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AAMI TIR31 : 2008

Current

Current

The latest, up-to-date edition.

PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

20-11-2008

€202.79
Excluding VAT

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

17/30363625 DC : DRAFT SEP 2017 BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
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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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