{"id":430045,"date":"2024-10-20T07:21:23","date_gmt":"2024-10-20T07:21:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-st79-2017-ra2022\/"},"modified":"2024-10-26T14:00:02","modified_gmt":"2024-10-26T14:00:02","slug":"aami-st79-2017-ra2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-st79-2017-ra2022\/","title":{"rendered":"AAMI ST79 2017 RA2022"},"content":{"rendered":"

ST79 is THE go-to reference for steam sterilization and sterility assurance in all healthcare facilities, regardless of sterilizer or facility size. Developed by industry experts, regulators, and sterilization professionals, ST79:2017 will guide you through every step of the steam sterilization process. This comprehensive guide encompasses cleaning, transport, quality monitoring, storage, product evaluation, equipment maintenance, personnel considerations, and steam sterilization in all health care facilities, including, but not limited to, hospitals, ambulatory surgery facilities, physicians’ offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, dental offices, and other areas where sterile products are reprocessed, stored, and used. Use ST79:2017, the best available guidance for steam sterilization and sterility assurance, to help you stay in compliance with accrediting bodies. The following amendments to ST79:2017 are included in this document: Amendment 1: Environmental services\/fans\/food and drink; Amendment 2: Inspection of insulated instruments; Amendment 3: Modification of content pertaining to frequency of cleaning for routine care of sterilizers for sterile processing areas in health care facilities; and Amendment 4: Content addressing recording B1 lot numbers in sterilizer records for sterile processing in health care facilities.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI ST79:2017\/(R)2022 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Recommended practice
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
11<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
12<\/td>\nCommittee representation <\/td>\n<\/tr>\n
15<\/td>\nForeword <\/td>\n<\/tr>\n
17<\/td>\nIntroduction: Need for the recommended practice <\/td>\n<\/tr>\n
18<\/td>\nSteam sterilization in office-based, ambulatory-care medical, surgical, and dental facilities <\/td>\n<\/tr>\n
19<\/td>\n1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions <\/td>\n<\/tr>\n
20<\/td>\n2 Definitions and abbreviations <\/td>\n<\/tr>\n
28<\/td>\n3 Design considerations
3.1 General considerations
3.2 Work area design and functional workflow
3.2.1 Design criteria
3.2.1.1 General considerations <\/td>\n<\/tr>\n
29<\/td>\n3.2.1.2 Decontamination area\/room <\/td>\n<\/tr>\n
30<\/td>\n3.2.2 Functional workflow patterns <\/td>\n<\/tr>\n
31<\/td>\n3.2.3 Traffic control <\/td>\n<\/tr>\n
32<\/td>\nFigure 1\u2014Workflow <\/td>\n<\/tr>\n
33<\/td>\n3.3 Utilities
3.3.1 Mechanical systems
3.3.2 Electrical systems
3.3.3 Steam for sterile processing
3.3.3.1 General considerations
3.3.3.2 Steam quality <\/td>\n<\/tr>\n
34<\/td>\n3.3.3.3 Steam purity
3.3.3.4 Monitoring steam systems
3.3.4 Utility monitoring and alarm systems
3.3.5 General facility design requirements
3.3.5.1 Floors <\/td>\n<\/tr>\n
35<\/td>\n3.3.5.2 Walls
3.3.5.3 Ceilings
3.3.5.4 Doors
3.3.5.5 Heating, ventilation, and air conditioning (HVAC) operating parameters <\/td>\n<\/tr>\n
36<\/td>\n3.3.5.6 Lighting
Table 1\u2014IES-recommended illuminance levels for work environments
3.3.5.7 Handwashing stations <\/td>\n<\/tr>\n
37<\/td>\n3.3.6 Special area requirements and restrictions
3.3.6.1 Decontamination area\/room
3.3.6.1.1 Design considerations
3.3.6.1.2 Space considerations <\/td>\n<\/tr>\n
