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.

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1	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
3	Title page
4	AAMI Recommended practice Copyright information
5	Contents
11	Glossary of equivalent standards
12	Committee representation
15	Foreword
17	Introduction: Need for the recommended practice
18	Steam sterilization in office-based, ambulatory-care medical, surgical, and dental facilities
19	1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions
20	2 Definitions and abbreviations
28	3 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
29	3.2.1.2 Decontamination area/room
30	3.2.2 Functional workflow patterns
31	3.2.3 Traffic control
32	Figure 1—Workflow
33	3.3 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
34	3.3.3.3 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
35	3.3.5.2 Walls 3.3.5.3 Ceilings 3.3.5.4 Doors 3.3.5.5 Heating, ventilation, and air conditioning (HVAC) operating parameters
36	3.3.5.6 Lighting Table 1—IES-recommended illuminance levels for work environments 3.3.5.7 Handwashing stations
37	3.3.6 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
38	3.3.6.1.3 Ergonomic considerations 3.3.6.2 Clean work area/room
39	3.3.6.3 Sterilization area 3.3.6.4 Sterile storage
40	3.3.6.5 Breakout area/room 3.3.7 Emergency eyewash/shower equipment
41	4 Personnel considerations 4.1 General considerations 4.2 Qualifications 4.2.1 Supervisory personnel 4.2.2 Sterile processing personnel
42	4.3 Education and training 4.3.1 Sterile processing personnel 4.3.2 Service personnel
43	4.3.3 Other personnel 4.4 Health and personal hygiene 4.5 Attire 4.5.1 General considerations
44	4.5.2 Decontamination area/room
45	4.6 Standard and transmission-based precautions
46	5 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
47	5.2.4 Rigid sterilization container systems
48	5.2.5 Disposable items 5.3 Disposition of sterile items (issued but not used)
49	6 Handling, collection, and transport of contaminated items 6.1 General considerations 6.2 Separation of waste and reusable items at point of use
50	6.3 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
51	6.4 Containment
52	6.5 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
53	6.5.5 Dedicated lifts 6.5.6 Transport between buildings 6.5.7 Off-site transportation
55	7 Cleaning, disinfection (microbicidal processes), and other decontamination steps 7.1 General considerations 7.2 Policies and procedures
56	7.3 Manufacturer’s written IFU 7.4 Decontamination 7.4.1 General considerations for all devices and utensils
57	7.4.2 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
58	7.5.2.2 Rigid sterilization container systems 7.5.2.2.1 General considerations 7.5.2.2.2 Removable filters 7.5.2.2.3 Valves
59	7.5.2.2.4 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
60	7.6.2 Devices with lumens 7.6.3 Cleaning agents 7.6.4 Methods of cleaning 7.6.4.1 Selection of an appropriate method
61	7.6.4.2 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
62	7.6.4.3.3 Selection of mechanical cleaning and disinfection equipment 7.6.4.3.4 Loading mechanical cleaning and disinfection equipment
63	7.6.4.3.5 Unloading mechanical cleaning and disinfection equipment 7.6.4.4 Ultrasonic cleaning equipment 7.6.4.4.1 General considerations
64	7.6.4.4.2 Loading 7.6.4.4.3 Unloading 7.6.4.5 Verification of the cleaning process
66	8 Preparation and assembly of instruments 8.1 General considerations 8.2 Instruments
67	8.3 Devices with lumens 8.4 Basins and basin sets 8.5 Textile packs
68	9 Packaging 9.1 General considerations 9.2 Selection of sterile barrier systems 9.3 Package labeling
69	9.4 Package closures 9.5 Sterilization wrap 9.5.1 General considerations 9.5.2 Woven wraps 9.5.3 Nonwoven wraps
70	9.5.4 Paper–plastic pouches Figure 2—Example of single- and double-packaging with paper–plastic pouches
71	9.6 Wrapping techniques 9.6.1 Simultaneous double-wrapping: envelope fold Figure 3—Simultaneous double-wrapping: envelope fold
72	9.6.2 Simultaneous double-wrapping: square fold Figure 4—Simultaneous double-wrapping: square fold
73	9.6.3 Sequential wrapping: envelope fold Figure 5—Sequential wrapping: envelope fold
74	9.6.4 Sequential wrapping: square fold Figure 6—Sequential wrapping: square fold
75	9.7 Sterility maintenance covers 9.8 Rigid sterilization container systems
