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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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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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ANSI/AAMI/ISO 22442-3:2007/(R)2016

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transimissible spongiform encephalopathy (TSE) agents
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