38<\/td>\n3.3.6.1.3 Ergonomic considerations
3.3.6.2 Clean work area\/room <\/td>\n<\/tr>\n
39<\/td>\n3.3.6.3 Sterilization area
3.3.6.4 Sterile storage <\/td>\n<\/tr>\n
40<\/td>\n3.3.6.5 Breakout area\/room
3.3.7 Emergency eyewash\/shower equipment <\/td>\n<\/tr>\n
41<\/td>\n4 Personnel considerations
4.1 General considerations
4.2 Qualifications
4.2.1 Supervisory personnel
4.2.2 Sterile processing personnel <\/td>\n<\/tr>\n
42<\/td>\n4.3 Education and training
4.3.1 Sterile processing personnel
4.3.2 Service personnel <\/td>\n<\/tr>\n
43<\/td>\n4.3.3 Other personnel
4.4 Health and personal hygiene
4.5 Attire
4.5.1 General considerations <\/td>\n<\/tr>\n
44<\/td>\n4.5.2 Decontamination area\/room <\/td>\n<\/tr>\n
45<\/td>\n4.6 Standard and transmission-based precautions <\/td>\n<\/tr>\n
46<\/td>\n5 Receiving
5.1 General considerations
5.2 Receiving of purchased or loaned items
5.2.1 General considerations
5.2.2 New, repaired, and refurbished reusable items
5.2.3 Loaned or borrowed instrumentation <\/td>\n<\/tr>\n
47<\/td>\n5.2.4 Rigid sterilization container systems <\/td>\n<\/tr>\n
48<\/td>\n5.2.5 Disposable items
5.3 Disposition of sterile items (issued but not used) <\/td>\n<\/tr>\n
49<\/td>\n6 Handling, collection, and transport of contaminated items
6.1 General considerations
6.2 Separation of waste and reusable items at point of use <\/td>\n<\/tr>\n
50<\/td>\n6.3 Point-of-use care and handling of contaminated reusable items
6.3.1 Handling of instruments during surgical procedure
6.3.2 Removal of gross soil
6.3.3 Instruments opened but not used
6.3.4 Disassembly of instruments
6.3.5 Prevention of instrument damage <\/td>\n<\/tr>\n
51<\/td>\n6.4 Containment <\/td>\n<\/tr>\n
52<\/td>\n6.5 Transport
6.5.1 Segregation of clean\/sterile items
6.5.2 Transportation scheduling and routes
6.5.3 Transportation equipment
6.5.4 Hand transport <\/td>\n<\/tr>\n
53<\/td>\n6.5.5 Dedicated lifts
6.5.6 Transport between buildings
6.5.7 Off-site transportation <\/td>\n<\/tr>\n
55<\/td>\n7 Cleaning, disinfection (microbicidal processes), and other decontamination steps
7.1 General considerations
7.2 Policies and procedures <\/td>\n<\/tr>\n
56<\/td>\n7.3 Manufacturer\u2019s written IFU
7.4 Decontamination
7.4.1 General considerations for all devices and utensils <\/td>\n<\/tr>\n
57<\/td>\n7.4.2 Special considerations
7.4.2.1 Reusable textiles
7.4.2.2 Instrument lubricants
7.5 Preparation for cleaning
7.5.1 Presoaking
7.5.2 Sorting and disassembly
7.5.2.1 General considerations <\/td>\n<\/tr>\n
58<\/td>\n7.5.2.2 Rigid sterilization container systems
7.5.2.2.1 General considerations
7.5.2.2.2 Removable filters
7.5.2.2.3 Valves <\/td>\n<\/tr>\n
59<\/td>\n7.5.2.2.4 Interior baskets
7.5.2.2.5 Process indicators, disposable labels, and disposable locks
7.5.2.2.6 Container accessories
7.6 Cleaning
7.6.1 General considerations <\/td>\n<\/tr>\n
60<\/td>\n7.6.2 Devices with lumens
7.6.3 Cleaning agents
7.6.4 Methods of cleaning
7.6.4.1 Selection of an appropriate method <\/td>\n<\/tr>\n
61<\/td>\n7.6.4.2 Manual cleaning
7.6.4.3 Mechanical cleaning, disinfection, and other decontamination steps
7.6.4.3.1 General considerations
7.6.4.3.2 Maintenance of mechanical cleaning and disinfection equipment <\/td>\n<\/tr>\n
62<\/td>\n7.6.4.3.3 Selection of mechanical cleaning and disinfection equipment
7.6.4.3.4 Loading mechanical cleaning and disinfection equipment <\/td>\n<\/tr>\n
63<\/td>\n7.6.4.3.5 Unloading mechanical cleaning and disinfection equipment
7.6.4.4 Ultrasonic cleaning equipment
7.6.4.4.1 General considerations <\/td>\n<\/tr>\n
64<\/td>\n7.6.4.4.2 Loading
7.6.4.4.3 Unloading
