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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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$230.00
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$488.00
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AAMI TIR14:2016

Contract sterilization using ethylene oxide
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$67.00
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$119.00
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AAMI TIR15:2016 (PDF)

Physical aspects of ethylene oxide sterilization
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$84.00
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$148.00
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AAMI TIR16:2009/(R) 2013

Microbiological aspects of ethylene oxide sterilization.
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$84.00
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$148.00
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AAMI TIR17:2008

Compatibility of Materials Subject to Sterilization
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$146.00
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$243.00
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AAMI TIR19/A1:1999

Amendment 1 to AAMI TIR19:1998, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. (Superseded; historical/reference only) Free with purchases of TIR19.
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$36.00
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$64.00
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AAMI TIR19:1998

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$59.00
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$104.00
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AAMI TIR19:1998 and A1:1999 (PDF Format)

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$59.00
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$104.00
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AAMI TIR28:2016 (PDF)

Product adoption and process equivalence for ethylene oxide sterilization
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$67.00
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$119.00
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AAMI TIR29:2012

Guide for process characterization and control in radiation sterilization of medical devices
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$118.00
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$208.00
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AAMI TIR33:2005

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
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$125.00
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$222.00
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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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$104.00
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$183.00
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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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$67.00
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$119.00
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AAMI TIR40:2009/(R)2016

Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2.
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$84.00
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$148.00
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AAMI TIR52:2014

Environmental monitoring for terminally sterilized healthcare products.
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$59.00
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$104.00
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AAMI TIR56:2013/(R)2016 (PDF)

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$104.00
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$183.00
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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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$67.00
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$119.00
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AAMI/CDV-2 (ISO/DIS) 13408-06:2005/A1 (PDF Format)

Aseptic processing of health care products - Part 6: Isolator systems, Amendment 1, PDF format.
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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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$146.00
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$258.00
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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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$125.00
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$222.00
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