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.<\/p>\n
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| 1<\/td>\n | ANSI\/AAMI ST24:2024; \nGeneral-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 3 Terms and definitions 4 Requirements 4.1 Requirements for EO sterilizers 4.1.1 Labeling <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4.1.1.1 Device markings 4.1.1.2 Information manual 4.1.1.3 Service manual <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.1.3.2 Prevention of thermal hazards 4.1.3.3 Sterilizer controls for aborting cycles 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 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 <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4.1.7 Certification and recordkeeping 4.2 Requirements for EO sterilant sources 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 4.3.1 Labeling 4.3.1.1 Device markings 4.3.1.2 Information\/service manuals <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.3.1.3 User training program 4.3.2 Performance requirements 4.3.3 Safety requirements 4.3.4 Installation requirements 5 Tests 5.1 Methods of verifying conformance 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 <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.1.3 Sterilizer safety 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 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 <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Figure 1\u2014Preparation of the PCD (routine BI test pack) (drawing not to scale) Figure 2\u2014Placement of BI in syringe <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | Figure 3\u2014Some components of the PCD (challenge BI test pack) Figure 4\u2014Placement of components in PCD (challenge BI test pack) <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Table 1\u2014Test pack number and location for empty-chamber testing Table 2\u2014Number 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 5.2.1 Registration 5.2.2 Labeling 5.2.3 Container safety 5.2.4 Product composition 5.2.5 Shipping <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.3 Methods of verifying compliance with the requirements for EO emission control systems 5.3.1 System approvals 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 <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | Annex A (informative) 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 <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | A.3 Terms and definitions 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.4.1.3 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 <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Annex B (informative) Calculating chamber relative humidity B.1 Calculations Table B.1\u2014Temperature versus saturation pressure of water vapor B.2 Graphic representation of relative humidity versus pressure <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Figure B.1\u2014Relative humidity versus partial pressure for two common sterilization temperatures <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Annex C (informative) Calculating chamber ethylene oxide concentration C.1 Introduction C.2 Calculations <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Table C.1\u2014EO constant and molecular weight Table C.2\u2014Gas constants (R =PV\/nt)* C.3 Example calculations C.3.1 Determining EO concentration in pounds per cubic foot (lbs\/ft3) C.3.2 Determining EO concentration in milligrams\/liter (mg\/L) <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" 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<\/b><\/p>\n |