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AAMI/ISO TIR15499:2017 (PDF)

Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
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AAMI/ISO TIR22442-4:2011/(R)2016

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes.
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An Overview of ANSI/AAMI/ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects

Clinical studies are included in almost all new devices presented for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) and may also apply to the approximately 10% of devices under premarket notification that contain clinical data. ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects addresses the practical aspects of how to plan clinical investigations conducted in human subjects and defines procedures for the design, conduct, recording, and reporting of a clinical study. The latest version of the standard has been updated to provide step-by-step guidance on the creation and execution of a clinical study. This webinar will address good clinical practice in clinical investigations of medical devices for human subjects using ISO 14155 as a guide.
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ANSI/AAMI BE83:2006/(R)2011

Biological evaluation of medical devices - Part 18: Chemical characterization of materials.
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ANSI/AAMI/ISO 10993-1:2009/(R)2013 (PDF)


For previous purchases: To view the errata sheet for this file click here. (For new purchases: Errata now included in original publication.)
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ANSI/AAMI/ISO 10993-10:2010/(R)2014

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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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 10993-13-2010/(R)2014

Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices.
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ANSI/AAMI/ISO 10993-14:2001/(R)2011

Biological evaluation of medical devices, Part 14: Identification and quantification of degradation products from ceramics.
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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 10993-17:2002/(R)2012

Biological evaluation of medical devices, Part 17: Establishment of allowable limits for leachable substances.
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ANSI/AAMI/ISO 10993-2-2006/(R)2014

Biological evaluation of medical devices - Part 2: Animal welfare requirements
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ANSI/AAMI/ISO 10993-3:2014

Biological evaluation of medical devices-Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
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ANSI/AAMI/ISO 10993-5:2009/(R)2014

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
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ANSI/AAMI/ISO 10993-6:2016 (PDF)

Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
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ANSI/AAMI/ISO 10993-9:2009/(R)2014

Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products.
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ANSI/AAMI/ISO 13022:2012

Medical products containing viable human cells -- Application of risk management and requirements for processing practices.
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ANSI/AAMI/ISO 14155:2011

Clinical investigation of medical devices for human subjects.
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ANSI/AAMI/ISO 22442-1:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management.
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ANSI/AAMI/ISO 22442-2:2016 (PDF)

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling.
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