ISO 80601-2-71 Medical Electrical Equipment - Part 2-71: Functional Near Infrared Spectroscopy (NIRS) Equipment Testing

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 80601-2-71 testing. The ISO 80601-2-71 standard specifies a process for a manufacturer to analyze, determine, develop and evaluate the safety usability of a medical equipment. This process allows the manufacturer to assess and reduce the risks associated with correct handling and processing errors, ie normal use.

A 'Special guidance and rationale' text, with some explanatory notes on the more important requirements where appropriate, is included in Annex AA. It is thought that knowing the reasons for these requirements will not only facilitate the correct application of the standard, but also accelerate any revisions required by changes in clinical practice or developments in technology over time. However, this annex does not form part of the requirements of this standard.

Not covered by this particular standard:

• The portion of the ME EQUIPMENT, if any, that measures the oxygen saturation of hemoglobin in microvessels (capillaries, arterioles and venules);
• Near infrared spectroscopy (NIRS) tissue oximetry equipment not intended to output functional NIRS equipment;
• Pulse oximetry equipment not intended to output functional NIRS equipment. Pulse oximetry equipment requirements are found in ISO 80601-2-61;
• Frequency domain and time domain equipment for functional near infrared spectroscopy that may require test procedures other than those described herein;
• Functional near-infrared spectroscopy equipment that measures changes in the concentration of chromophores other than oxy- and deoxy-hemoglobin, which may require test procedures other than those described here.

EUROLAB assists manufacturers with ISO 80601-2-71 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.