Genotoxicity, carcinogenicity and reproductive toxicity according to the ISO 10993 standard

The manufacture of medical devices is subject to numerous standards and legal regulations worldwide. As an industry that has to do with human health and does not allow for negligence, all phases, starting with research and development, experience, professionalism and professional support are in demand. Before a medical device can be launched, it must go through a legal process. In this context, various controls and laboratory analyzes are in the foreground. On the basis of the ISO 10993 standard, a procedure that meets the requirements of FDA must be carried out.

Before we go into the studies on “genotoxicity, carcinogenicity and reproductive toxicity” in our article, we first want to clarify how many classes are medical devices and which class is relevant for the tests mentioned.

How many classes are medical devices classified?

According to the classification system specified by the FDA, 1700 types of medical devices are divided into 16 medical specialties. Each of these products is divided into one of three classes, depending on the potential risk to patients, type of product, scope and duration of use.

– Class 1 - Medical equipment: stethoscopes, bandages, bed accessories, latex gloves, surgical masks

Medical devices of this class are considered devices with the lowest risk. Therefore, they are subject to less strict control procedures compared to the general procedure.

– Class 2 - Medical Devices: Blood Pressure Cuffs, Pregnancy Tests, Syringes, Blood Transfusion Devices, Motorized Wheelchairs, Contact Lenses, Specific Diagnostic Software

This class includes 43% of Medical Products and includes medium-risk products. In addition to the general controls, you will need to go through special controls on performance, labeling, clinical test data, and conformity requirements.

– Class 3 - Pacemakers, Defibrillators, Implant Prostheses, Cochlear Implants, Breast Implants, Intraocular Lenses, Kidney Stents

These products of the highest risk group are subjected to stricter testing and analysis procedures and must go through all certification levels in full. They are subject to general controls and approval prior to placing on the market.

Things to know about genotoxicity studies

The DRH (Center for Devices and Radiological Health) and the CBER (Center for Biologics Evaluation and Research) require genotoxicity tests for medical devices longer than 24 come into contact with bones, mucous membranes or other tissues for hours to 30 days or more. In addition, this can also be required for medical devices that have already been legally marketed, regardless of their useful life. For products with a large surface area and thus increased potential for chemical leakage and products that come into contact with blood outside the body, genotoxicity testing may be required if there is a possibility of substances entering the systemic circulation.

If an in vitro genotoxicity test on mammalian cells is required:

If an in vitro genotoxicity test is required:

These tests must be performed with the support of authorized and accredited laboratories.

Carcinogenicity Testing of Medical Devices and Details

In addition to products that are used for wound healing (which come into contact with damaged or injured surfaces), products that come into contact with the outdoor environment and are implanted must also be tested for carcinogenicity. The FDA recommends checking your carcinogenicity potential for medical devices that come into contact with the body for more than 30 days. Even if a product passes the genotoxicity test, it should be tested for carcinogenicity. In this case, it should be considered that no genotoxic carcinogens can be present and that the carcinogenic effect depends on various factors.

Why is the reproductive toxicity of medical devices assessed?

The potential impact on reproductive function, embryonic development (teratogenicity) and prenatal and early postnatal development must be examined in medical devices and materials. This includes the following medical devices:

– Implant materials in which chemical leaks may come into contact with the reproductive organs. In this case, the nature or duration of the contact does not matter.

– Materials or components of products that come into contact with the reproductive organs

For further information on the ISO 10993 standard and the work carried out under this standard, as well as for support in the certification, testing and analysis of your products, please feel free to contact us. Our team of experts will be happy to answer any questions you may have on this topic.