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  • ANSI/AAMI ISO 17665-1:2006(R2013)

    Current The latest, up-to-date edition.

    STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  02-12-2013

    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 17665-1:2006
    Foreword
    Introduction
    1 Scope
       1.1 Inclusions
       1.2 Exclusions
    2 Normative references
    3 Terms and definitions
    4 Quality management system elements
       4.1 Documentation
       4.2 Management responsibility
       4.3 Product realization
       4.4 Measurement, analysis and improvement - Control
            of non-conforming product
    5 Sterilizing agent characterization
       5.1 Sterilizing agent
       5.2 Microbicidal effectiveness
       5.3 Materials effects
       5.4 Environmental consideration
    6 Process and equipment characterization
       6.1 Process
            6.1.1 General
            6.1.2 Saturated steam process
            6.1.3 Contained product processes
       6.2 Equipment
    7 Product definition
    8 Process definition
    9 Validation
       9.1 General
       9.2 Installation qualification (IQ)
            9.2.1 Equipment
            9.2.2 Installation
            9.2.3 Function
       9.3 Operational qualification (OQ)
       9.4 Performance qualification (PQ)
       9.5 Review and approval of validation
    10 Routine monitoring and control
    11 Product release from sterilization
    12 Maintaining process effectiveness
       12.1 Demonstration of continued effectiveness
       12.2 Recalibration
       12.3 Maintenance of equipment
       12.4 Requalification
    Annex A (informative) - Guidance
    Annex B (informative) - Process definition based on
                            inactivation of the microbial
                            population in its natural state
                            (bioburden-based method)
    Annex C (informative) - Process definition based on the
                            inactivation of a reference
                            microorganism and a knowledge of
                            bioburden on product items to be
                            sterilized (combined bioburden/biological
                            indicator based method
    Annex D (informative) - Conservative process definition
                            based on inactivation of reference
                            microorganisms (overkill method)
    Annex E (informative) - Operating cycles
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

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

    Committee WG 03
    Development Note Supersedes AAMI ISO 11134 (05/2006)
    Document Type Standard
    Product Note Reconfirmed 2013
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    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
    EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    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
    EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    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
    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
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    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 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
    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 9004:2009 Managing for the sustained success of an organization A quality management approach
    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 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9001:2015 Quality management systems — Requirements
    ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    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
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
    ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
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