IEC EN 60601-2-76 Medical Electrical Equipment - Special Requirements for Basic Safety of Low Energy Ionized Gas Hemostasis Equipment

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 60601-2-76 testing. IEC EN 60601-2-76 applies to the basic safety and basic performance of low energy ionized gas hemostasis equipment.

Low energy ionized gas hemostasis equipment refers to medical devices that use ionized gas (commonly referred to as plasma or argon plasma) to achieve hemostasis, the process of stopping bleeding. These devices are commonly used in surgical procedures to coagulate and seal blood vessels and reduce bleeding during and after surgery.

The IEC EN 60601-2-76 standard was developed to ensure the safety of patients, healthcare professionals and operators using low energy ionized gas hemostasis equipment. The standard typically covers a number of aspects, including:

• Safety of Ionized Gas: Addressing the safe production and control of ionized gas for use in the hemostasis process. This includes ensuring that ionized gas is produced and delivered in a way that minimizes the risk of injury to patients and operators.
• Electrical Safety: Establishing electrical safety requirements to prevent electrical hazards such as electrical shock, burns, and other electrical risks associated with equipment.
• Gas Handling and Distribution: Outline the requirements for delivery of ionized gas to the surgical site, including gas flow rates, pressure, and temperature considerations.
• Patient and Operator Safety: Defining precautions to protect patients, operators and healthcare personnel from the potential hazards associated with the use of ionized gas hemostasis equipment.
• Performance Requirements: Specifying performance criteria that equipment must meet in order to provide effective and reliable hemostasis. This includes factors such as coagulation efficiency, gas concentration and treatment time.
• Usability and Ergonomics: Addressing user interface design, controls and screens to ensure equipment is user-friendly and provides clear information to operators.
• Labeling and Instructions: Require manufacturers to provide comprehensive user manuals, maintenance guidelines, and safety labels that guide users in proper operation, maintenance, and safety precautions.
• Quality Assurance: Outline procedures for testing, quality assurance and maintenance of equipment to ensure continued safety and performance.

It is critical that manufacturers of low energy ionized gas hemostasis equipment comply with this standard to ensure their products are safe, effective and reliable for medical use. Healthcare providers rely on these standards to select and use equipment that meets required safety and quality standards.

EUROLAB assists manufacturers with IEC EN 60601-2-76 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.