AAMI ST24 1999 RA 2018
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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
| Published By | Publication Date | Number of Pages |
| AAMI | 1999 | 32 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST24:1999/(R)2018, Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health c |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 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 |
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AAMI ST24 1999 RA 2018
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