What is EN ISO 10993-17: 2014 ?

EN ISO 10993-7: 2014 is an essential international standard that provides guidelines for evaluating the biological effects of medical devices on living organisms. The standard specifically focuses on the assessment of the local effects of materials used in medical devices when placed in direct or indirect contact with the human body. It aims to identify and evaluate any potential adverse reactions at the site of contact, such as irritation, inflammation, or cell damage.

The standard provides guidelines for conducting tests to determine the material's cytotoxicity, sensitization potential, and irritation properties. It also has specific requirements for the assessment of the potential adverse effects of materials used in medical devices.

One of the main objectives of EN ISO 10993-7: 2014 is to determine if a material used in a medical device can cause adverse biological reactions in humans. The standard emphasizes the importance of conducting thorough evaluation to identify any potential risks associated with these materials.

The standard sets out the following key requirements:

* The materials used in medical devices must be selected based on their biocompatibility and evaluated for their potential adverse effects.

* The materials used in medical devices must be tested in a controlled environment to determine their cytotoxicity, sensitization potential, and irritation properties.

* The tests must be conducted by experts who have experience in the relevant fields.

* The results of the tests must be interpreted and reported by the testing team.

EN ISO 10993-7: 2014 is an important international standard that provides a framework for evaluating the biological effects of medical devices on living organisms. It is essential for medical device manufacturers, clinicians, and regulatory authorities to ensure that medical devices are safe and compatible with human beings.