steriltechnik AG

Large steam sterilizers

Large steam sterilizers

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The draft E DIN EN 285:2002-12 describes requirements for large steam sterilizers for use in healthcare and in the manufacture of medical products.

 

Scope of application

  • Large steam sterilizers with a chamber size ≥ 1 SEU (sterilization unit)
  • Use in healthcare and in the commercial manufacture of medical products
  • Suitable for: packaged metal goods, rubber hoses, porous materials, textiles, long hollow bodies
  • Definition of representative test loads for validation

 

Not applicable for:

Steam sterilizers with a usable space of less than 1 SE or less than 60 liters

  • Sterilization of liquids
  • Sterilization of pharmaceutical products or devices

 

Terms & components

Mechanical components

  • Dimensions, materials, pressure equipment
  • Frame and cladding

Process engineering components

  • Pipes, fittings, steam generators
  • Air filters, vacuum system

Instrumentation

  • Sensors, display and recording devices
  • Timers, recording devices

 

Control systems

  • Automatic control with preset sterilization cycles
  • Fault display system for safety and process monitoring

 

Performance requirements

  • Steam penetration: Uniform temperature distribution even in textiles or long hollow bodies
  • Germ elimination: Validation using biological indicators
  • Physical tests: Temperature profiles, Bowie-Dick test, air leakage test
  • Drying: Ensuring dry loads for sterile storage
  • Additional requirements: Sound performance, pressure change rates

 

Safety requirements & operation

  • Protective mechanisms & equipment safety
  • Labeling requirements

 

Operating materials & installation site

  • Electrical supply
  • Steam and water connections
  • Compressed air supply
  • Electromagnetic compatibility
  • Installation areas, ambient conditions, technical connections

 

Tests & reference standard

The standard DIN 58946-6:2002-04 is recommended for the operation and testing of large sterilizers:

  • Title: Steam sterilizers – Part 6: Operation of large sterilizers in healthcare facilities
  • Contains information on the implementation of test programs and validation of device performance
  EN