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AAMI ST24 1999 RA 2018

$122.42

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

Published By Publication Date Number of Pages
AAMI 1999 32
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This standard covers minimum labeling, safety, performance, and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use in health care facilities and that have automatic controls. It also covers labeling, product composition, and container requirements for ethylene oxide sterilant sources, as well as labeling, performance, safety, and installation requirements for ethylene oxide emission control systems.

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PDF Pages PDF Title
1 ANSI/AAMI ST24:1999/(R)2018 [HISTORICAL], Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health c
3 Title page
4 AAMI Standard
Copyright
5 Contents
7 Committee representation
11 1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Normative references
12 3 Definitions, symbols, and abbreviations
13 4 Requirements
4.1 Requirements for EO sterilizers
4.1.1 Labeling
4.1.1.1 Device markings
4.1.1.2 Information manual
14 4.1.1.3 Service manual
4.1.1.4 User training program
4.1.2 Sterilizer construction, components, and accessories
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
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
15 4.1.4 Process monitoring devices
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
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
4.2.1 Registration
16 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
4.3.1 System approvals
4.3.2 Labeling
4.3.2.1 Device markings
4.3.2.2 Information/service manuals
4.3.2.3 User training program
17 4.3.3 Performance requirements
4.3.4 Safety requirements
4.3.5 Installation requirements
5 Tests
5.1 Methods of verifying compliance with the requirements for EO sterilizers
5.1.1 Labeling
5.1.2 Sterilizer construction, components, and accessories
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
5.1.3.1 Prevention of worker exposure to EO
5.1.3.2 Prevention of thermal hazards
18 5.1.3.3 Sterilizer controls for aborting cycles
5.1.4 Process monitoring devices
5.1.5 Physical performance of sterilizers
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
19 5.1.7 Certification and recordkeeping
5.2 Methods of verifying compliance with the requirements for EO sterilant sources
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
5.3.1 System approvals
20 5.3.2 Labeling
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
21 Annex A, Rationale for the development and provisions of this standard
A.1 Introduction
A.1.1 Historical background and scope of the standard
A.1.2 Need for the standard
A.2 Normative references
22 A.3 Definitions, symbols, and abbreviations.
A.4 Rationale for the specific provisions of the standard
A.4.1 Requirements for EO sterilizers
A.4.1.1 Labeling
A.4.1.2 Sterilizer construction, components, and accessories
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
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
23 A.4.1.5 Physical performance of sterilizers
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
24 A.4.2 Requirements for EO sterilant sources
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
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
25 Annex B, Calculating chamber relative humidity
B.1 Calculations
B.2 Graphic representation of relative humidity versus pressure
27 Annex C, Calculating chamber ethylene oxide concentration
C.1 Introduction
C.2 Calculations
28 C.3 Example calculations
C.3.1 Determining EO concentration in pounds per cubic foot (lbs/ft3)
29 C.3.2 Determining EO concentration in milligrams/liter (mg/L)
C.4 Derivation of equation (2)
31 Annex D, Bibliography
AAMI ST24 1999 RA 2018
$122.42