What is EN ISO 10993-2:2021?

EN ISO 10993-2:2021 is a technical standard developed by the International Organization for Standardization (ISO) that pertains to biological evaluation of medical devices. The standard specifically focuses on the testing of animal welfare and ethical considerations related to using animals in the development and testing of medical devices.

The Scope of EN ISO 10993-2:2021

The scope of EN ISO 10993-2:2021 covers the evaluation and testing requirements for medical devices intended to come into contact with animals for any duration of time. These may include materials used in implants, surgical equipment, anesthesia apparatus, and diagnostic devices.

The standard outlines the considerations and procedures for testing biological compatibility and evaluating the potential risks associated with exposure to animals. It provides guidelines for researchers and manufacturers to conduct appropriate testing to ensure safety and compliance with regulatory requirements.

Biological Evaluation Testing

In line with EN ISO 10993-1, the standard requires conducting various tests to assess the biocompatibility of medical devices, specifically their effects on living organisms and tissues. These tests aim to determine whether the device's components or extracts cause any harmful biological reactions, such as irritation, sensitization, systemic toxicity, or genotoxicity.

The standard specifies various biological test methods that can be employed, including in vitro tests using animal cells or tissues, in vivo tests on animals, and chemical characterization of the materials used in the device. The selection of tests depends on the device's type, intended use, and contact duration.

Animal Welfare and Ethical Considerations

EN ISO 10993-2:2021 emphasizes the importance of considering animal welfare and ethical principles when conducting testing on animals. Animal welfare should be a priority, and researchers must follow proper procedures to minimize suffering and maximize the use of alternative testing methods whenever possible.

The standard encourages the use of recognized ethical principles in experimental design and requires researchers to consider the three Rs: Replacement, Reduction, and Refinement. These principles advocate for replacing animals with alternative testing methods, reducing the number of animals used, and refining techniques to minimize pain and distress for the animals involved.