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ISO - 10993-18 AMD 1

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process AMENDMENT 1: Determination of the uncertainty factor

active, Most Current
Organization: ISO
Publication Date: 1 May 2022
Status: active
Page Count: 10
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

10993-18 AMD 1
May 1, 2022
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process AMENDMENT 1: Determination of the uncertainty factor
A description is not available for this item.
January 1, 2020
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation...
July 1, 2005
Biological evaluation of medical devices Part 18: Chemical characterization of materials
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information...
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