AAMI TIR31 : 2008
Current
The latest, up-to-date edition.
PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
Hardcopy , PDF
English
20-11-2008
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions and abbreviations
4 Historical development of PCDs
5 Selection and use of process challenge devices and test
packs
6 Process challenge devices
6.1 PCDs for steam sterilization
6.1.1 Introduction
6.1.2 Description
6.1.3 Reference BI PCDs - AAMI challenge and routine
BI PCDs
6.1.4 Types of BI PCDs
6.1.5 Recommended practices - Application and frequency
of use
6.2 BI PCDs for ethylene oxide sterilization
6.2.1 Introduction
6.2.2 Description
6.2.3 Reference BI PCDs
6.2.4 Types of BI PCDs
6.2.5 Recommended practices - Application and frequency
of use
6.3 BI PCDs for table-top dry heat sterilization
6.3.1 Introduction
6.3.2 Description
6.3.3 Reference BI PCDs
6.3.4 Types of BI PCDs
6.3.5 Recommended practices - Application and frequency
of use
6.4 BI PCDs for hydrogen peroxide sterilization
6.4.1 Introduction
6.4.2 Description
6.4.3 Reference BI PCDs
6.4.4 Types of BI PCDs
6.4.5 Recommended practices - Application and frequency
of use
6.5 BI PCDs for ozone sterilization process
6.5.1 Introduction
6.5.2 Description
6.5.3 Reference BI PCDs
6.5.4 Types of BI PCDs
6.5.5 Recommended practices - Application and frequency
of use
Annexes
A - Regulatory perspective
B - The Bowie-Dick test pack
C - International perspectives on PCDs
D - Development and qualification of the 16-towel PCD used
for steam sterilization
E - Development and qualification of the routine PCD used
for ethylene oxide sterilization
F - Historical perspective
G - Bibliography
Specifies information that will assist health care facilities in the selection and use of process challenge devices (PCDs).
Committee |
WG 92
|
DocumentType |
Standard
|
ISBN |
1570203253
|
Pages |
46
|
PublisherName |
Association for the Advancement of Medical Instrumentation
|
Status |
Current
|
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CSA Z1416: 2011 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
CSA Z314.3 : 2009 : R2014 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
UNE-EN ISO 14161:2010 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
BS EN ISO 14161:2009 | Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results |
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CSA Z314.3 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
I.S. EN ISO 14161:2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
EN ISO 14161:2009 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
AAMI ST91 : 2015 | FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES |
ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
AAMI ISO 14161 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
DIN EN ISO 14161:2010-03 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
BS EN 867-5:2001 | Non-biological systems for use in sterilizers Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
CSA Z314.2 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS |
AAMI ISO TIR 11139 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
ANSI/AAMI ST55:2016 | TABLE-TOP STEAM STERILIZERS |
BS EN 1422:2014 | Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods |
AAMI TIR 12 : 2010 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS |
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 |
ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
GG-S-1340 Revision A:1975 | STERILIZER, SURGICAL INSTRUMENT AND SUPPLY GRAVITY AIR REMOVAL, NONPORTABLE (HEAT AND MOISTURE STABLE) |
ANSI/AAMI ST8:2013(R2018) | HOSPITAL STEAM STERILIZERS |
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