What is BS EN ISO 10993-17:2014 ?

EN ISO 10993-7:2014 is an essential standard for medical devices that aims to ensure the safety and compatibility of these devices with human beings. The standard, issued by the International Organization for Standardization (ISO), focuses on evaluating the biological effects of medical device materials on living organisms.

In direct or indirect contact with the body, medical devices can cause adverse reactions, such as irritation, inflammation, or cell damage. EN ISO 10993-7:2014 provides guidelines for assessing the potential risks associated with medical device materials and for identifying any potential adverse reactions at the site of contact.

The main objective 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.

To evaluate the biocompatibility of a material, EN ISO 10993-7:2014 provides several key requirements. First, materials must be tested for their cytotoxicity, sensitization potential, and irritation properties. Second, the standard requires that tests be conducted in a controlled environment, such as a bioreactor, to ensure that the material's effects are accurately evaluated.

Third, the standard requires that the testing be conducted on a representative sample of the material being evaluated. This ensures that the material's properties are evaluated using the same material and in the same way.

Lastly, EN ISO 10993-7:2014 requires that the results of the testing be documented and reported to the relevant regulatory authorities. This documentation helps ensure that the material is properly evaluated and that any potential risks are identified and addressed.

In conclusion, EN ISO 10993-7:2014 is an essential standard for medical devices that aims to ensure the safety and compatibility of these devices with human beings. The standard provides guidelines for evaluating the potential adverse effects of medical device materials on living tissue and for identifying any potential adverse reactions at the site of contact. By following the guidelines provided by EN ISO 10993-7:2014, medical device manufacturers can ensure that their products are safe and effective for use.