ANSI/AAMI ST79:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
Hardcopy , PDF
25-01-2021
English
01-01-2017
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Glossary of equivalent standards
Committee representation
Foreword
Introduction: Need for the
recommended practice
1 Scope
2 Definitions and abbreviations
3 Design considerations
4 Personnel considerations
5 Receiving
6 Handling, collection, and transport
of contaminated items
7 Cleaning, disinfection (microbicidal
processes), and other decontamination
steps
8 Preparation and assembly of instruments
9 Packaging
10 Sterilization
11 Storage and transportation
12 Installation, care, and maintenance of
sterilizers
13 Process monitoring, testing, and
quality control
14 Quality process improvement
15 New product evaluation
Annexes
Annex A (informative) - Examples of workplace
design
Annex B (informative) - Infection transmission
and standard precautions
Annex C (informative) - Processing CJD-contaminated
patient care equipment and environmental
surfaces
Annex D (informative) - User verification of cleaning
processes
Annex E (informative) - Selection and use of chemical
disinfectants
Annex F (informative) - Thermal disinfection
Annex G (informative) - Devices returned to the
manufacturer
Annex H (informative) - Development of a prepurchase
Evaluation protocol for rigid sterilization
container systems
Annex I (informative) - Effect of container systems on
load come-up time
Annex J (informative) - Development and qualification
of the 16 towel PCD (biological-indicator
challenge test pack)
Annex K (informative) - Example of documentation of
emergency release of implants
Annex L (informative) - Steam quality
Annex M (informative) - Toxic anterior segment syndrome
(TASS) and the processing of intraocular surgical
instruments
Annex N (informative) - Comparison of the differences
between AAMI and FDA classifications of
chemical indicators
Annex O (informative) - Moisture assessment
Annex P (informative) - General considerations for
cleaning and Disinfection
Annex Q (informative) - Alternatives for keeping cool
in the sterile processing environment
Bibliography
Covers guidance for sterile processing facility design, personnel, receiving, transporting, handling, cleaning, decontamination, preparation, packaging, steam sterilization of reusable medical devices, quality process improvement and new product evaluation.
| DevelopmentNote |
Supersedes AAMI ST33, AAMI ST35, AAMI ST37, AAMI ST42, AAMI ST46, AAMI TIR 10 and AAMI ST1. (08/2006)
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-675-7
|
| Pages |
201
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI TIR55 : 2014 | HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES |
| 17/30351717 DC : 0 | BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| CSA Z314.3 : 2009 : R2014 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
| AAMI/ISO TIR17665-3:2014(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| AAMI ST65:2008(R2018) | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| PD ISO/TS 17665-3:2013 | Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| ASTM F 3293 : 2018 | Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
| ANSI/AAMI ST55:2016 | TABLE-TOP STEAM STERILIZERS |
| AAMI TIR67 : 2018 | PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES |
| UNI CEN ISO/TS 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| ANSI/AAMI ST8:2013(R2018) | HOSPITAL STEAM STERILIZERS |
| AAMI TIR30 : 2011 | A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| CSA Z17665-2:09 (R2019) | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
| ANSI/AAMI ST90:2017 | PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES |
| AAMI TIR34 : 2014 | WATER FOR THE REPROCESSING OF MEDICAL DEVICES |
| AAMI TIR63 : 2014 | MANAGEMENT OF LOANED CRITICAL AND SEMI-CRITICAL MEDICAL DEVICES THAT REQUIRE STERILIZATION OR HIGH-LEVEL DISINFECTION |
| AAMI TIR 11 : 2005 | SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES |
| AAMI TIR31 : 2008 | PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
| CSA Z314.3 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
| CAN/CSA-Z314-18 | Canadian medical device reprocessing |
| AAMI ST65 : 2008 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| AAMI TIR30:2011(R2016) | A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES |
