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  3. AAMI/ISO 10993-1:2018 PDF

AAMI/ISO 10993-1:2018 PDF

AAMI/ISO 10993-1:2018 PDF

Name:
AAMI/ISO 10993-1:2018 PDF

Published Date:
04/27/2020

Status:
Active

Description:

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

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
SKU:
Choose Document Language:
$82.5
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This document specifies:
  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of medical 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 analyse the biological safety of the medical device;
  • the assessment of the biological safety of the medical device.

ANSI : ANSI Approved
File Size : 1 file , 840 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 53
Published : 04/27/2020

History

AAMI/ISO 10993-1:2018
AAMI/ISO 10993-1:2018
Published Date: 04/27/2020
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
$82.5
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
AAMI/ISO 10993-1:2003
Published Date: 12/01/2003
Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
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