What is EN ISO 10079-4: 2021 ?

EN ISO 10079-4: 2021 is a technical standard designed to ensure the safety and reliability of medical supply units. specifically in relation to their electrical safety. This international recognized standard was developed by the European Committee for Standardization (CEN) and the International Organization for Standardization (ISO) and focuses on medical suction equipment used in healthcare settings. promoting consistent performance. reliability. and patient safety across various devices.

EN ISO 10079-4: 2021 provides comprehensive guidelines regarding the construction. performance. and testing of medical suction equipment. outlining specific parameters for flow rate. vacuum pressure. and sound level. It also emphasizes the importance of user instructions and labels. which are crucial for proper device operation and preventing potential hazards.

By complying with EN ISO 10079-4: 2021. medical supply unit manufacturers can assure healthcare professionals and patients alike that their devices are safe to use. preventing potential hazards such as electric shocks. fires. or malfunctions that could jeopardize patient safety and compromise the efficiency of medical procedures.

EN ISO 10079-4: 2021 plays a vital role in ensuring the safety and reliability of medical supply units. and it is essential for medical device manufacturers to understand its requirements and guidelines. By adhering to this standard. manufacturers can create products that meet the necessary safety standards. ultimately protecting the well-being of patients and ensuring the efficiency of healthcare settings.