ISO10993-11 specifies requirements and gives guidance on procedures to be folllowed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
Systemic toxicity include:
Acute systemic toxicity,
Chronic systemic toxicity.
Subacute systemic toxicity ,
Subchronic systemic toxicity,
Routes of administration include:
Oral, Intravenous, Intraperitoneal, Implantation, Intradermal, Subcutaneous, Intramuscular
Up:Test for irritation
Down:Pyrogenicity test
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