ISO 22612:2016 specifies a test method for assessing the resistance to penetration through barrier materials of bacteria-carrying particles.

ISO 22612:2016 is an international standard that provides a test method for evaluating the resistance of barrier materials to the penetration of bacteria-carrying particles. This is particularly important for assessing materials used in Medical Devices, Personal Protective Equipment (PPE), and other applications where preventing the transmission of infection is crucial. The test involves exposing the material to a bacterial aerosol and measuring how effectively it prevents the penetration of these particles. This helps manufacturers ensure that their products offer the necessary protection against bacterial contamination in environments where hygiene and safety are critical, such as healthcare settings.

While ISO 22612:2016 is essential for compliance with certain regulatory frameworks, such as the European Union’s Medical Devices Directive (93/42/EEC), it is not typically suitable for routine quality control due to its complexity. The test requires strict environmental controls and precise measurements, making it more appropriate for research and development or regulatory assessments rather than day-to-day manufacturing processes. Despite this, the standard remains a valuable tool for manufacturers looking to ensure their products meet the required safety and performance standards, particularly in the development of new materials or the enhancement of existing protective products.