What is EN ISO 10993-22:2021?

EN ISO 10993-22:2021, also known as Biological evaluation of medical devices - Part 22: Guidance on permitted limits for volatile organic compounds (VOCs) in medical device extracts, is an international standard that provides guidance on the evaluation of the potential health hazards associated with the presence of volatile organic compounds in medical devices.

The Importance of Evaluating VOCs in Medical Device Extracts

Volatile organic compounds are chemicals that easily evaporate at room temperature and can be released from various materials, including those used in the manufacture of medical devices. When these compounds come into contact with human tissues or body fluids, they can potentially pose health risks. Therefore, it is crucial to evaluate and control the levels of VOCs in medical device extracts to ensure their safety and minimize any potential harm to patients.

Evaluating VOCs According to EN ISO 10993-22:2021

EN ISO 10993-22:2021 provides a standardized approach for assessing the presence of VOCs in medical device extracts. The standard establishes limits for specific VOCs based on their toxicological properties and recommends appropriate analytical methods for their detection and quantification. It also guides manufacturers on how to interpret the results obtained and suggests actions to be taken if the VOC levels exceed the permissible limits.

Implementing EN ISO 10993-22:2021 in the Medical Device Industry

The implementation of EN ISO 10993-22:2021 in the medical device industry plays a crucial role in ensuring patient safety. Manufacturers need to perform thorough risk assessments and conduct appropriate testing to comply with the standard's requirements. By adhering to these guidelines, they can identify potential risks associated with VOCs in medical devices, mitigate them through improved material selection or manufacturing processes, and ultimately deliver safer products to healthcare providers and patients.