77	10 Sterilization 10.1 Loading the sterilizer 10.1.1 General considerations 10.1.2 Paper–plastic pouches 10.1.3 Instrument sets 10.1.4 Textile packs 10.1.5 Utensils and glassware
78	Figure 7—Examples of sterilizer cart loads 10.1.6 Rigid sterilization container systems 10.1.7 Liquids
79	10.1.8 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
80	10.3 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)
81	10.4 Handling and inspection after unloading the sterilizer
82	11 Storage and transportation 11.1 Sterile storage 11.1.1 Storage facilities 11.1.2 Sterility maintenance covers 11.1.3 Shelf life
83	11.2 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
84	11.3.4 Dedicated lifts 11.3.5 Off-site transportation
85	12 Installation, care, and maintenance of sterilizers 12.1 General rationale 12.2 Instruction manuals 12.3 Installation 12.4 Routine care
86	12.5 Preventive maintenance 12.5.1 General considerations 12.5.2 Scheduled maintenance 12.6 Calibration 12.7 Record-keeping
88	13 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
89	13.3.3 Sterilizer records 13.3.4 Record retention 13.4 Sterilization process monitoring
91	Table 2—Sterilization process monitoring recommendations
92	Table 3—Types and applications for use of sterilization monitoring devices
93	13.5 Sterilization process monitoring devices 13.5.1 Physical monitors 13.5.2 Chemical indicators 13.5.2.1 General considerations
95	13.5.2.2 Using chemical indicators 13.5.2.2.1 External chemical indicators 13.5.2.2.2 Internal chemical indicators
96	13.5.3 Biological indicators 13.5.3.1 General considerations 13.5.3.2 Using biological indicators
97	13.5.4 Process challenge devices
98	13.6 Routine load release 13.6.1 Process monitoring devices 13.6.2 Release criteria for nonimplants 13.6.3 Release criteria for implants
99	13.6.4 Sterilization process failure
100	13.7 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
101	Figure 8—Preparation of the 16 towel PCD (BI challenge test pack)
102	Figure 9—Placement 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
103	13.7.3 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
104	13.7.3.4 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
105	13.7.4.4 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
106	13.7.5.2.2 Recall procedure 13.7.5.2.3 Recall report 13.7.5.3 Microbiological testing
107	Figure 10—Decision tree for conducting investigations of steam sterilization processfailures
108	Table 4—Potential causes to be investigated for steam sterilization process failures
110	13.7.6 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
111	Figure 11—Composition 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
112	Figure 12—Placement of the Bowie-Dick test pack
113	13.8 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
114	13.8.2.2 Placement of the PCD 13.8.2.3 BI PCD test procedure 13.8.2.4 Acceptance criteria
115	Figure 13—Placement 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
116	13.8.3.3 Test procedure 13.8.3.4 Acceptance criteria 13.8.4 Qualification testing of IUSS cycles 13.8.4.1 Composition of the PCD
117	13.8.4.2 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
118	13.9.2 Process verification 13.9.3 Product families
119	13.9.4 Verification testing procedure
120	13.10 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
121	13.10.2.2.3 Prepurchase evaluation test protocols Table 5—Summary of test configurations for prepurchaseevaluation of rigid sterilization container systems
122	14 Quality process improvement 14.1 General considerations 14.2 Quality process 14.2.1 General considerations 14.2.2 Quality system model
123	14.2.3 Risk analysis 14.2.3.1 General considerations 14.2.3.2 Design 14.2.3.3 Decontamination
124	14.2.3.4 Personnel 14.2.3.5 Handling of contaminated items 14.2.3.6 Packaging
125	14.2.3.7 Sterilizer loading and unloading 14.2.3.8 Immediate-use steam sterilization 14.2.3.9 Sterility maintenance
126	14.2.3.10 Problem investigation 14.3 Supplier communication 14.4 Repair records 14.5 Processing policies and procedures
127	15 New product evaluation 15.1 General rationale 15.2 Considerations
128	Annex A (informative) Examples of workplace design Figure A.1—Example of a work area design and workflow patternfor a sterile processing area in a typical small hospital
129	Figure A.2—Example of a work area design and workflow pattern for a sterile processing area in a typical medium-sized hospital
