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