AAMI ANSI/AAMI/ISO 10993-1:2018

Current Revision

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

Name: AAMI ANSI/AAMI/ISO 10993-1:2018 – Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
Brand: Assoc. for the Advancement of Medical Instrumentation
SKU: AAMI ANSI/AAMI/ISO 10993-1:2018
Price: 285.00 USD
Availability: InStock

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

PUBLISH DATE 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.