Instituto Valenciano de Microbiología
(IVAMI)

Masía El Romeral
Ctra. de Bétera a San Antonio Km. 0.3
46117 Bétera (Valencia)
Phone. 96 169 17 02
Fax 96 169 16 37
Email: 
www.ivami.com
CIF B-96337217

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Acute systemic toxicity test by dermal route (UNE-EN ISO 10993-11: 2018 Standard). Biological evaluation of medical devices. Systemic toxicity tests.

Test accredited by ENAC (Spanish National Accreditation Entity).

 

Test with the certificate of Good Laboratory Practices (GLPs).

The release of chemicals from a medical device into the body can cause systemic toxicity. The acute systemic toxicity test provides general information on the physiological risks that may arise after acute exposure of a medical device to the relevant clinical pathway. Medical devices or their releasable substances can enter the body through multiple routes of exposure and, whenever possible, the most clinically appropriate route of exposure for use of the device should be chosen for the acute systemic toxicity test. Dermal acute systemic toxicity tests are appropriate for surface devices.

The animals used in this test are young adult rodent or non-rodent. For the evaluation of acute systemic toxicity by dermal route, groups of 5 animals are used in the case of rodents (rat, mouse) and 3 animals in the case of non-rodents. If non-rodents are used it must be scientifically justified. When the intended use of a medical device is for one sex only, tests should be carried out on animals of that sex. Animals are administered with the medical device directly or with extracts of the medical device obtained with polar and non-polar solvents, and their corresponding controls, the solvents not exposed to the product. Animals receive a single dose of sample or, if necessary, multiple dose fractions over a 24 hour period. The client must choose the time and frequency of application according to the intended use of the medical device, as well as the observation period.

The animals are observed daily for at least three days, in which the appearance of side effects are studied: adverse clinical signs, change in body mass, serious pathological findings and/or death of the study subjects. The frequency and duration of the observations can be adjusted depending on the nature and severity of the toxic reactions, the initial rate and the recovery time.

The medical device is considered to pass the test if none of the test animals shows a biological reaction significantly greater than that observed in the control animals. If two or more of the five test animals die, or show signs of toxicity (clinical observation), or three or more of the animals lose more than 10% of their body weight, the test product does not meet the test requirements. If one of the animals inoculated with the product shows signs of a slight biological reaction, or one of the animals shows significant signs of a biological reaction or dies, the test should be repeated with groups of 10 mice. If in the repeat test with 10 mice none show signs of significant biological reactivity, compared to the respective controls, the test product meets the requirements of the test.

In addition, the client can request the extension of the study through hematological, biochemical, or macroscopic pathology analyzes, indicated in the case of testing medical devices whose expected toxicity is based on an existing study or on new materials for which no previous experience is available. If you are interested in carrying out these analyzes, ask us for more information.

Besides to the tests on rodents, indicated as priority test animals for acute systemic toxicity tests by the UNE-EN ISO 10993-11 standard, the standard also contemplates that systemic toxicity studies for dermal administration can be performed in rabbits In case you want to carry out the acute systemic toxicity test by dermal route in rabbits, ask us for information.