Toxicology tests for in vitro diagnostics
Toxicology tests for medical devices intended for in vitro diagnostics are to be performed in order to determine any possible harmful effect of a material or device on the human body, caused by a toxicity factor. These tests have to be performed for medical devices intended for immediate contact with the human body, when used as per the intended indications in accordance with the manufacturer’s documentation. Medical devices intended for immediate contact with the human body are devices and accessories which:
- are in direct contact with the human body (applied parts);
- are temporarily inserted into the human body externally;
- are to be implanted into the human body.
Medical devices for in vitro diagnostics are intended for in vitro investigation of samples taken from the human body exclusively or primarily for the need to obtain information which may be useful for further diagnostics, monitoring or for compatibility evaluation purposes; those devices include containers for sample collection and storage, and any associated instruments, devices or other related items. Such devices are not considered as temporarily inserted or implanted devices [1,2].
That is why toxicology tests for medical devices for IVD are performed only if immediate contact with the human body is intended. Such devices may come into contact with human blood, mucosa or skin. Examples of such medical devices for IVD include test strips for blood glucose concentration determination, lancets for capillary blood sampling, and various containers for biomaterials sampling and storage, such as saliva sampling containers . All medical devices for an IVD subject of toxicology tests shall undergo the same kind of test procedures as non-IVD devices. The procedure involves the following tests:
- a) physico-chemical properties;
- b) sanitary and chemical properties.
- c) biological tests in vitro and in vivo.
Toxicology tests of medical devices for IVD are to be conducted in a certified laboratory within no more than 30 days following the provision of all necessary documentation and samples for the test in question and following the provision of the test program. The testing schedule may be extended but not for more than 20 days.
Toxicology tests are considered to be negative in the following cases :
- When the medical devices tested do not comply with the intended purpose and/or intended indications for use, as stated by the manufacturer in its related operational documentation for the medical device concerned.
- When adverse reactions are identified during the test which are not specified in the IFU or in the operational manual for the medical device tested, or when adverse reactions are reported during the use of the device.
- When facts and circumstances are identified which pose a hazard to the life and well-being of the general public and health care professionals, in the event of the use and/or operation of the medical device.
- Order N 2n dated 9 January 2014 “On approval of the procedure for conformity assessment of medical devices in the form of technical tests, toxicological studies, and clinical trials for the marketing authorisation of medical devices”
- GOST R 51088-2013 In vitro diagnostic medical devices. Reagents, kits, the test-systems, control materials, culture media. Requirements for devices and for the supporting documentation
- GOST 31214-2016 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity.
- GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and investigation.