130	Figure A.3—Example of a work area design and workflow pattern for a sterile processing area in a typical regional processing center
131	Figure A.4—Example of an ambulatory surgery facility
132	Figure A.5—Example of a dental facility
133	Annex B (informative) Infection transmission and standard precautions B.1 Introduction Figure B.1—The chain of infection, components of the infectious disease process B.2 Chain of infection
134	B.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
135	Figure B.2—Blood-borne pathogen strike-through conversion chart B.2.4 Mode of transmission
136	B.2.5 Portal of entry B.2.6 Susceptible host B.3 Barrier protection and protective clothing
137	Annex C (informative) Processing CJD-contaminated patient care equipment and environmental surfaces C.1 Introduction
140	C.2 Processing devices contaminated with high-risk tissue
141	C.3 Processing devices contaminated with low-risk tissue C.4 Processing devices contaminated with no-risk tissue C.5 Update of recommendations
142	Annex D (informative) User verification of cleaning processes D.1 General considerations
143	D.2 Markers D.3 Cleaning verification tests for users
145	Annex E (informative) Selection and use of chemical disinfectants E.1 Introduction E.2 Categories of items to be disinfected
146	E.3 Activity levels of disinfectants E.4 Labeling of disinfectant products
147	Table E.1—Levels of disinfection according to type of microorganism E.5 Criteria for selecting a chemical disinfectant
148	E.6 Quality control in chemical disinfection
149	E.7 Safety considerations in chemical disinfection
150	Table E.2—Occupational exposure limits for some chemical sterilants and disinfectants
151	Annex F (informative) Thermal disinfection F.1 Introduction F.2 Microbial destruction by heat F.3 Items suitable for thermal disinfection F.4 Manufacturers’ written IFU F.5 Quality control in thermal disinfection F.6 Safety considerations in thermal disinfection
152	Annex G (informative) Devices returned to the manufacturer G.1 Introduction G.2 Overview G.3 Manufacturer’s instructions to the user
153	G.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’s facility G.4.3.1 General considerations G.4.3.2 Postal regulations
154	G.4.3.3 DOT regulations G.5 Receiving at the manufacturer’s facility
155	G.6 Cleaning, decontamination, and sterilization methods at the manufacturer’s facility G.7 Personal protective equipment at the manufacturer’s facility G.8 Work practices for infection prevention and control at the manufacturer’s facility
156	G.9 Housekeeping and waste disposal
157	G.10 Device failure investigation G.11 Documentation to the user
158	Annex H (informative) Development of a prepurchase evaluation protocol for rigid sterilization container systems H.1 Introduction
159	H.2 General considerations H.3 Instruments and devices to be containerized H.4 Cleaning and decontamination considerations
160	H.5 Preparation and assembly considerations H.6 Matching the rigid sterilization container system and sterilization cycle H.7 Loading the sterilizer
161	H.8 Choosing the appropriate exposure and drying times H.9 Unloading the sterilizer and cooling the load H.10 Sterility maintenance
162	H.12 Transportation H.13 Aseptic presentation H.14 Conclusion
163	Annex I (informative) Effect of container systems on load come-up time Figure I.1—Typical rigid sterilization container system processedin a gravity-displacement cycle at 121°C (250°F)
164	Figure I.2—Muslin-wrapped, 16 pound instrument set processed in agravity-displacement cycle at 121°C (250°F) Figure I.3—Typical rigid sterilization container system processed in a prevacuum cycle at 132°C (270°F)
165	Annex J (informative) Development and qualification of the 16 towel PCD (biological-indicator challenge test pack) J.1 Introduction J.2 Survey and preliminary testing
166	Table J.1—16 towel pack survey
167	Figure J.1—Temperature profiles for two different configurations of 12 × 12 × 20 inch packsin a 121°C (250°F) gravity-displacement cycle Figure J.2—Temperature profiles for huck and absorbent 16 towel packs in a 121°C (250°F) gravity-displacement cycle J.3 Validation testing in gravity-displacement cycles
168	Table J.2—Biological-indicator results from 121°C (250°F) gravity-displacement cycle Figure J.3—Average temperature profile for the 16 towel pack in a 121°C (250°F) gravity-displacement cycle J.4 Validation testing in prevacuum cycles
