• AAMI TIR31 : 2008

    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

    Publisher:  Association for the Advancement of Medical Instrumentation

    Add To Cart

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

    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

    Abstract - (Show below) - (Hide below)

    Specifies information that will assist health care facilities in the selection and use of process challenge devices (PCDs).

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

    Committee WG 92
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

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

    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
    08/30149503 DC : DRAFT JAN 2008 BS EN ISO 14161 - STERILIZATION OF HEALTH CAR PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    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
    AAMI TIR67 : 2018 PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES
    CSA Z14161 : 2011 : R2015 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
    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

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

    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
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective