What is EN ISO 10993-3:2021?

The international standard EN ISO 10993-3:2021, titled "Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity," provides guidelines for evaluating the potential risks associated with medical devices in terms of their effects on genetic material, carcinogenesis, and reproduction. This standard is one part of a series of standards published by the International Organization for Standardization (ISO) that collectively address the biological safety assessment of medical devices.

Testing for Genotoxicity

Genotoxicity refers to the ability of a substance to damage DNA, potentially leading to genetic mutations or other harmful effects. The EN ISO 10993-3 standard outlines various tests that can be conducted to assess the genotoxic potential of a medical device. These tests include assays to detect gene mutations, chromosomal aberrations, and DNA damage. By subjecting medical devices to these tests, manufacturers can determine whether the device has the potential to cause genetic harm.

Evaluating Carcinogenicity

Carcinogenicity testing involves assessing the potential of a substance or device to induce cancer. The EN ISO 10993-3 standard provides recommendations for evaluating the carcinogenicity of medical devices, including both in vitro and in vivo test methods. In vitro tests involve exposing cells or tissues to the device or its extracts, while in vivo tests use animals to assess the long-term effects of the device. Through these tests, manufacturers can identify any potential carcinogenic risks associated with their products.

Assessing Reproductive Toxicity

Reproductive toxicity refers to the potential of a substance or device to cause adverse effects on fertility or development. The EN ISO 10993-3 standard includes guidelines for evaluating the reproductive toxicity of medical devices, taking into account both male and female reproductive systems. The testing may involve assessing sperm quality, embryo implantation, or fetal development, among other parameters. By conducting these tests, manufacturers can ensure that their devices do not pose risks to human reproduction.