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eLibrary > ANSI/AAMI ST24:2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities >

ANSI/AAMI ST24:2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities, 2024

ANSI/AAMI ST24:2024; General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
Title page
AAMI Standard
Copyright information
Contents
Committee representation
Foreword
Introduction
1 Scope [Go to Page]
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Normative references
3 Terms and definitions
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 Control of temperature
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 Labeling [Go to Page]
4.3.1.1 Device markings
4.3.1.2 Information/service manuals
4.3.1.3 User training program
4.3.2 Performance requirements
4.3.3 Safety requirements
4.3.4 Installation requirements
5 Tests [Go to Page]
5.1 Methods of verifying conformance 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 [Go to Page]
Figure 1—Preparation of the PCD (routine BI test pack) (drawing not to scale)
Figure 2—Placement of BI in syringe
Figure 3—Some components of the PCD (challenge BI test pack)
Figure 4—Placement of components in PCD (challenge BI test pack)
Table 1—Test pack number and location for empty-chamber testing
Table 2—Number of test packs for simulated-load testing
5.1.7 Certification and recordkeeping
5.2 Methods of verifying conformance 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 (informative) 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 Terms and definitions
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.4.1.3 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
Annex B (informative) Calculating chamber relative humidity [Go to Page]
B.1 Calculations [Go to Page]
Table B.1—Temperature versus saturation pressure of water vapor
B.2 Graphic representation of relative humidity versus pressure [Go to Page]
Figure B.1—Relative humidity versus partial pressure for two common sterilization temperatures
Annex C (informative) Calculating chamber ethylene oxide concentration [Go to Page]
C.1 Introduction
C.2 Calculations [Go to Page]
Table C.1—EO constant and molecular weight
Table C.2—Gas constants (R =PV/nt)*
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)
Bibliography [Go to Page]

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