AAMI TIR 12 : 2010

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DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS

Publisher: Association for the Advancement of Medical Instrumentation

Published: 09-07-2010

Available Formats: PDF - English - DRM, Hardcopy - English
More Info on product formats

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

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Definitions and abbreviations
3 Design considerations
4 Decontamination
5 Disinfection with liquid chemicals
6 Sterilization
Annexes
A - Liquid chemical disinfectants commonly used in health
    care facilities
B - Sterilization cycles commonly available in health care
    facilities
C - Processing CJD-contaminated patient care equipment and
    environmental surfaces
D - Regulatory considerations
E - Bibliography

Abstract - (Show below) - (Hide below)

Specifies information on decontamination, disinfection and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities.

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

Published
Document Type	Standard
Status	Superseded
Publisher	Association for the Advancement of Medical Instrumentation
Pages
ISBN
Committee	WG 12
Supersedes	AAMI TIR 12 : 2004
Superseded By	AAMI TIR 12:2020

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

AAMI ST65 : 2008 : R2013	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
AAMI TIR31 : 2008	PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
13/30290370 DC : 0	BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES
AAMI ST58 : 2013(R2018)	CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
BS ISO 16840-6 : 2015	WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES OF SEAT CUSHIONS
ASTM D 7225 : 2013-07	GUIDE FOR BLOOD CLEANING EFFICIENCY OF DETERGENTS AND WASHER-DISINFECTORS
13/30280551 DC : 0	BS ISO 16840-6 - WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES - SEAT CUSHIONS
AAMI TIR55 : 2014	HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES
16/30280931 DC : DRAFT APR 2016	BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
AAMI ST40 : 2004	TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI ST55 : 2016	TABLE-TOP STEAM STERILIZERS
AAMI ST40 : 2004 : R2010	TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
ISO 16840-6 : 2015	WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES OF SEAT CUSHIONS
AAMI HE75 : 2009(R2013)	HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
AAMI ST15883-2 : 2013	WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
BS EN ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
AAMI HE75 :2009	HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
AAMI ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
AAMI ST65 : 2008	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
AAMI ST77 : 2013	CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
AAMI ST65 : 2008(R2018)	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
AAMI TIR65 : 2015	SUSTAINABILITY OF MEDICAL DEVICES - ELEMENTS OF A RESPONSIBLE PRODUCT LIFE CYCLE
AAMI TIR30 : 2011	A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
ASTM F 3208 : 2017	Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
AAMI TIR30 : 2011	A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
ISO 17510 : 2015	MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES
CSA Z17510.2 : 2009	SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
AAMI ST41 : 2008	ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
EN ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
AAMI TIR30 : 2011 : R2016	A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
AAMI ST40 : 2004	TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI HE75 : 2009	HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
I.S. EN ISO 17664:2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
ISO 17664 : 2017	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES
DIN EN ISO 17510-2 : 2009	SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
DIN EN ISO 17510-2 E : 2009	SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
BS EN ISO 17510-2 : 2009	SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
ISO 17510-2 : 2007	SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
ANSI/AAMI ST15883-2:2013(R2015)	WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
ANSI/AAMI ST79:2017	COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES

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

AAMI ST40 : 2004	TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI ST41 : 2008	ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
AAMI TIR34 : 2014	WATER FOR THE REPROCESSING OF MEDICAL DEVICES
AAMI ST58 : 2013(R2018)	CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
ASTM E 2314 : 2003	TEST METHOD FOR DETERMINATION OF EFFECTIVENESS OF CLEANING PROCESSES FOR REUSABLE MEDICAL INSTRUMENTS USING A MICROBIOLOGIC METHOD (SIMULATED USE TEST)
AAMI ISO 14937 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI TIR30 : 2011	A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES
ISO 15883-3 : 2006(R2016)	WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
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 ISO 10993-7 : 2008	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
AAMI ISO 11138-2 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
AAMI ISO 10993-1 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
ISO TS 15883-5 : 2005	WASHER-DISINFECTORS - PART 5: TEST SOILS AND METHODS FOR DEMONSTRATING CLEANING EFFICACY
AAMI ST24 : 1999(R2018)	AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
AAMI TIR17 : 2008	COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI ISO 14161 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
ISO 15883-4 : 2008(R2011)	WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
CFR 29(PT1910.1000 TO END) : 0	LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
AAMI ISO 11135-1 : 2007	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ISO 17665-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ST81 : 2004	STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
ANSI/AAMI ST79:2017	COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI TIR13 : 1ED 97	PRINCIPLES OF INDUSTRIAL MOIST HEAT STERILIZATION
AAMI ISO 11138-3 : 2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES
ASTM D 7225 : 2013-07	GUIDE FOR BLOOD CLEANING EFFICIENCY OF DETERGENTS AND WASHER-DISINFECTORS
AAMI ST8 : 2013(R2018)	HOSPITAL STEAM STERILIZERS
AAMI ST77 : 2013	CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
AAMI PB70 : 2012	LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES
AAMI ST63 : 2002	STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT
AAMI ST15883-1 : 2009	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS

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AAMI TIR 12 : 2010

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