| AAMI TIR17 : 2008 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| AAMI ST15883-1 : 2009 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
| AAMI TIR17 : 2017 | COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION |
| CSA Z314.10.2 : 2015 | LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| CSA Z8000 : 2011 : R2016 | CANADIAN HEALTH CARE FACILITIES |
| CSA Z8000 : 2011 | CANADIAN HEALTH CARE FACILITIES |
| CSA Z8000 : 2011 : INC : UPD 1 : 2013 | CANADIAN HEALTH CARE FACILITIES |
| AAMI ST91 : 2015 | FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES |
| AAMI ISO TIR 17665-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| CSA Z17665-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| AAMI/ISO TIR17665-2:2009(R2016) | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
| CSA Z314.2 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS |
| AAMI TIR11:2005(R2015) | SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES |
| ASHRAE/ASHE 170 : 2017 | VENTILATION OF HEALTH CARE FACILITIES |
| AAMI ST65 : 2008 : R2013 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| DD CEN ISO/TS 17665-2:2009 | Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
| S.R. CEN ISO TS 17665-2:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
| AAMI ISO TIR 17665-3:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
| CSA Z314.0 : 2013 | MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| CEN ISO/TS 17665-2:2009 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |
| AAMI TIR16:2023 | Microbiological aspects of ethylene oxide sterilization |
| AAMI ST35 : 3ED 2003 | SAFE HANDLING AND BIOLOGICAL DECONTAMINATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE FACILITIES AND IN NONCLINICAL SETTINGS |
| CSA Z314.8 : 2014 | DECONTAMINATION OF REUSABLE MEDICAL DEVICES |
| AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
| CFR 21(PTS200-299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
| AAMI TIR34 : 2014 | WATER FOR THE REPROCESSING OF MEDICAL DEVICES |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| CFR 21(PTS170-199) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199 |
| AAMI ISO 18472 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
| AAMI TIR 11 : 2005 | SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES |
| CSA Z314.14 : 2015 | SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS |
| AAMI ISO 15882 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| AAMI ISO TIR 11139 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
| AAMI ST42 : 2ED 98 | STEAM STERILIZATION AND STERILITY ASSURANCE USING TABLE-TOP STERILIZERS IN OFFICE-BASED, AMBULATORY-CARE, MEDICAL, SURGICAL AND DENTAL FACILITIES |
| CFR 49(PTS100-177) : OCT 2017 | TRANSPORTATION |
| ANSI/AAMI ST55:2016 | TABLE-TOP STEAM STERILIZERS |
| ISO 8573-1:2010 | Compressed air Part 1: Contaminants and purity classes |
| ASHRAE HDBK HVAC APPLICATIONS : 2015 | ASHRAE HANDBOOK - HVAC APPLICATIONS |
| ASHRAE/ASHE 170 : 2013 | VENTILATION OF HEALTH CARE FACILITIES |
| AAMI ST65:2008(R2018) | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| AAMI ISO 14161 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
| AAMI RD47 : 2008 | REPROCESSING OF HEMODIALYZERS |
| ASHRAE 62.1 : 2016 | VENTILATION FOR ACCEPTABLE INDOOR AIR QUALITY |
| NFPA 99 : 2018 | HEALTH CARE FACILITIES CODE |
| CFR 29(PT1910.1000 TO END) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| ISO 8996:2004 | Ergonomics of the thermal environment Determination of metabolic rate |
| AAMI IEC 60601-2-16 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT |
| AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
| NFPA 13 : 2016 | INSTALLATION OF SPRINKLER SYSTEMS |
| ANSI Z358.1 : 2014 | EMERGENCY EYEWASH AND SHOWER EQUIPMENT |
| ISA 7.0.01 : 1996 | QUALITY STANDARD FOR INSTRUMENT AIR |
| ASHRAE 55 : 2017 | THERMAL ENVIRONMENTAL CONDITIONS FOR HUMAN OCCUPANCY |
| ANSI/AAMI/ISO 11138-3:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES |
| AAMI ST91 : 2015 | FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES |
| ANSI/AAMI ST8:2013(R2018) | HOSPITAL STEAM STERILIZERS |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| ISO 9920:2007 | Ergonomics of the thermal environment Estimation of thermal insulation and water vapour resistance of a clothing ensemble |
| ANSI/AAMI PB70:2012 | LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES |
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