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  1. Home
  2. AAMI/ISO 10993-1:2009/(R)2013

AAMI/ISO 10993-1:2009/(R)2013 Historical [ Withdrawn ]

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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Includes Erratum (2013)

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 09/03/2009

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Identical Versions Available

  • ISO 10993-1:2009

    October 2009
    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    • Historical Version

Full Description

ISO 10993-1 describes the general principles governing the biological evaluation of medical devices within a risk management framework; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyze the biological safety of the medical device; and the assessment of the biological safety of the medical device.
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Document History

  1. AAMI/ISO 10993-1:2018

    April 2020
    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    • Most Recent  Most Recent
  2. AAMI/ISO 10993-1:2009/(R)2013

    You are currently viewing this product 👀 currently
    viewing

    September 2009
    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Includes Erratum (2013)

    • Historical Version
  3. AAMI/ISO 10993-1:2003

    December 2003
    Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. AAMI/ISO 10993-1:2009 Erratum

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    June 2013
    Erratum for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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  • Association for the Advancement of Medical Instrumentation > Biological Evaluation

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Product Details

Published:

09/03/2009

ISBN(s):

1570203709

ANSI:

ANSI Approved

Number of Pages:

38

Same As:

ISO 10993-1:2009

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