7.6.4.5 Verification of the cleaning process <\/td>\n<\/tr>\n
66<\/td>\n8 Preparation and assembly of instruments
8.1 General considerations
8.2 Instruments <\/td>\n<\/tr>\n
67<\/td>\n8.3 Devices with lumens
8.4 Basins and basin sets
8.5 Textile packs <\/td>\n<\/tr>\n
68<\/td>\n9 Packaging
9.1 General considerations
9.2 Selection of sterile barrier systems
9.3 Package labeling <\/td>\n<\/tr>\n
69<\/td>\n9.4 Package closures
9.5 Sterilization wrap
9.5.1 General considerations
9.5.2 Woven wraps
9.5.3 Nonwoven wraps <\/td>\n<\/tr>\n
70<\/td>\n9.5.4 Paper\u2013plastic pouches
Figure 2\u2014Example of single- and double-packaging with paper\u2013plastic pouches <\/td>\n<\/tr>\n
71<\/td>\n9.6 Wrapping techniques
9.6.1 Simultaneous double-wrapping: envelope fold
Figure 3\u2014Simultaneous double-wrapping: envelope fold <\/td>\n<\/tr>\n
72<\/td>\n9.6.2 Simultaneous double-wrapping: square fold
Figure 4\u2014Simultaneous double-wrapping: square fold <\/td>\n<\/tr>\n
73<\/td>\n9.6.3 Sequential wrapping: envelope fold
Figure 5\u2014Sequential wrapping: envelope fold <\/td>\n<\/tr>\n
74<\/td>\n9.6.4 Sequential wrapping: square fold
Figure 6\u2014Sequential wrapping: square fold <\/td>\n<\/tr>\n
75<\/td>\n9.7 Sterility maintenance covers
9.8 Rigid sterilization container systems <\/td>\n<\/tr>\n
77<\/td>\n10 Sterilization
10.1 Loading the sterilizer
10.1.1 General considerations
10.1.2 Paper\u2013plastic pouches
10.1.3 Instrument sets
10.1.4 Textile packs
10.1.5 Utensils and glassware <\/td>\n<\/tr>\n
78<\/td>\nFigure 7\u2014Examples of sterilizer cart loads
10.1.6 Rigid sterilization container systems
10.1.7 Liquids <\/td>\n<\/tr>\n
79<\/td>\n10.1.8 Powders and oils
10.2 Sterilization parameters
10.2.1 General considerations
10.2.2 Sterilization cycles
10.2.2.1 Sterilization cycles and accessories
10.2.3 Immediate-use steam sterilization <\/td>\n<\/tr>\n
80<\/td>\n10.3 Unloading the sterilizer
10.3.1 Unloading sterilizers having a chamber volume larger than 2 cubic feet
10.3.2 Unloading table-top sterilizers (sterilizers having a chamber volume of less than or equal to 2 cubic feet) <\/td>\n<\/tr>\n
81<\/td>\n10.4 Handling and inspection after unloading the sterilizer <\/td>\n<\/tr>\n
82<\/td>\n11 Storage and transportation
11.1 Sterile storage
11.1.1 Storage facilities
11.1.2 Sterility maintenance covers
11.1.3 Shelf life <\/td>\n<\/tr>\n
83<\/td>\n11.2 Distribution
11.2.1 Handling and inspection
11.2.2 Distribution containers
11.3 Transport of sterile packaged items
11.3.1 General considerations
11.3.2 Tables and carts (open or closed)
11.3.3 Hand transport <\/td>\n<\/tr>\n
84<\/td>\n11.3.4 Dedicated lifts
11.3.5 Off-site transportation <\/td>\n<\/tr>\n
85<\/td>\n12 Installation, care, and maintenance of sterilizers
12.1 General rationale
12.2 Instruction manuals
12.3 Installation
12.4 Routine care <\/td>\n<\/tr>\n
86<\/td>\n12.5 Preventive maintenance
12.5.1 General considerations
12.5.2 Scheduled maintenance
12.6 Calibration
12.7 Record-keeping <\/td>\n<\/tr>\n
88<\/td>\n13 Process monitoring, testing, and quality control
13.1 General considerations
13.2 Monitoring of mechanical cleaning equipment
13.3 Product identification and traceability
13.3.1 General considerations
13.3.2 Package labeling and expiration dating, if applicable <\/td>\n<\/tr>\n
89<\/td>\n13.3.3 Sterilizer records
13.3.4 Record retention
13.4 Sterilization process monitoring <\/td>\n<\/tr>\n
91<\/td>\nTable 2\u2014Sterilization process monitoring recommendations <\/td>\n<\/tr>\n
92<\/td>\nTable 3\u2014Types and applications for use of sterilization monitoring devices <\/td>\n<\/tr>\n
93<\/td>\n13.5 Sterilization process monitoring devices
13.5.1 Physical monitors
