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  • AAMI
    AAMI Sterilization Package
    Edition: VAR
    $5,099.40
    / user per year

Content Description

AAMI Sterilization Package package includes:
  • ANSI/AAMI/ISO 11135:2014 - Sterilization of health care products-Ethylene oxide-Requirements for development, validation and routine control of a sterilization process for medical devices / 2014
  • ANSI/AAMI/ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 - Sterilization of health care products-Radiation-Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices / 2006
  • ANSI/AAMI/ ISO 11137-2: 2013/(R)2019 - Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose / 2017
  • ANSI/AAMI/ISO 11137-3-2017 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control / 2017
  • ANSI/AAMI/ISO 11138-1:2017 - Sterilization of health care products-Biological indicators-Part 1: General requirements / 2017
  • ANSI/AAMI/ISO 11138-2:2017 - Sterilization of health care products-Biological indicators-Part 2: Biological indicators for ethylene oxide sterilization processes / 2017
  • ANSI/AAMI/ISO 11138-3:2017 - Sterilization of health care products-Biological indicators-Part 3: Biological indicators for moist heat sterilization processes / 2017
  • ANSI/AAMI/ISO 11138-4:2017 - Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes / 2017
  • ANSI/AAMI/ISO 11138-5:2017 - Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes / 2017
  • ANSI/AAMI/ISO 11138-7:2019 - Sterilization of health care products-Biological indicators-Part 7: Guidance for the selection, use and interpretation of results / 2019
  • ANSI/AAMI/ISO 11140-1:2014 - Sterilization of health care products - Chemical indicators - Part 1: General requirements / 2014
  • ANSI/AAMI/ISO 11140-3:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test / 2007
  • ANSI/AAMI/ISO 11140-4:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration / 2007
  • ANSI/AAMI/ISO 11140-5:2007/(R)2015 - Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs. / 2007
  • ANSI/AAMI/ISO 11607-1:2019 - Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems / 2019
  • ANSI/AAMI/ISO 11607-2:2019 - Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes / 2019
  • ANSI/AAMI/ISO 11737-1:2018 - Sterilization of health care products-Microbiological methods-Part 1: Determination of a population of microorganisms on products / 2018
  • ANSI/AAMI/ISO 11737-2:2019 - Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process / 2019
  • ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013 - Aseptic processing of health care products- Part 1: General requirements (includes Amendment 1). / 2008
  • ANSI/AAMI/ISO 13408-2:2018 - Aseptic processing of health care products-Part 2: Sterilizing filtration / 2018
  • ANSI/AAMI/ISO 13408-3:2006/(R)2015 - Aseptic processing of health care products-Part 3: Lyophilization / 2006
  • ANSI/AAMI/ISO 13408-4-2005/(R)2014 - Aseptic processing of health care products-Part 4: Clean-in-place technologies / 2005
  • ANSI/AAMI/ISO 13408-5-2006/(R)2015 - Aseptic processing of health care products-Part 5: Sterilization in place / 2006
  • ANSI/AAMI/ISO 13408-6:2005/(R)2013 & A1:2013 - Aseptic processing of health care products - Part 6: Isolator systems / 2005
  • ANSI/AAMI/ISO 13408-7:2012/(R)2018 - Aseptic processing of health care products-Part 7: Alternative processes for medical devices and combination products / 2012
  • ANSI/AAMI/ISO 14160:2011/(R)2016 - Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation and routine control of a sterilization process for medical devices / 2011
  • ANSI/AAMI/ISO 14937:2009/(R) 2013 - 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 / 2009
  • ANSI/AAMI/ISO 15882:2008/(R)2013 - Sterilization of health care products - Chemical indicators-Guidance for selection, use and interpretation of results. / 2008
  • ANSI/AAMI/ISO 17664:2017 - Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices / 2017
  • ANSI/AAMI/ISO 17665-1:2006/(R)2013 - Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization / 2006
  • ANSI/AAMI/ISO 20857:2010/(R)2015 - Sterilization of health care products-Dry heat: Requirements for the development, validation and routine control of a sterilization process for medical devices / 2010
  • ANSI/AAMI PB70:2012 - Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities / 2012
  • ANSI/AAMI/ST8:2013/(R)2018 - Hospital steam sterilizers / 2013
  • ANSI/AAMI ST24:1999/(R)2018 - Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities / 1999
  • ANSI/AAMI ST40:2004/(R)2018 - Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities / 2004
  • ANSI/AAMI ST41:2008/(R)2018 - Ethylene oxide sterilization in health care facilities: Safety and effectiveness / 2008
  • ANSI/AAMI ST50:2004/(R)2018 - Dry heat (heated air) sterilizers / 2004
  • ANSI/AAMI ST55:2016 - Table-top Steam Sterilizers / 2016
  • ANSI/AAMI ST58:2013/(R)2018 - Chemical sterilization and high-level disinfection in health care facilities / 2013
