Toxicological Risk Assessment medical devices

Toxicological studies (risk assessment)of the medical divice are carried out with respect to the product, which contacts the human body when using it in accordance with the purpose provided by the manufacturer's documentations.

These products include:
a) a medical device and (or) accessories to the medical product in contact with the surface of the human body;

b) a medical device temporarily entered into the human body from the outside;

c) Medical product implanted in the human body.

Toxicological studies of the medical product are carried out to assess the biological action of the medical product on the human body and include checking the following indicators:

a) physico-chemical;

b) sanitary-chemical;

c) biological in in vitro and in vivo.

The program of toxicological studies is drawn up by a accredited laboratory together with the applicant and is approved by the head of the accredited laboratory conducted toxicological studies.

Medical products of a single (disposable) application produced in sterile form are subjected to studies for sterility with a positive result of the analysis of methods and conditions of sterilization, as well as methods for their validation and control by the manufacturer.

Medical products in contact with blood and its components, as well as substances for intravascular administration, are subject to
 toxicological studies for pieces and hemocompatibility 

Toxicological studies must determine:

a) the compliance of the medical product with the requirements of applicable national (international) standards, regulatory documentation, technical and operational documentation of the manufacturer;

b) compliance with the applicant's documentation with the requirements of applicable national (international) standards and regulatory documentation for a medical product;

c) the completeness and objectivity of the manufacturer of the characteristics to be controlled by the technical and operational documentation to be controlled during the toxicological studies of the medical product, as well as research methods;

d) safety of the use of the medical product.

The cost of toxicological tests depends on:

a) the risk of the use of the medical product;
b) the appointment of a medical product;
c) the number of execution of samples declared in the manufacturer's technical documentation;
d) methods of testing medical products.



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