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AAMI ANSI/AAMI/ISO 10993-1:2018

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
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AAMI ANSI/AAMI/ISO 10993-1:2018

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

PUBLISH DATE 2018
AAMI ANSI/AAMI/ISO 10993-1:2018
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 10993-1
Publication Date Jan. 1, 2018
Language en - English
Page Count 53
Revision Level
Supercedes
Committee
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