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PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities >
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PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities, 2021
- undefined
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General
- 4.1 Product definition
- 4.2 Equipment development
- 4.3 Calibration
- 5 Equipment design and construction
- 5.1 Safety and security
- 5.2 Chamber
- 5.2.1 Dimensions
- 5.2.2 Doors
- 5.2.3 Chamber integrity
- 5.2.4 Pressure vessels
- 5.2.5 Uniformity of conditions
- 5.2.6 Ancillary equipment and components
- 5.3 Materials
- 5.4 Interlocks
- 5.5 Test connections
- 5.6 Vibration
- 5.7 User interfaces
- 6 Indicating, monitoring, controlling and recording
- 6.1 General
- 6.2 Automatic control
- 6.3 Control and monitoring system
- 6.4 Failure
- 6.4.1 General
- 6.4.2 Fault
- 6.4.3 Power failure
- 6.4.4 Other failures
- 6.5 Instrumentation
- 6.6 Indicating devices
- 6.7 Recorders
- 7 Services and local environment
- 7.1 General
- 7.2 Sterilizing agent and sterilant
- 7.3 Electrical supply
- 7.4 Water
- 7.5 Steam
- 7.6 Vacuum
- 7.7 Drains
- 7.8 Lighting
- 7.9 Compressed air
- 7.10 Air and inert gases
- 7.11 Ventilation
- 8 Emissions
- 8.1 Electromagnetic emissions
- 8.2 Noise
- 8.3 Exhaust emissions
- 8.4 Heat emission
- 9 Test instrumentation
- 10 Performance and assessment
- 10.1 General
- 10.2 Chamber integrity
- 10.3 Attainment of conditions
- 10.4 Microbiological performance
- 10.5 Pressure change
- 11 Information supplied by the manufacturer
- 11.1 General
- 11.2 Information to be made available prior to purchase
- 11.3 Marking
- 11.4 Label
- 11.5 Instructions for use
- 11.6 Technical description
- Annex A (informative) Rationale for requirements
- Annex B (informative) Illustrations of the interrelationship between control and recording
- Bibliography [Go to Page]
