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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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AAMI/ISO TIR21900:2018 (PDF)

Guidance for uncertainty analysis regarding the application of ISO/TS 10974
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AAMI/ISO TIR24971:2013/(R)2016

Medical devices - Guidance on the application of ISO 14971.
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AAMI's Career Planning Handbook

A Resource for Healthcare Technology Management Professionals
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AAMI's Leadership Development Guide (PDF)

A Resource for Healthcare Technology Management Professionals
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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 ST79:2017

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
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ANSI/AAMI/ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
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ANSI/AAMI/ISO 10993-15:2000/(R)2011

Biological evaluation of medical devices, Part 15: Identification and quantification of degradation products from metals and alloys.
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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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ANSI/AAMI/ISO 11137-3-2017 (PDF)

Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control
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ANSI/AAMI/ISO 13408-1:2008/(R)2017 & A1:2013

Aseptic processing of health care products -- Part 1: General requirements (includes Amendment 1).
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ANSI/AAMI/ISO 13408-2:2018 (PDF)

Aseptic processing of health care products—Part 2: Sterilizing filtration
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ANSI/AAMI/ISO 13408-3:2006/(R)2015

Aseptic processing of health care products - Part 3: Lyophilization.
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ANSI/AAMI/ISO 13408-4-2005/(R)2014

Aseptic processing of health care products - Part 4: Clean-in-place technologies
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ANSI/AAMI/ISO 13408-5-2006/(R)2015

Aseptic processing of health care products - Part 5: Sterilization in place
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ANSI/AAMI/ISO 13408-6:2005/(R)2013

Aseptic processing of health care products -- Part 6: Isolator systems. (Includes Amendment 1)
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ANSI/AAMI/ISO 13408-7:2012/(R)2018 (PDF)

Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products
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ANSI/AAMI/ISO 14161:2009/(R)2014

Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results.
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ANSI/AAMI/ISO 14161:2009/(R)2014 Redline (PDF)

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