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  3. AAMI/ISO 10993-1:2009/(R)2013 PDF

AAMI/ISO 10993-1:2009/(R)2013 PDF

AAMI/ISO 10993-1:2009/(R)2013 PDF

Name:
AAMI/ISO 10993-1:2009/(R)2013 PDF

Published Date:
09/03/2009

Status:
[ Withdrawn ]

Description:

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

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
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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.
ANSI : ANSI Approved
ISBN(s) : 1570203709
Number of Pages : 38
Published : 09/03/2009
Same As : AAMI/ISO 10993-1:2009/(R)2013

History

AAMI/ISO 10993-1:2018
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AAMI/ISO 10993-1:2009/(R)2013
AAMI/ISO 10993-1:2009/(R)2013
Published Date: 09/03/2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Includes Erratum (2013)
AAMI/ISO 10993-1:2003
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