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AAMI TIR14:2016
Contract sterilization using ethylene oxide
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$72.00
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$127.00
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$127.00
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AAMI TIR15:2016 (PDF)
Physical aspects of ethylene oxide sterilization
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$90.00
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$157.00
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AAMI TIR16:2017 (PDF)
Microbiological aspects of ethylene oxide sterilization
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$90.00
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$157.00
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AAMI TIR17:2017 (PDF)
Compatibility of materials subject to sterilization
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$151.00
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$251.00
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AAMI TIR28:2016 (PDF)
Product adoption and process equivalence for ethylene oxide sterilization
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$72.00
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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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$126.00
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$221.00
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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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$111.00
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$194.00
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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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$72.00
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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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$90.00
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$157.00
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AAMI TIR52:2014/(R)2017 (PDF)
Environmental monitoring for terminally sterilized healthcare products
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$63.00
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$111.00
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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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$90.00
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$157.00
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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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$72.00
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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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$133.00
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$236.00
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$236.00
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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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$133.00
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$236.00
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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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$133.00
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$236.00
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ANSI/AAMI ST67:2019
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
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$72.00
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ANSI/AAMI ST72:2019
Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
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$133.00
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ANSI/AAMI/ ISO 11137-2: 2013/(R)2019
Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
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$133.00
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ANSI/AAMI/ISO 10993-7:2008/(R)2012
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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$133.00
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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.
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$155.00
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$274.00
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