13.5.2 Chemical indicators
13.5.2.1 General considerations <\/td>\n<\/tr>\n
95<\/td>\n13.5.2.2 Using chemical indicators
13.5.2.2.1 External chemical indicators
13.5.2.2.2 Internal chemical indicators <\/td>\n<\/tr>\n
96<\/td>\n13.5.3 Biological indicators
13.5.3.1 General considerations
13.5.3.2 Using biological indicators <\/td>\n<\/tr>\n
97<\/td>\n13.5.4 Process challenge devices <\/td>\n<\/tr>\n
98<\/td>\n13.6 Routine load release
13.6.1 Process monitoring devices
13.6.2 Release criteria for nonimplants
13.6.3 Release criteria for implants <\/td>\n<\/tr>\n
99<\/td>\n13.6.4 Sterilization process failure <\/td>\n<\/tr>\n
100<\/td>\n13.7 Routine sterilizer efficacy monitoring
13.7.1 General considerations
13.7.2 Routine biological monitoring of sterilizers larger than 2 cubic feet
13.7.2.1 General considerations
13.7.2.2 Composition of the user-assembled PCD
13.7.2.3 Placement of the PCD <\/td>\n<\/tr>\n
101<\/td>\nFigure 8\u2014Preparation of the 16 towel PCD (BI challenge test pack) <\/td>\n<\/tr>\n
102<\/td>\nFigure 9\u2014Placement of the 16 towel PCD (BI challenge test pack) forroutine biological monitoring of sterilizers larger than 2 cubic feet
13.7.2.4 Test procedure
13.7.2.5 Acceptance criteria <\/td>\n<\/tr>\n
103<\/td>\n13.7.3 Routine biological monitoring of table-top sterilizers (less than or equal to 2 cubic feet)
13.7.3.1 Composition of the PCD
13.7.3.2 Placement of the PCD
13.7.3.3 Test procedure <\/td>\n<\/tr>\n
104<\/td>\n13.7.3.4 Acceptance criteria
13.7.4 Routine biological sterilizer efficacy monitoring of gravity-displacement cycles
13.7.4.1 Composition of the PCD
13.7.4.2 Placement of the PCD
13.7.4.3 Test procedure <\/td>\n<\/tr>\n
105<\/td>\n13.7.4.4 Acceptance criteria
13.7.5 Actions to take when BIs, CIs, or physical monitors indicate a sterilization process failure
13.7.5.1 General procedure
13.7.5.2 Recall of items processed by the health care facility
13.7.5.2.1 General considerations <\/td>\n<\/tr>\n
106<\/td>\n13.7.5.2.2 Recall procedure
13.7.5.2.3 Recall report
13.7.5.3 Microbiological testing <\/td>\n<\/tr>\n
107<\/td>\nFigure 10\u2014Decision tree for conducting investigations of steam sterilization processfailures <\/td>\n<\/tr>\n
108<\/td>\nTable 4\u2014Potential causes to be investigated for steam sterilization process failures <\/td>\n<\/tr>\n
110<\/td>\n13.7.6 Routine Bowie-Dick testing of dynamic-air-removal sterilizers
13.7.6.1 General considerations
13.7.6.2 Composition of the Bowie-Dick test pack <\/td>\n<\/tr>\n
111<\/td>\nFigure 11\u2014Composition of the Bowie-Dick test pack
13.7.6.3 Placement of the Bowie-Dick test pack
13.7.6.4 Test procedure
13.7.6.5 Acceptance criteria <\/td>\n<\/tr>\n
112<\/td>\nFigure 12\u2014Placement of the Bowie-Dick test pack <\/td>\n<\/tr>\n
113<\/td>\n13.8 Qualification testing
13.8.1 General considerations
13.8.2 Qualification testing of sterilizers have a chamber volume larger than 2 cubic feet
13.8.2.1 Composition of the PCD <\/td>\n<\/tr>\n
114<\/td>\n13.8.2.2 Placement of the PCD
13.8.2.3 BI PCD test procedure
13.8.2.4 Acceptance criteria <\/td>\n<\/tr>\n
115<\/td>\nFigure 13\u2014Placement of the 16 towel PCD (BI challenge test pack) for qualification testing
13.8.3 Qualification testing of table-top sterilizers (sterilizers having a chamber volume less than or equal to 2 cubic feet)
13.8.3.1 Composition of the PCD
13.8.3.2 Placement of the PCD <\/td>\n<\/tr>\n
116<\/td>\n13.8.3.3 Test procedure
13.8.3.4 Acceptance criteria
13.8.4 Qualification testing of IUSS cycles
13.8.4.1 Composition of the PCD <\/td>\n<\/tr>\n
117<\/td>\n13.8.4.2 Placement of the PCD
13.8.4.3 Test procedure
13.8.4.4 Acceptance criteria
