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13408 Series Special Seven-Document Set (PDF)

Includes the current edition of all seven ANSI/AAMI/ISO 13408 documents dealing with Aseptic processing of health care products, PDF Format
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AAMI TIR14:2016

Contract sterilization using ethylene oxide
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AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
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AAMI TIR16:2017 (PDF)

Microbiological aspects of ethylene oxide sterilization
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AAMI TIR17:2017 (PDF)

Compatibility of materials subject to sterilization
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TIR19 & A1 Combined

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
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AAMI TIR29:2012/(R)2017 (PDF)

Guide for process characterization and control in radiation sterilization of medical devices
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AAMI TIR35:2016

Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits
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AAMI TIR37:2013

Sterilization of health care products—Radiation—Guidance on sterilization of biologics and tissue-based products
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AAMI TIR40:2018 (PDF)

Sterilization of health care products—Radiation—Guidance on dose setting utilizing a Modified Method 2
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AAMI TIR52:2014/(R)2017 (PDF)

Environmental monitoring for terminally sterilized healthcare products
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AAMI TIR56:2013/(R)2016 (PDF)


Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
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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
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AAMI/IEC TIR62366-2:2016

Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.
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AAMI/ISO TIR13004:2013/(R)2016

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD
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AAMI/ISO TIR17665-2:2009/(R)2016 (PDF)

Sterilization of health care products - Moist Heat - Part 2: Guidance on the application of AAMI/ISO 17665-1
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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
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ANSI/AAMI ST67:2011/(R)2017 (PDF)

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ´sterile’
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ANSI/AAMI/ ISO 11137-1: 2006/(R)2015 & A1:2013 (PDF)

Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices (Consolidated Text)
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