  • ANSI/AAMI ST65:2008/(R)2018 - Processing of reusable surgical textiles for use in health care facilities / 2008
  • ANSI/AAMI ST67:2019 - Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” / 2019
  • ANSI/AAMI ST72:2019, Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing / 2019
  • ANSI/AAMI ST77:2013/(R)2018 - Containment devices for reusable medical device sterilization / 2013
  • ANSI/AAMI ST79:2017 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities / 2017
  • ANSI/AAMI ST90:2017 - Processing of health care products - Quality management systems for processing in health care facilities / 2017
  • ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities / 2021
  • ANSI/AAMI ST15883-1:2009/(R)2014 &A1:2014&A2:2012 - (Consolidated Text) (ISO 15883-1:2006, MOD) Washer-disinfectors-Part 1: General requirements, terms and definitions and tests / 2009
  • ANSI/AAMI ST15883-2:2013/(R)2015 (ISO 15883-2:2006 MOD) - Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. / 2013
  • ANSI/AAMI ST15883-3:2012/(R)2015 - Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers / 2012
  • AAMI TIR11:2005/(R)2015 - Selection and use of protective apparel and surgical drapes in health care facilities / 2005
  • AAMI TIR12:2020, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers / 2020
  • AAMI TIR14:2016 - Contract sterilization using ethylene oxide / 2016
  • AAMI TIR15:2016 - Physical aspects of ethylene oxide sterilization / 2016
  • AAMI TIR16:2017 - Microbiological aspects of ethylene oxide sterilization / 2017
  • AAMI TIR17:2017 - Compatibility of materials subject to sterilization / 2017
  • AAMI TIR28:2016 - Product adoption and process equivalence for ethylene oxide sterilization / 2016
  • AAMI TIR29:2012/(R)2017 - Guide for process characterization and control in radiation sterilization of medical devices / 2012
  • AAMI TIR30:2011/(R)2016 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices / 2011
  • AAMI TIR31:2008 - Process challenge devices/test packs for use in health care facilities / 2008
  • AAMI TIR34: 2014/(R)2017 - Water for the reprocessing of medical devices / 2014
  • AAMI TIR35:2016 - Sterilization of health care products-Radiation sterilization-Alternative sampling plans for verification dose experiments and sterilization dose audits / 2016
  • AAMI TIR37:2013 - Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products / 2013
  • AAMI TIR39:2009/(R)2017 - Technical Information Report Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices / 2009
  • AAMI TIR40:2018 - Sterilization of health care products-Radiation-Guidance on dose setting utilizing a Modified Method 2 / 2018
  • AAMI TIR52:2014/(R)2017 - Environmental monitoring for terminally sterilized healthcare products / 2014
  • AAMI TIR55:2014/(R)2017 - Human factors engineering for processing medical devices / 2014
  • AAMI TIR63: 2014/(R)2017 - Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection / 2014
  • AAMI TIR67:2018 - Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities / 2018
  • AAMI TIR68:2018 - Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces / 2018
  • AAMI TIR74: 2016 - Change summary for ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices / 2016
  • AAMI/ISO TIR13004:2013/(R)2016 - Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose: Method VDmaxSD / 2013
  • AAMI/ISO TIR16775:2014 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 / 2014
  • ANSI/AAMI/ISO TIR17665-2:2009/(R)2016 - Technical Information Report Sterilization of health care products – Moist Heat – Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 / 2009
  • AAMI/ISO TIR17665-3:2014/(R)2016 - Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization / 2014
  • ANSI/AAMI/ISO TIR19024:2016 - Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass / 2016

About AAMI

The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 8,000 professionals united by one important mission—the development, management, and use of safe and effective health technology.
 
AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals. AAMI helps members:
 
Contain costs
Stay on top of new technology and policy developments
Add value in healthcare organizations
Improve professional skills
Enhance patient care
AAMI provides a unique and critical forum for a variety of professionals including clinical and biomedical engineers and technicians, physicians, nurses, hospital administrators, educators, scientists, manufacturers, distributors, government regulators, and others with an interest in healthcare technology. AAMI fulfills its mission through:
 
Courses, conferences, and continuing education, including certification programs.
Collaborative initiatives, including summits with the FDA
A rich array of resources, including peer-reviewed journals, technical documents, books, videos, podcasts, and other products.
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