13.9 Periodic product quality assurance testing of routinely processed items
13.9.1 General considerations <\/td>\n<\/tr>\n
118<\/td>\n13.9.2 Process verification
13.9.3 Product families <\/td>\n<\/tr>\n
119<\/td>\n13.9.4 Verification testing procedure <\/td>\n<\/tr>\n
120<\/td>\n13.10 Periodic product quality assurance testing of rigid sterilization container systems
13.10.1 General considerations
13.10.2 User responsibilities
13.10.2.1 General considerations
13.10.2.2 Prepurchase evaluation
13.10.2.2.1 General
13.10.2.2.2 Performance verification under conditions of use <\/td>\n<\/tr>\n
121<\/td>\n13.10.2.2.3 Prepurchase evaluation test protocols
Table 5\u2014Summary of test configurations for prepurchaseevaluation of rigid sterilization container systems <\/td>\n<\/tr>\n
122<\/td>\n14 Quality process improvement
14.1 General considerations
14.2 Quality process
14.2.1 General considerations
14.2.2 Quality system model <\/td>\n<\/tr>\n
123<\/td>\n14.2.3 Risk analysis
14.2.3.1 General considerations
14.2.3.2 Design
14.2.3.3 Decontamination <\/td>\n<\/tr>\n
124<\/td>\n14.2.3.4 Personnel
14.2.3.5 Handling of contaminated items
14.2.3.6 Packaging <\/td>\n<\/tr>\n
125<\/td>\n14.2.3.7 Sterilizer loading and unloading
14.2.3.8 Immediate-use steam sterilization
14.2.3.9 Sterility maintenance <\/td>\n<\/tr>\n
126<\/td>\n14.2.3.10 Problem investigation
14.3 Supplier communication
14.4 Repair records
14.5 Processing policies and procedures <\/td>\n<\/tr>\n
127<\/td>\n15 New product evaluation
15.1 General rationale
15.2 Considerations <\/td>\n<\/tr>\n
128<\/td>\nAnnex A
\n(informative) Examples of workplace design
Figure A.1\u2014Example of a work area design and workflow patternfor a sterile processing area in a typical small hospital <\/td>\n<\/tr>\n
129<\/td>\nFigure A.2\u2014Example of a work area design and workflow pattern for a sterile processing area in a typical medium-sized hospital <\/td>\n<\/tr>\n
130<\/td>\nFigure A.3\u2014Example of a work area design and workflow pattern for a sterile processing area in a typical regional processing center <\/td>\n<\/tr>\n
131<\/td>\nFigure A.4\u2014Example of an ambulatory surgery facility <\/td>\n<\/tr>\n
132<\/td>\nFigure A.5\u2014Example of a dental facility <\/td>\n<\/tr>\n
133<\/td>\nAnnex B
\n(informative) Infection transmission and standard precautions
B.1 Introduction
Figure B.1\u2014The chain of infection, components of the infectious disease process
B.2 Chain of infection <\/td>\n<\/tr>\n
134<\/td>\nB.2.1 Etiologic agent
B.2.1.1 General
B.2.1.2 Pathogenicity
B.2.1.3 Dose
B.2.2 Reservoir
B.2.3 Portal of exit <\/td>\n<\/tr>\n
135<\/td>\nFigure B.2\u2014Blood-borne pathogen strike-through conversion chart
B.2.4 Mode of transmission <\/td>\n<\/tr>\n
136<\/td>\nB.2.5 Portal of entry
B.2.6 Susceptible host
B.3 Barrier protection and protective clothing <\/td>\n<\/tr>\n
137<\/td>\nAnnex C
\n(informative) Processing CJD-contaminated patient care equipment and environmental surfaces
C.1 Introduction <\/td>\n<\/tr>\n
140<\/td>\nC.2 Processing devices contaminated with high-risk tissue <\/td>\n<\/tr>\n
141<\/td>\nC.3 Processing devices contaminated with low-risk tissue
C.4 Processing devices contaminated with no-risk tissue
C.5 Update of recommendations <\/td>\n<\/tr>\n
142<\/td>\nAnnex D
\n(informative) User verification of cleaning processes
D.1 General considerations <\/td>\n<\/tr>\n
143<\/td>\nD.2 Markers
D.3 Cleaning verification tests for users <\/td>\n<\/tr>\n
145<\/td>\nAnnex E
\n(informative) Selection and use of chemical disinfectants
E.1 Introduction
E.2 Categories of items to be disinfected <\/td>\n<\/tr>\n
146<\/td>\nE.3 Activity levels of disinfectants
