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ANSI/AAMI/ST8:2013/(R)2018 - Hospital steam sterilizers, 2013
- ANSI/AAMI ST8:2013/(R)2018, Hospital steam sterilizers
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Foreword
- 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 Labeling [Go to Page]
- 4.1.1 Device markings [Go to Page]
- 4.1.1.1 Identification
- 4.1.1.2 Safety
- 4.1.2 Information manual
- 4.1.3 Service manual
- 4.2 Sterilizer design, construction, components, and accessories [Go to Page]
- 4.2.1 Pressure requirements
- 4.2.2 Pressure vessel certification
- 4.2.3 Electrical components
- 4.2.4 Corrosion resistance [Go to Page]
- 4.2.4.1 Sterilizer surfaces
- 4.2.4.2 Loading accessories
- 4.2.5 Air filters
- 4.3 Sterilizer safety
- 4.3.1 Interlock [Go to Page]
- 4.3.2 Prevention of thermal hazards
- 4.3.3 Sterilizer controls for aborting cycles
- 4.4 Process monitoring and control devices [Go to Page]
- 4.4.1 General
- 4.4.2 Chamber temperature [Go to Page]
- 4.4.2.1 Temperature monitoring and recording
- 4.4.2.2 Positioning of temperature sensors
- 4.4.2.3 Accuracy of temperature measurement
- 4.4.2.4 Resolution of temperature measurement
- 4.4.2.5 Sterilizer temperature control
- 4.4.2.6 Exposure temperature
- 4.4.3 Thermometric test connection
- 4.4.4 Sterilizer exposure timer
- 4.4.5 Pressure measurement [Go to Page]
- 4.4.5.1 Chamber pressure indicator
- 4.4.5.2 Jacket pressure indicator
- 4.4.6 Cycle documentation
- 4.5 Biological performance of sterilizers
- 4.6 Mechanical air removal [Go to Page]
- 4.6.1 Air removal (dynamic-air-removal sterilizers)
- 4.6.2 Air leaks (prevacuum sterilizers)
- 4.7 Moisture retention
- 4.8 Sterilizer performance certification and record-keeping
- 5 Tests [Go to Page]
- 5.1 Labeling
- 5.2 Sterilizer design, construction, components, and accessories [Go to Page]
- 5.2.1 Pressure requirements
- 5.2.2 Pressure vessel certification
- 5.2.3 Electrical components
- 5.2.4 Corrosion resistance [Go to Page]
- 5.2.4.1 Sterilizer surfaces
- 5.2.4.2 Loading accessories
- 5.2.5 Air filters
- 5.3 Sterilizer safety [Go to Page]
- 5.3.1 Interlock
- 5.3.2 Prevention of thermal hazards
- 5.3.3 Sterilizer controls for aborting cycles
- 5.4 Process monitoring and control devices [Go to Page]
- 5.4.1 General
- 5.4.2 Chamber temperature [Go to Page]
- 5.4.2.1 Temperature monitoring and recording
- 5.4.2.2 Positioning of temperature sensors
- 5.4.2.3 Accuracy of temperature measurement
- 5.4.2.4 Resolution of temperature measurement
- 5.4.2.5 Sterilizer temperature control
- 5.4.3 Thermometric test connection
- 5.4.4 Sterilizer exposure timer
- 5.4.5 Pressure indicators [Go to Page]
- 5.4.5.1 Chamber pressure indicator
- 5.4.5.2 Jacket pressure indicator
- 5.4.6 Cycle documentation
- 5.5 Biological performance of sterilizers [Go to Page]
- 5.5.1 General testing requirements
- 5.5.2 Biological performance with a fabric PCD [Go to Page]
- 5.5.2.1 Construction of the fabric PCD
- 5.5.2.2 Placement of the fabric PCD
- 5.5.2.3 Cycle operation
- 5.5.2.4 Incubation of BIs
- 5.5.2.5 Acceptance criteria
- 5.5.3 Biological performance with liquid loads (if applicable) [Go to Page]
- 5.5.3.1 Test flasks
- 5.5.3.2 Placement of test flasks
- 5.5.3.3 Cycle operation
- 5.5.3.4 Incubation of BIs
- 5.5.3.5 Acceptance criteria
- 5.5.4 Biological performance with wrapped instrument PCD [Go to Page]
- 5.5.4.1 Construction of the wrapped instrument PCD
- 5.5.4.2 Placement of the wrapped instrument PCD
- 5.5.4.3 Cycle operation
- 5.5.4.4 Incubation of BIs
- 5.5.4.5 Acceptance criteria
- 5.5.5 Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items [Go to Page]
- 5.5.5.1 Gravity-displacement cycles for unwrapped nonporous items [Go to Page]
- 5.5.5.1.1 General
- 5.5.5.1.2 Construction of the PCD
- 5.5.5.1.3 Placement of the PCD
- 5.5.5.1.4 Cycle operation
- 5.5.5.1.5 Acceptance criteria
- 5.5.5.2 Dynamic-air-removal cycles for single-wrapped or unwrapped nonporous items [Go to Page]
- 5.5.5.2.1 General
- 5.5.5.2.2 Construction of the PCD
- 5.5.5.2.3 Placement of the PCD
- 5.5.5.2.4 Cycle operation
- 5.5.5.2.5 Acceptance criteria
- 5.6 Mechanical air removal tests [Go to Page]
- 5.6.1 Air removal test (dynamic-air-removal sterilizers) [Go to Page]
- 5.6.1.1 Test pack construction
- 5.6.1.2 Test pack placement
- 5.6.1.3 Cycle operation
- 5.6.1.4 Acceptance criteria
- 5.6.2 Air leak-rate test (prevacuum sterilizers) [Go to Page]
- 5.6.2.1 General
- 5.6.2.2 Test procedure
- 5.6.2.3 Acceptance criteria
- 5.7 Moisture retention tests [Go to Page]
- 5.7.1 Moisture retention with a fabric PCD [Go to Page]
- 5.7.1.1 Construction of the PCD
- 5.7.1.2 Placement of the PCD
- 5.7.1.3 Cycle operation
- 5.7.1.4 Acceptance criteria
- 5.7.2 Moisture retention with a wrapped instrument PCD [Go to Page]
- 5.7.2.1 Construction of the PCD
- 5.7.2.2 Placement of the PCD
- 5.7.2.3 Cycle operation
- 5.7.2.4 Acceptance criteria
- 5.8 Sterilizer performance certification and record-keeping
- 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 Definitions, symbols, and abbreviations
- A.4 Rationale for the specific provisions of the standard [Go to Page]
- A.4.1 Labeling
- A.4.2 Sterilizer design, construction, components, and accessories [Go to Page]
- A.4.2.1 Pressure requirements
- A.4.2.2 Pressure vessel certification
- A.4.2.3 Electrical components
- A.4.2.4 Corrosion resistance
- A.4.2.5 Air filters
- A.4.3 Sterilizer safety
- A.4.3.2 Prevention of thermal hazards
- A.4.3.3 Sterilizer controls for aborting cycles
- A.4.4 Process monitoring and control devices
- A.4.5 Biological performance of sterilizers
- A.4.6 Mechanical air removal [Go to Page]
- A.4.6.1 Air removal (dynamic-air-removal sterilizers)
- A.4.6.2 Air leaks (prevacuum sterilizers)
- A.4.7 Sterilizer performance certification and record-keeping
- Annex B (Informative) Examples of cycle documentation
- Annex C (Informative) Bibliography [Go to Page]