AAMI/ISO TIR10993-20:2006/(R)2021

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AAMI/ISO TIR10993-20:2006/(R)2021

2006

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Biological evaluation of medical devices – Part 20: Principles and methods for immunotoxicology testing fo medical devices

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This part of ISO 10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices.

This part of ISO 10993 is based on several publications written by various groups of immunotoxicologists over the last few decades in which the development of immunotoxicology as a separate entity within toxicology took place.

The current state of knowledge with regard to immunotoxicity is described in Annex A. A summary of clinical experience to date with immunotoxicology associated with medical devices is given in Annex B.

AAMI/ISO TIR10993-20:2006/(R)2021
STANDARD INFO:
Standard NameAAMI/ISO TIR10993-20:2006/(R)2021
ScopeBiological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing fo medical devices
PublisherAAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization
LanguagesEnglish
State
Publication Year2006
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
File Size1 file , 790 KB
NoteThis product is unavailable in Ukraine, Russia, Belarus
Number of Pages32
Published08/01/2006
AAMI/ISO TIR10993-20:2006/(R)2021
HistoryPublisher Year

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