E.4 Labeling of disinfectant products <\/td>\n<\/tr>\n
147<\/td>\nTable E.1\u2014Levels of disinfection according to type of microorganism
E.5 Criteria for selecting a chemical disinfectant <\/td>\n<\/tr>\n
148<\/td>\nE.6 Quality control in chemical disinfection <\/td>\n<\/tr>\n
149<\/td>\nE.7 Safety considerations in chemical disinfection <\/td>\n<\/tr>\n
150<\/td>\nTable E.2\u2014Occupational exposure limits for some chemical sterilants and disinfectants <\/td>\n<\/tr>\n
151<\/td>\nAnnex F
\n(informative) Thermal disinfection
F.1 Introduction
F.2 Microbial destruction by heat
F.3 Items suitable for thermal disinfection
F.4 Manufacturers\u2019 written IFU
F.5 Quality control in thermal disinfection
F.6 Safety considerations in thermal disinfection <\/td>\n<\/tr>\n
152<\/td>\nAnnex G
\n(informative) Devices returned to the manufacturer
G.1 Introduction
G.2 Overview
G.3 Manufacturer\u2019s instructions to the user <\/td>\n<\/tr>\n
153<\/td>\nG.4 User responsibilities
G.4.1 General
G.4.2 Decontamination at the health care facility
G.4.3 Packaging, labeling, and shipment to the manufacturer\u2019s facility
G.4.3.1 General considerations
G.4.3.2 Postal regulations <\/td>\n<\/tr>\n
154<\/td>\nG.4.3.3 DOT regulations
G.5 Receiving at the manufacturer\u2019s facility <\/td>\n<\/tr>\n
155<\/td>\nG.6 Cleaning, decontamination, and sterilization methods at the manufacturer\u2019s facility
G.7 Personal protective equipment at the manufacturer\u2019s facility
G.8 Work practices for infection prevention and control at the manufacturer\u2019s facility <\/td>\n<\/tr>\n
156<\/td>\nG.9 Housekeeping and waste disposal <\/td>\n<\/tr>\n
157<\/td>\nG.10 Device failure investigation
G.11 Documentation to the user <\/td>\n<\/tr>\n
158<\/td>\nAnnex H
\n(informative) Development of a prepurchase evaluation protocol for rigid sterilization container systems
H.1 Introduction <\/td>\n<\/tr>\n
159<\/td>\nH.2 General considerations
H.3 Instruments and devices to be containerized
H.4 Cleaning and decontamination considerations <\/td>\n<\/tr>\n
160<\/td>\nH.5 Preparation and assembly considerations
H.6 Matching the rigid sterilization container system and sterilization cycle
H.7 Loading the sterilizer <\/td>\n<\/tr>\n
161<\/td>\nH.8 Choosing the appropriate exposure and drying times
H.9 Unloading the sterilizer and cooling the load
H.10 Sterility maintenance <\/td>\n<\/tr>\n
162<\/td>\nH.12 Transportation
H.13 Aseptic presentation
H.14 Conclusion <\/td>\n<\/tr>\n
163<\/td>\nAnnex I
\n(informative) Effect of container systems on load come-up time
Figure I.1\u2014Typical rigid sterilization container system processedin a gravity-displacement cycle at 121\u00b0C (250\u00b0F) <\/td>\n<\/tr>\n
164<\/td>\nFigure I.2\u2014Muslin-wrapped, 16 pound instrument set processed in agravity-displacement cycle at 121\u00b0C (250\u00b0F)
Figure I.3\u2014Typical rigid sterilization container system processed in a prevacuum cycle at 132\u00b0C (270\u00b0F) <\/td>\n<\/tr>\n
165<\/td>\nAnnex J
\n(informative) Development and qualification of the 16 towel PCD (biological-indicator challenge test pack)
J.1 Introduction
J.2 Survey and preliminary testing <\/td>\n<\/tr>\n
166<\/td>\nTable J.1\u201416 towel pack survey <\/td>\n<\/tr>\n
167<\/td>\nFigure J.1\u2014Temperature profiles for two different configurations of 12 \u00d7 12 \u00d7 20 inch packsin a 121\u00b0C (250\u00b0F) gravity-displacement cycle
Figure J.2\u2014Temperature profiles for huck and absorbent 16 towel packs in a 121\u00b0C (250\u00b0F) gravity-displacement cycle
J.3 Validation testing in gravity-displacement cycles <\/td>\n<\/tr>\n
