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AAMI TIR 76 VDmax SD-S Radiation Sterilization Validation Method

  • This latest iteration of the VDmax sterilization validation methodology was published in March of 2021

  • This method expands the VDmax methodology to lower doses and more SAL choices

  • Click below to learn more about this enhancement of the VDmax method

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Sterilization Tutorial

Sterilization process development and validation are built on basic science related to microbiology, chemistry and physics.  The link below is a tutorial that introduces concepts and information that may be helpful to those that are new to sterilization or want to learn more.

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Below is a list of the more commonly used sterilization standards and guidance documents

For a more complete list go to AAMI.org

Microbiological Methods / Environmental Control

  • ANSI/AAMI/ISI 11737-1: 2018 Sterilization of Health Care Products – Microbiology Methods – Part 1: Determination of a Population of Microorganisms on Products

  • 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

  • ANSI/AAMI ST72: 2019 Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing

  • AAMI TIR52: 2014/(R) 2017 Environmental monitoring for terminally sterilized healthcare products


Product/Materials Compatibility

  • AAMI TIR17: 2017/(R)2020 Compatibility of Materials Subject to Sterilization

  • ANSI/AAMI/ISO 10993-7: 2008/(R)2012 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals

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Ethylene Oxide Sterilization

  • ANSI/AAMI/ISO 11135: 2014/A1:2018 Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

  • AAMI TIR28: 2016/(R) 2020 Product adoption and process equivalence for ethylene oxide sterilization

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Radiation Sterilization

  • ANSI/AAMI/ISO 11137-1: 2006/(R)2015 & A1:2013 & A2:2019 Sterilization of Health Care Products-Radiation-Part 1: Requirements for The Development, Validation and Routine Control of a Sterilization Process For Medical Devices

  • ANSI/AAMI/ISO 11137-2: 2013/(R)2019 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

  • ANSI/AAMI/ISO 11137-3: 2017 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control

  • AAMI TIR76: 2021 Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S

  • AAMI TIR35: 2016 Sterilization of health care products—Radiation sterilization— Product adoption and Alternative sampling plans for verification dose experiments and sterilization dose audits

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Moist Heat Sterilization

  • ANSI/AAMI/ISO 17665-1: 2006/(R)2013 Sterilization of health care products—Moist heat—Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices

  • AAMI/ISO TIR17665-2: 2009 Sterilization of health care products—Moist Heat—Part 2: Guidance on the application of AAMI/ISO 17665-1

  • AAMI/ISO TIR17665-3: 2O14/(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


Packaging

  • ANSI/AAMI/ISO 11607-1:2019 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

  • ANSI/AAMI/ISO 11607-2:2019 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

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