General Aspects of Medical Devices
Search Results
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AAMI/ISO 10993-15:2019
Biological evaluation of medical devices?Part 15: Identification and quantification of degradation products from metals and alloys
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 10/05/2020.
Languages: English
Historical Editions: AAMI/ISO 10993-15:2000/(R)2011
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AAMI/ISO 14971:2007/(R)2016
This document has been replaced. View the most recent version.
Medical Devices - Application of Risk Management to Medical Devices
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/23/2007.
Languages: English
Historical Editions: AAMI/ISO 14971:2019, AAMI/ISO 14971:2000/A1:2003, AAMI 14971
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AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 05/01/2019.
Languages: English
Historical Editions: AAMI/ISO 14971:2007/(R)2016, AAMI/ISO 14971:2000/A1:2003, AAMI 14971
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AAMI/ISO 15225:2010
This document has been replaced. View the most recent version.
Medical devices - Quality management - Medical device nomenclature data structure
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/20/2010.
Languages: English
Historical Editions: AAMI/ISO 15225:2016, AAMI/ISO 15225:2000 + Amendment 1, AAMI/ISO 15225:2000 (R2006), AAMI/ISO 15225:2000/(R)2006
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AAMI/ISO 15225:2016 [ Withdrawn ]
Medical devices - Quality management - Medical device nomenclature data structure
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/10/2016.
Languages:
Historical Editions: AAMI/ISO 15225:2010, AAMI/ISO 15225:2000 + Amendment 1, AAMI/ISO 15225:2000 (R2006), AAMI/ISO 15225:2000/(R)2006
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AAMI/ISO 16142-1:2016
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/10/2016.
Languages: English
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AAMI/ISO 16142-2:2017
Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/31/2017.
Languages: English
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AAMI/ISO 20417:2021
Medical devices—Information to be supplied by the manufacturer
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 07/18/2024.
Languages: English
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AAMI 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products (ANSI/AAMI/UL 2800-1-1:2022)
standard by Association for the Advancement of Medical Instrumentation, 06/10/2022.
Languages: English
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AAMI 2800-1:2019
This document has been replaced. View the most recent version.
Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
standard by Association for the Advancement of Medical Instrumentation, 02/25/2019.
Languages: English
Historical Editions: AAMI 2800-1:2022