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  • AAMI ISO TIR 17665-2 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-09-2021

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO TIR17665-2:2009
    AAMI inclusion to ISO TIR17665-2:2009
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system elements
    5 Sterilizing agent characterization
    6 Process and equipment characterization
    7 Product definition
    8 Process definition
    9 Validation
    10 Routine monitoring and control
    11 Product release from sterilization
    12 Maintaining process effectiveness
    Annex A (informative) - Evaluation of a sterilization
                            process primarily based on the
                            measurement of physical parameters
    Annex B (informative) - Evaluation of a sterilization
                            process primarily based on
                            biological inactivation and an
                            accompanying mechanical air
                            removal procedure
    Annex C (informative) - Temperature and pressure of
                            saturated steam for use in
                            moist heat sterilization
    Annex D (informative) - Special considerations for health
                            care settings
    Annex E (informative) - Index of normative clauses/subclauses
                            of ISO 17665-1 and cited references
                            or related guidance given in ISO
                            17665-1 and ISO/TS 17665-2
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1.

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

    Development Note Supersedes AAMI TIR13. Together with AAMI ISO 17665-1, it supersedes AAMI ISO 11134. (07/2009)
    Document Type Standard
    Product Note Reconfirmed 2009
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
    ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
    BS EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
    EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
    BS EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
    EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
    EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
    ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    BS EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
    ISO 14040:2006 Environmental management Life cycle assessment Principles and framework
    ISO 15883-2:2006 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    EN 13060:2014 Small steam sterilizers
    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
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