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AAMI/ISO 13485:2016, A Practical Guide

Medical Devices—A Practical Guide, Advice from ISO/TC 210
$96.00
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$134.00
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AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
$160.00
$282.00
$282.00
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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
$137.00
$243.00
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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
$137.00
$243.00
$243.00

AAMI/ISO TIR21900:2018 (PDF)

Guidance for uncertainty analysis regarding the application of ISO/TS 10974
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AAMI/ISO TIR24971:2020

Medical devices—Guidance on the application of ISO 14971
$160.00
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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 ST67:2019

Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
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$131.00
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ANSI/AAMI ST79:2017

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
$357.00
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ANSI/AAMI/ISO 10993-11:2017

Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
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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.
$74.00
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ANSI/AAMI/ISO 10993-7:2008/(R)2012

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
$137.00
$243.00
$243.00

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
$74.00
$131.00
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ANSI/AAMI/ISO 11138-7:2019

Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use and interpretation of results
$137.00
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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).
$137.00
$243.00
$243.00

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.
$74.00
$131.00
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ANSI/AAMI/ISO 13408-4-2005/(R)2014

Aseptic processing of health care products - Part 4: Clean-in-place technologies
$74.00
$131.00
$131.00
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