General Toxicity Study
The general toxicity study should be conducted to long-term/permanent contact or exposure, circulating blood system, and injured surface-contacting medical devices. Its purpose is to evaluate the potential toxicity in an organism, and this test provides important references for long-term application safety.
General toxicity study for medical device including
- Acute Systemic Toxicity Study
- Sub-acute/Subchronic Toxicity study
- Chronic/Carcinogenicity Toxicity Study
- Reproduction/Developmental Toxicity Study
Introduction for General Toxicity Study
Acute Systemic Toxicity
The study evaluates whether organisms have acute toxicity when medical devices are exposed to systemic circulation. According to ISO guidelines, mice are the test animals (please contact us for other species). The extract of the test article is administered by intravenous injection, tail vein, or intraperitoneal injection. The symptoms of acute toxicity are observed continuously for 14 days. The results are used to evaluate the acute toxicity reaction and provide the dosing reference for other toxicity studies.
References:
ISO 10993-11 : Tests for systemic toxicity
GB/T 16886.10
Sub-acute/Subchronic Toxicity Study
The study evaluates the toxicity effects generated by medical devices on organisms with long-term exposure. According to ISO guidelines, a rat is the test animal (please contact us for other species). The extract of the test article is administered orally for 28 or 90 days continuously (please contact us for other methods). Observation includes clinical observation, hematological examination, clinical biochemistry, urine examination, organ examination, and histopathological examination. The results are used to evaluate the exposure safety on humans and provide an important reference long-term application safety.
References:
ISO 10993-11 : Tests for systemic toxicity
GB/T 16886.10
Reproduction/Developmental Toxicity
The reproduction/developmental toxicity test for medical devices is a supplementary evaluation test. Reproduction/developmental toxicity involves the effects for medical device contacting to development of germ cells, embryogenesis, pregnancy, parturition, breastfeeding, and development of fetal rats. The rat is the test animal in the reproduction/developmental toxicity test, and the extract of test article is dosing by oral administration (please contact us for other species or methods).
According to ISO guidelines, examination in a one-generation reproduction toxicity test includes development of germ cells, fertility analysis for males and females, breeding behavior analysis, and examination of fetal rats.
The two-generation reproduction toxicity test starts with the rat embryo and continues through the infant’s growth period with medical device contacting continuously. It involves the examination of the one-generation reproduction toxicity test and fertility analysis for progeny to evaluate the reproduction/developmental toxicity of the test article. Since reproduction is a sensitive stage for exposure to external substances, the effects would become more extensive and comprehensive. The results are used to evaluate the effects of the test article on reproduction and the expected effects on fertility and embryo development after exposure in humans. The study provides an important safety reference.
References:
ISO 10993-3 : Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3
Chronic/Carcinogenicity Toxicity
The carcinogenicity toxicity test for medical devices is a supplementary evaluation test. The purpose is to observe the type, form, and quantity of induced tumors on the test animal caused by a medical device’s contact throughout most of the life cycle. According to ISO guidelines, the rat is the test animal in the carcinogenicity toxicity test (please contact for other species). The extract of the test article is administered orally for 24 weeks continuously (please contact for other methods). Test procedures include middle sacrifice, satellite group sacrifice, and test ending. The analysis includes clinical observation, hematological examination, clinical biochemistry, urine examination, organ examination, and histopathological examination.
All visible tumor tissue should be checked histopathologically to evaluate the incidence of tumors and the effects of the tumor form caused by test article. The results are used to evaluate the potential carcinogenicity that results from application of medical devices. The study provides important information on carcinogenicity caused by long-term contact with a medical device on the human body.
References:
ISO 10993-3 : Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3
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