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ANSI/AAMI ST40:2004/(R)2018 - Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2004
- ANSI/AAMI ST40:2004/(R)2018, Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Recommended Practice
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Foreword
- Introduction: Need for this recommended practice
- 1 Scope [Go to Page]
- 1.1 General
- 1.2 Inclusions
- 1.3 Exclusions
- 2 Definitions, symbols, and abbreviations
- 3 Design considerations [Go to Page]
- 3.1 General rationale
- 3.2 Work area design and functional workflow [Go to Page]
- 3.2.1 Definitions of work areas
- 3.2.2 Design criteria
- 3.2.3 Functional workflow patterns
- 3.2.4 Traffic control
- 3.3 Physical facilities [Go to Page]
- 3.3.1 Space requirements
- 3.3.2 Mechanical and electrical systems
- 3.3.3 General area requirements [Go to Page]
- 3.3.3.1 Ceilings, floors, walls, and work areas
- 3.3.3.2 Ventilation
- 3.3.3.3 Temperature and humidity
- 3.3.3.4 Lighting
- 3.3.3.5 Handwashing facilities
- 3.3.4 Special area considerations [Go to Page]
- 3.3.4.1 Decontamination
- 3.3.4.2 Preparation and assembly
- 3.3.4.3 Sterilization
- 3.3.4.4 Sterile storage
- 3.4 Housekeeping
- 4 Personnel considerations [Go to Page]
- 4.1 General rationale
- 4.2 Qualifications
- 4.3 Training and continuing education
- 4.4 Health and personal hygiene
- 4.5 Attire [Go to Page]
- 4.5.1 General
- 4.5.2 Decontamination area
- 4.6 Standard/transmission-based (enhanced) precautions
- 5 Processing recommendations [Go to Page]
- 5.1 General rationale
- 5.2 Receiving [Go to Page]
- 5.2.1 General considerations
- 5.2.2 Newly purchased reusable items and repaired reusable items
- 5.2.3 Disposable items
- 5.3 Disposition of sterile items (issued but not used)
- 5.4 Handling, collection, and transport of items previously used in patient care
- 5.5 Cleaning and other decontamination processes [Go to Page]
- 5.5.1 General considerations
- 5.5.2 Presoaking
- 5.5.3 Sorting and disassembly
- 5.5.4 Cleaning [Go to Page]
- 5.5.4.1 General
- 5.5.4.2 Cleaning agents
- 5.5.4.3 Methods of cleaning [Go to Page]
- 5.5.4.3.1 Selection of an appropriate method
- 5.5.4.3.2 Manual cleaning
- 5.5.4.3.3 Mechanical cleaning
- 5.5.4.4 Instrument cleaning
- 5.5.4.5 Utensil cleaning
- 5.5.4.6 Verification of cleaning effectiveness
- 5.5.5 Microbicidal processes
- 5.6 Selection of packaging materials
- 5.7 Sterilization of packaged items [Go to Page]
- 5.7.1 Preparation of items to be sterilized
- 5.7.2 Loading the sterilizer
- 5.7.3 Equipment operation
- 5.7.4 Sterilization cycle parameters
- 5.7.5 Unloading the sterilizer [Go to Page]
- 5.7.5.1 Removing items from the sterilizer
- 5.7.5.2 Cooling
- 5.7.5.3 Handling and inspection
- 5.7.6 User safety factors
- 5.7.7 Common operator errors
- 5.8 Sterilization of unwrapped items [Go to Page]
- 5.8.1 General considerations
- 5.8.2 Preparation of unwrapped items
- 5.8.3 Cycle parameters for unwrapped items
- 5.8.4 Unloading the sterilizer
- 5.9 Sterile storage of packaged items [Go to Page]
- 5.9.1 Dust covers
- 5.9.2 Storage environment
- 5.9.3 Storage shelving
- 5.9.4 Shelf life
- 5.10 Distribution [Go to Page]
- 5.10.1 Handling and inspection
- 5.10.2 Distribution containers and cassettes
- 6 Installation, care, and maintenance of sterilizers [Go to Page]
- 6.1 General rationale
- 6.2 Instruction manuals
- 6.3 Installation
- 6.4 Routine care and maintenance
- 6.5 Repair and component replacement
- 6.6 Calibration
- 6.7 Recordkeeping
- 7 Quality control [Go to Page]
- 7.1 General rationale
- 7.2 Product identification and traceability [Go to Page]
- 7.2.1 Lot control numbers
- 7.2.2 Sterilizer records
- 7.2.3 Expiration dating
- 7.3 Physical monitoring [Go to Page]
- 7.3.1 Use of physical monitors
- 7.3.2 Sterilizer malfunction
- 7.4 Chemical indicators [Go to Page]
- 7.4.1 Definition
- 7.4.2 Selecting chemical indicators
- 7.4.3 Using chemical indicators [Go to Page]
- 7.4.3.1 External chemical indicators
- 7.4.3.2 Internal chemical indicators [Go to Page]
- 7.4.3.2.1 Placement and frequency of use
- 7.4.3.2.2 Retrieval and interpretation
- 7.4.3.2.3 Nonresponsive or inconclusive chemical indicators
- 7.5 Biological indicators [Go to Page]
- 7.5.1 Definition
- 7.5.2 Selecting biological indicators
- 7.5.3 Frequency of use of biological indicators
- 7.6 Sterilizer efficacy testing [Go to Page]
- 7.6.1General considerations
- 7.6.2Construction of the PCD
- 7.6.3Placement of the PCD
- 7.6.4Test procedure
- 7.6.5Acceptance criteria [Go to Page]
- 7.6.5.1Qualification testing
- 7.6.5.2Routine biological monitoring
- 7.6.6Positive BI results
- 7.6.7Microbiological testing [Go to Page]
- 7.6.7.1General considerations
- 7.6.7.2Test procedure
- 7.6.7.3Interpretation of results
- 7.7 Periodic product monitoring
- 7.8 Product recalls [Go to Page]
- 7.8.1 Policies and procedures
- 7.8.2 Recall procedure
- 7.8.3 Recall order
- 7.8.4 Recall report
- 7.9 Third-party services
- Annex A The science of dry heat sterilization [Go to Page]
- A.1 Historical perspective on dry heat sterilization
- A.2 How dry heat (heated air) sterilization is accomplished
- A.3 Types of dry heat sterilizers
- A.4 Variables associated with the dry heat sterilization process
- A.5 How dry heat sterilization is measured [Go to Page]
- A.5.1 Microbial destruction
- A.5.2 Indirect measurement
- A.5.3 Direct measurement
- A.6 Typical items sterilized by dry heat
- Annex B User verification of cleaning processes [Go to Page]
- B.1 General considerations
- B.2 Markers
- B.3 Cleaning verification tests for users
- Annex C Example of documentation of premature release of implants
- Annex D Bibliography
- Blank Page [Go to Page]