168<\/td>\nTable J.2\u2014Biological-indicator results from 121\u00b0C (250\u00b0F) gravity-displacement cycle
Figure J.3\u2014Average temperature profile for the 16 towel pack in a 121\u00b0C (250\u00b0F) gravity-displacement cycle
J.4 Validation testing in prevacuum cycles <\/td>\n<\/tr>\n
169<\/td>\nTable J.3\u2014Biological-indicator results from 132\u00b0C (270\u00b0F) deep-vacuum cycle
Table J.4\u2014Biological-indicator results from 132\u00b0C (270\u00b0F) pulsing vacuum cycle
J.5 Direct comparison of the 12 ( 12 ( 20 inch and 16 towel test packs <\/td>\n<\/tr>\n
170<\/td>\nTable J.5\u2014Comparison of the 16 towel pack with the12 \u00d7 12 \u00d7 20 inch pack by Most Probable Number and sterility assessment of spore strips (121\u00b0C [250\u00b0F] gravity-displacement cycle)
Table J.6\u2014Fraction-negative results in a 121\u00b0C (250\u00b0F) gravity-displacement cycle <\/td>\n<\/tr>\n
171<\/td>\nJ.6 Summary of round-robin testing
J.7 Supplemental data for steam-flush pressure-pulsing cycles
Table J.7\u2014Biological-indicator results from 121\u00b0C (250\u00b0F)steam-flush pressure-pulse cycle
Table J.8\u2014Biological-indicator results from 132\u00b0C (270\u00b0F)steam-flush pressure-pulse cycle <\/td>\n<\/tr>\n
172<\/td>\nAnnex K
\n(informative) Documentation of emergency release of sterilizer loads
Figure K.1\u2014Exception form for emergency release of sterilizer load <\/td>\n<\/tr>\n
173<\/td>\nAnnex L
\n(informative) Steam quality
L.1 Introduction
L.2 General considerations
L.3 Steam dryness <\/td>\n<\/tr>\n
174<\/td>\nL.4 Noncondensable gases <\/td>\n<\/tr>\n
175<\/td>\nAnnex M
\n(informative) Toxic anterior segment syndrome (TASS) and the processing of intraocular surgical instruments
M.1 Introduction
M.2 Processing recommendations
M.2.1 General considerations
M.2.2 Important elements of a processing program for intraocular surgical instruments
M.2.2.1 Instrument inventory
M.2.2.2 Designated cleaning area and equipment <\/td>\n<\/tr>\n
176<\/td>\nM.2.2.3 Manufacturer\u2019s instructions
M.2.2.4 Precleaning
M.2.2.5 Transport of instruments to the decontamination area
M.2.2.6 Personal protective equipment
M.2.2.7 Cleaning agents
M.2.2.8 Sterilization
M.2.2.9 Maintenance of processing equipment <\/td>\n<\/tr>\n
177<\/td>\nM.3 Resources and training
M.4 Summary <\/td>\n<\/tr>\n
178<\/td>\nAnnex N
\n(informative) Comparison of the differences between AAMI and FDA classifications of chemical indicators
N.1 Introduction
N.2 History
N.3 FDA recognition of a consensus standard <\/td>\n<\/tr>\n
179<\/td>\nN.4 Types of chemical indicators defined in ANSI\/AAMI\/ISO 11140-1 vs. the FDA guidance document <\/td>\n<\/tr>\n
181<\/td>\nTable N.1\u2014Comparison of terminology and differences between performance requirements ofANSI\/AAMI\/ISO 11140-1 and FDA (2003) guidance recommendations <\/td>\n<\/tr>\n
182<\/td>\nAnnex O
\n(informative) Moisture assessment <\/td>\n<\/tr>\n
183<\/td>\nTable O.1\u2014Moisture assessment check list <\/td>\n<\/tr>\n
186<\/td>\nFigure O.1\u2014Moisture assessment flow chart <\/td>\n<\/tr>\n
187<\/td>\nAnnex P
\n(informative) General considerations for cleaning and disinfection\u2028
P.1 Introduction
P.2 Mechanical (automated) cleaning and disinfection
P.2.1 General considerations <\/td>\n<\/tr>\n
188<\/td>\nP.2.2 Ultrasonic cleaning equipment
P.2.2.1 Overview
P.2.2.2 Basic ultrasonic washers
P.2.2.3 Ultrasonic irrigators \u2028
P.2.2.4 Ultrasonic irrigator washers \u2028 <\/td>\n<\/tr>\n
189<\/td>\nP.2.2.5 Ultrasonic irrigator washer\u2013disinfectors
P.2.3 Washer\u2013pasteurizers
P.2.4 Washer\u2013disinfectors
P.2.4.1 Overview <\/td>\n<\/tr>\n
190<\/td>\nP.2.4.2 Single-chamber washer\u2013disinfectors
