What is EN 60601-2-10:2012?

EN 60601-2-10:2012 is a technical standard that specifies the requirements for the safety and essential performance of medical electrical equipment. It focuses on the basic safety and essential performance requirements for nerve and muscle stimulators, which are devices used for diagnostic, therapeutic, and monitoring purposes in medical settings.

Scope of EN 60601-2-10:2012

This standard applies to nerve and muscle stimulators intended for use on human patients. It covers both invasive and non-invasive devices that deliver electrical stimuli to nerve or muscle tissue. The scope of this standard includes various types of stimulators, such as transcutaneous electrical nerve stimulation (TENS) devices, neuromuscular electrical stimulators (NMES), and other similar devices used in medical practice.

Safety Requirements under EN 60601-2-10:2012

EN 60601-2-10:2012 emphasizes the safety of both patients and operators using nerve and muscle stimulators. It sets forth requirements related to electrical safety, mechanical safety, radiation protection, and usability. The standard covers aspects like electrical leakage, insulation resistance, temperature limits, and electromagnetic compatibility to ensure safe and reliable operation of the devices.

Essential Performance Requirements

In addition to safety, EN 60601-2-10:2012 also addresses the essential performance of nerve and muscle stimulators. These devices should be designed to provide accurate and reliable stimulation parameters, appropriate physiological responses, and clear indications to users. The standard outlines requirements related to output characteristics, display accuracy, and alarm systems to fulfill the essential performance criteria.