169	Table J.3—Biological-indicator results from 132°C (270°F) deep-vacuum cycle Table J.4—Biological-indicator results from 132°C (270°F) pulsing vacuum cycle J.5 Direct comparison of the 12 ( 12 ( 20 inch and 16 towel test packs
170	Table J.5—Comparison of the 16 towel pack with the12 × 12 × 20 inch pack by Most Probable Number and sterility assessment of spore strips (121°C [250°F] gravity-displacement cycle) Table J.6—Fraction-negative results in a 121°C (250°F) gravity-displacement cycle
171	J.6 Summary of round-robin testing J.7 Supplemental data for steam-flush pressure-pulsing cycles Table J.7—Biological-indicator results from 121°C (250°F)steam-flush pressure-pulse cycle Table J.8—Biological-indicator results from 132°C (270°F)steam-flush pressure-pulse cycle
172	Annex K (informative) Documentation of emergency release of sterilizer loads Figure K.1—Exception form for emergency release of sterilizer load
173	Annex L (informative) Steam quality L.1 Introduction L.2 General considerations L.3 Steam dryness
174	L.4 Noncondensable gases
175	Annex M (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
176	M.2.2.3 Manufacturer’s 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
177	M.3 Resources and training M.4 Summary
178	Annex 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
179	N.4 Types of chemical indicators defined in ANSI/AAMI/ISO 11140-1 vs. the FDA guidance document
181	Table N.1—Comparison of terminology and differences between performance requirements ofANSI/AAMI/ISO 11140-1 and FDA (2003) guidance recommendations
182	Annex O (informative) Moisture assessment
183	Table O.1—Moisture assessment check list
186	Figure O.1—Moisture assessment flow chart
187	Annex P (informative) General considerations for cleaning and disinfection  P.1 Introduction P.2 Mechanical (automated) cleaning and disinfection P.2.1 General considerations
188	P.2.2 Ultrasonic cleaning equipment P.2.2.1 Overview P.2.2.2 Basic ultrasonic washers P.2.2.3 Ultrasonic irrigators   P.2.2.4 Ultrasonic irrigator washers
189	P.2.2.5 Ultrasonic irrigator washer–disinfectors P.2.3 Washer–pasteurizers P.2.4 Washer–disinfectors P.2.4.1 Overview
190	P.2.4.2 Single-chamber washer–disinfectors P.2.4.3 Multi-chamber washer–disinfectors P.2.4.4 Cart washers
191	Annex Q (informative) Alternatives for keeping cool in the sterile processing environment Q.1 Introduction Q.2 Decontamination environment Q.3 Protective attire
192	Q.4 Alternative cooling methods for personnel working in the decontamination area/room
193	Bibliography
203	ANSI/AAMI ST79:2017/A1:2020
204	AAMI Standard Copyright information
205	Contents Page
206	Committee representation
210	Foreword
211	1 Revise content in 3.2.1.1 1.1 General considerations: change header, revise 1st paragraph: Add NOTE and Rationale.
212	Figure 1Example of environmental cleaning checklist
213	2 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
215	ANSI/AAMI ST79:2017/A2:2020
216	AAMI Standard Copyright information
217	Contents Page
218	Committee representation
222	Foreword
223	1 Add new sections 8.2 and 8.2.1 1.1 Change the subsequent numbering of this section; add new related references to Bibliography.
224	Table 1Inspection points and possible damage for various instruments/devices
225	Figure 1Laparoscopic instrumentation: examples of collar not flush against distal working mechanism Figure 2Laparoscopic instrumentation: examples of shaft and handle nicks, cracks, lacerations, gouges, and microscopic pin holes
226	Figure 3Insulated forceps: examples of frays at distal tip, lacerations, housing cracksFigure Figure 4Cables/cords: examples of separation of the cord at the proximal end, nicks, lacerations, pin holes
227	Figure 5LEEP and miscellaneous insulated coated instruments/devices: examples of nicks, lacerations, gouges, pin holes 2 Add to Bibliography
229	ANSI/AAMI ST79:2017/A3:2020
230	AAMI Standard Copyright information
232	Committee representation
236	Foreword
237	1 Revise section 12.4 1.1 Eliminate daily cleaning recommendation.
239	ANSI/AAMI ST79:2017/A4:2020
240	AAMI Standard Copyright information
242	Committee representation
246	Foreword
247	1 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:
248	4 Revise section 13.8.4.3 e) to read:

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Standard Title	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
Published Code	AAMI
Publication Date	2017
Pages Count	248

AAMI ST79 2017 RA2022

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