ANSI/AAMI ST79:2017

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s): Hardcopy, PDF

Superseded date: 25-01-2021

Language(s): English

Published date: 01-01-2017

Publisher: Association for the Advancement of Medical Instrumentation

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

General Product Information - (Show below) - (Hide below)

Development Note	Supersedes AAMI ST33, AAMI ST35, AAMI ST37, AAMI ST42, AAMI ST46, AAMI TIR 10 and AAMI ST1. (08/2006)
Document Type	Standard
ISBN
Pages
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	ANSI/AAMI ST79:2017 with Amendments A1:2020, A2:2020, A3:2020, A4:2020
Supersedes	AAMI ST1 : LATEST ANSI/AAMI ST37:3ED 1996 AAMI ST46 : 4ED 2002 AAMI ST79 : 2010 : R2014 AAMI TIR 10 : 1993 AAMI ST33 : 2ED 96

Standards Referenced By This Book - (Show below) - (Hide below)

PLUS 1173 (1st ed. pub. 2012)	Guide to the selection and use of sterilization indicators
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
CSA Z17665-2:09 (R2019)	Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
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

Standards Referencing This Book - (Show below) - (Hide below)

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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