What is EN ISO 10079-6:2021?

EN ISO 10079-6:2021 is an international standard that sets guidelines for the safe handling and management of medical suction equipment. This standard provides recommendations for manufacturers, healthcare professionals, and users to ensure the quality and performance of these devices.

Scope and Purpose

The scope of EN ISO 10079-6:2021 covers the design, manufacturing, testing, labeling, and maintenance of medical suction equipment. Its purpose is to establish minimum requirements that promote patient safety and prevent potential hazards associated with the use of these devices.

Key Requirements

This standard emphasizes several key requirements that need to be fulfilled by manufacturers and healthcare facilities. Firstly, it addresses the need for clear and concise instructions for use, including proper installation, operation, and maintenance procedures. It also highlights the importance of regular inspection and calibration to ensure accurate suction pressure. Furthermore, the standard stresses the need for proper documentation, including device identification, traceability, and recording of maintenance and repair activities.

Benefits and Implications

EN ISO 10079-6:2021 plays a crucial role in improving patient safety and the overall quality of care provided by healthcare facilities. By adhering to this standard, manufacturers can produce reliable and effective suction equipment, reducing the risk of malfunctions or accidents during usage. Healthcare professionals benefit from standardized protocols and guidelines, enabling them to safely handle and maintain these devices. Patients can have confidence in the performance and safety of suction equipment, ensuring effective procedures and better outcomes.