Standard number: GB T 1688611-2021
Standard Name: Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Testing.
Scope of application: This document specifies the requirements for the evaluation of potential adverse systemic reactions caused by medical device materials, and gives guidelines for test procedures. This document applies to systemic toxicity studies of medical devices or materials.
Note: This standard was officially implemented on December 1, 2022.
Technical consultation: 136-1029-1689 Zhang Gong.
Important terms and definitions for systemic toxicity testing.
1.Dose effect: the relationship between dose and the degree of response to a specific biological response in an individual or group of study subjects;
2.Acute systemic toxicity: adverse reactions that occur at any time after one, multiple or continuous exposure to test samples within 24 hours;
3.Subacute systemic toxicity: Adverse reactions that occur after multiple or consecutive exposures to test samples within 24 hours to 28 days. Among them, subacute endovenous studies are usually defined to last from 24 hours to 14 days;
4.Chronic systemic toxicity: Adverse effects that occur during the vast majority of an individual's life after repeated or continuous exposure to test samples. Chronic systemic toxicity studies typically last 6 to 12 months;
5.Subchronic Systemic Toxicity: Adverse effects that occur during the partial life of an individual after repeated or continuous exposure to test samples. Subchronic toxicity studies typically last 90 days in rodents and no more than 10% of their lifespan in other species. Sub-slow intravenous injection studies generally specify a contact time of 14 to 28 days.