What is EN ISO 10079-6:2021?

EN ISO 10079-6:2021 is a technical standard that pertains to medical suction equipment. This international standard provides guidance and requirements for the design, testing, safety features, and performance of these devices. Medical suction equipment plays a crucial role in healthcare settings by removing unwanted fluids, secretions, or gases from a patient's body. In this article, we will explore the key aspects of EN ISO 10079-6:2021 and its implications in the medical field.

Scope of EN ISO 10079-6:2021

The standard focuses on portable, motor-driven electrical suction devices used in healthcare facilities. It covers a wide range of applications such as surgical suction, airway suction, wound drainage, and pleural drainage systems. The scope also extends to standalone devices or those integrated into larger medical systems. By establishing criteria for the safety, labeling, and user instructions of these devices, EN ISO 10079-6 ensures their proper functioning and compliance with regulatory standards.

Requirements and Testing

EN ISO 10079-6 sets out various requirements pertaining to mechanical hazards, electrical safety, and noise emission levels. It defines safety features that these devices must incorporate, including temperature monitoring, non-return valves, and pressure relief mechanisms. The standard also specifies performance requirements related to suction capacity, vacuum limiters, and flow rates. Additionally, testing methods are outlined to verify the compliance of suction equipment with the specified parameters. Manufacturers must conduct tests considering factors like accuracy, reliability, and durability.

Significance for Healthcare Facilities

Compliance with EN ISO 10079-6:2021 is essential for healthcare facilities to ensure patient safety and efficient operation of suction devices. Adhering to this standard guarantees that the medical equipment meets quality standards and minimizes risk for both patients and healthcare professionals. Proper maintenance, inspections, and calibration of medical suction equipment contribute to its longevity, reliability, and accuracy. By implementing EN ISO 10079-6:2021, healthcare facilities can enhance the overall quality of care provided to patients.