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ANSI/AAMI ST24:1999/(R)2018 - Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities - HISTORICAL, 1999
- ANSI/AAMI ST24:1999/(R)2018 [HISTORICAL], Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health c
- Title page
- AAMI Standard
- Copyright
- Contents
- Committee representation
- 1 Scope [Go to Page]
- 1.1 General
- 1.2 Inclusions
- 1.3 Exclusions
- 2 Normative references
- 3 Definitions, symbols, and abbreviations
- 4 Requirements [Go to Page]
- 4.1 Requirements for EO sterilizers [Go to Page]
- 4.1.1 Labeling [Go to Page]
- 4.1.1.1 Device markings
- 4.1.1.2 Information manual
- 4.1.1.3 Service manual
- 4.1.1.4 User training program
- 4.1.2 Sterilizer construction, components, and accessories [Go to Page]
- 4.1.2.1 Pressure requirements
- 4.1.2.2 Electrical components
- 4.1.2.3 Corrosion resistance
- 4.1.2.4 Air filters
- 4.1.3 Sterilizer safety [Go to Page]
- 4.1.3.1 Prevention of worker exposure to EO
- 4.1.3.2 Prevention of thermal hazards
- 4.1.3.3 Sterilizer controls for aborting cycles
- 4.1.4 Process monitoring devices [Go to Page]
- 4.1.4.1 Temperature measurement
- 4.1.4.2 Pressure measurement
- 4.1.4.3 Exposure time
- 4.1.5 Physical performance of sterilizers [Go to Page]
- 4.1.5.1 Temperature sensors
- 4.1.5.2 Control of exposure time
- 4.1.5.3 Control of relative humidity
- 4.1.5.4 Control of EO delivery
- 4.1.6 Biological performance of sterilizers
- 4.1.7 Certification and recordkeeping
- 4.2 Requirements for EO sterilant sources [Go to Page]
- 4.2.1 Registration
- 4.2.2 Labeling
- 4.2.3 Container safety
- 4.2.4 Product composition
- 4.2.5 Shipping
- 4.3 Requirements for EO emission control systems [Go to Page]
- 4.3.1 System approvals
- 4.3.2 Labeling [Go to Page]
- 4.3.2.1 Device markings
- 4.3.2.2 Information/service manuals
- 4.3.2.3 User training program
- 4.3.3 Performance requirements
- 4.3.4 Safety requirements
- 4.3.5 Installation requirements
- 5 Tests [Go to Page]
- 5.1 Methods of verifying compliance with the requirements for EO sterilizers [Go to Page]
- 5.1.1 Labeling
- 5.1.2 Sterilizer construction, components, and accessories [Go to Page]
- 5.1.2.1 Pressure requirements
- 5.1.2.2 Electrical components
- 5.1.2.3 Corrosion resistance
- 5.1.2.4 Air filters
- 5.1.3 Sterilizer safety [Go to Page]
- 5.1.3.1 Prevention of worker exposure to EO
- 5.1.3.2 Prevention of thermal hazards
- 5.1.3.3 Sterilizer controls for aborting cycles
- 5.1.4 Process monitoring devices
- 5.1.5 Physical performance of sterilizers [Go to Page]
- 5.1.5.1 Temperature control
- 5.1.5.2 Control of exposure time
- 5.1.5.3 Control of relative humidity
- 5.1.5.4 Control of EO delivery
- 5.1.6 Biological performance of sterilizers
- 5.1.7 Certification and recordkeeping
- 5.2 Methods of verifying compliance with the requirements for EO sterilant sources [Go to Page]
- 5.2.1 Registration
- 5.2.2 Labeling
- 5.2.3 Container safety
- 5.2.4 Product composition
- 5.2.5 Shipping
- 5.3 Methods of verifying compliance with the requirements for EO emission control systems [Go to Page]
- 5.3.1 System approvals
- 5.3.2 Labeling [Go to Page]
- 5.3.2.1 Device markings
- 5.3.2.2 Information/service manuals
- 5.3.2.3 User training program
- 5.3.3 Performance requirements
- 5.3.4 Safety requirements
- 5.3.5 Installation requirements
- Annex A, Rationale for the development and provisions of this standard [Go to Page]
- A.1 Introduction [Go to Page]
- A.1.1 Historical background and scope of the standard
- A.1.2 Need for the standard
- A.2 Normative references
- A.3 Definitions, symbols, and abbreviations.
- A.4 Rationale for the specific provisions of the standard [Go to Page]
- A.4.1 Requirements for EO sterilizers [Go to Page]
- A.4.1.1 Labeling
- A.4.1.2 Sterilizer construction, components, and accessories [Go to Page]
- A.4.1.2.1 Pressure requirements
- A.4.1.2.2 Electrical components
- A.4.1.2.3 Corrosion resistance
- A.4.1.2.4 Air filters
- A.4.1.3 Sterilizer safety [Go to Page]
- A.4.1.3.1 Prevention of worker exposure to EO
- A.4.1.3.2 Prevention of thermal hazards
- A.4.1.3.3 Sterilizer controls for aborting cycles
- A.4.1.4 Process monitoring devices
- A.4.1.5 Physical performance of sterilizers [Go to Page]
- A.4.1.5.1 Temperature control
- A.4.1.5.2 Control of exposure time
- A.4.1.5.3 Control of relative humidity
- A.4.1.5.4 Control of EO delivery
- A.4.1.6 Biological performance of sterilizers
- A.4.1.7 Certification and recordkeeping
- A.4.2 Requirements for EO sterilant sources [Go to Page]
- A.4.2.1 Registration
- A.4.2.2 Labeling
- A.4.2.3 Container safety
- A.4.2.4 Product composition
- A.4.2.5 Shipping
- A.4.3 Requirements for EO emission control systems [Go to Page]
- A.4.3.1 System approvals
- A.4.3.2 Labeling
- A.4.3.3 Performance requirements
- A.4.3.4 Safety requirements
- A.4.3.5 Installation requirements
- Annex B, Calculating chamber relative humidity [Go to Page]
- B.1 Calculations
- B.2 Graphic representation of relative humidity versus pressure
- Annex C, Calculating chamber ethylene oxide concentration [Go to Page]
- C.1 Introduction
- C.2 Calculations
- C.3 Example calculations [Go to Page]
- C.3.1 Determining EO concentration in pounds per cubic foot (lbs/ft3)
- C.3.2 Determining EO concentration in milligrams/liter (mg/L)
- C.4 Derivation of equation (2)
- Annex D, Bibliography [Go to Page]