P.2.4.3 Multi-chamber washer\u2013disinfectors
P.2.4.4 Cart washers <\/td>\n<\/tr>\n
191<\/td>\nAnnex Q
\n(informative) Alternatives for keeping cool in the sterile processing environment
Q.1 Introduction
Q.2 Decontamination environment
Q.3 Protective attire <\/td>\n<\/tr>\n
192<\/td>\nQ.4 Alternative cooling methods for personnel working in the decontamination area\/room <\/td>\n<\/tr>\n
193<\/td>\nBibliography <\/td>\n<\/tr>\n
203<\/td>\nANSI\/AAMI ST79:2017\/A1:2020 <\/td>\n<\/tr>\n
204<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
205<\/td>\nContents Page <\/td>\n<\/tr>\n
206<\/td>\nCommittee representation <\/td>\n<\/tr>\n
210<\/td>\nForeword <\/td>\n<\/tr>\n
211<\/td>\n1 Revise content in 3.2.1.1
1.1 General considerations: change header, revise 1st paragraph: Add NOTE and Rationale. <\/td>\n<\/tr>\n
212<\/td>\nFigure 1\uf8e7Example of environmental cleaning checklist <\/td>\n<\/tr>\n
213<\/td>\n2 Revise content in 3.3.5.5
2.1 Heating, ventilation, and air conditioning (HVAC) operating parameters: Add a new 2nd paragraph and additional content for the Rationale <\/td>\n<\/tr>\n
215<\/td>\nANSI\/AAMI ST79:2017\/A2:2020 <\/td>\n<\/tr>\n
216<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
217<\/td>\nContents Page <\/td>\n<\/tr>\n
218<\/td>\nCommittee representation <\/td>\n<\/tr>\n
222<\/td>\nForeword <\/td>\n<\/tr>\n
223<\/td>\n1 Add new sections 8.2 and 8.2.1
1.1 Change the subsequent numbering of this section; add new related references to Bibliography. <\/td>\n<\/tr>\n
224<\/td>\nTable 1\uf8e7Inspection points and possible damage for various instruments\/devices <\/td>\n<\/tr>\n
225<\/td>\nFigure 1\uf8e7Laparoscopic instrumentation: examples of collar not flush against distal working mechanism
Figure 2\uf8e7Laparoscopic instrumentation: examples of shaft and handle nicks, cracks, lacerations, gouges, and microscopic pin holes <\/td>\n<\/tr>\n
226<\/td>\nFigure 3\uf8e7Insulated forceps: examples of frays at distal tip, lacerations, housing cracksFigure
Figure 4\uf8e7Cables\/cords: examples of separation of the cord at the proximal end, nicks, lacerations, pin holes <\/td>\n<\/tr>\n
227<\/td>\nFigure 5\uf8e7LEEP and miscellaneous insulated coated instruments\/devices: examples of nicks, lacerations, gouges, pin holes
2 Add to Bibliography <\/td>\n<\/tr>\n
229<\/td>\nANSI\/AAMI ST79:2017\/A3:2020 <\/td>\n<\/tr>\n
230<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
232<\/td>\nCommittee representation <\/td>\n<\/tr>\n
236<\/td>\nForeword <\/td>\n<\/tr>\n
237<\/td>\n1 Revise section 12.4
1.1 Eliminate daily cleaning recommendation. <\/td>\n<\/tr>\n
239<\/td>\nANSI\/AAMI ST79:2017\/A4:2020 <\/td>\n<\/tr>\n
240<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
242<\/td>\nCommittee representation <\/td>\n<\/tr>\n
246<\/td>\nForeword <\/td>\n<\/tr>\n
247<\/td>\n1 Revise section 13.3.3
1.1 Add content pertaining to lot numbers.
2 Revise section 13.8.2.3 6) to read:
3 Revise section 13.8.3.3 6) to read: <\/td>\n<\/tr>\n
248<\/td>\n4 Revise section 13.8.4.3 e) to read: <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI ST79:2017\/(R)2022 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n248<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":430051,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-430045","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/430045","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/430051"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=430045"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=430045"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=430045"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}