IEC 60601-2-91:2026 pdf download,Medical electrical equipment – Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment.
IEC 60601-2-91:2026 specifies particular requirements for the basic safety and essential performance of non-thermal plasma wound treatment equipment and its accessories. It supplements and modifies the general requirements of IEC 60601-1, applying them specifically to equipment that uses non-thermal plasma to treat chronic or acute wounds, biological tissue, and certain skin or itching diseases without intentionally supplying heat to the patient.
The standard addresses hazards associated with the equipment’s construction, operation, plasma generation, electrical systems, mechanical parts, patient connections, accessories, controls, displays, markings, and accompanying documentation. It establishes requirements intended to control risks such as unintended energy delivery, excessive temperature, electrical shock, electromagnetic disturbances, mechanical injury, plasma-related exposure, fire, and incorrect operation. It also requires manufacturers to define essential performance, provide suitable protective measures, verify equipment behavior under normal and single-fault conditions, and supply clear instructions for installation, operation, cleaning, maintenance, inspection, and safe use.
As a particular standard, it uses the structure of IEC 60601-1:2005 and its amendments, adding, replacing, or modifying clauses where necessary. Applicable collateral standards generally remain relevant, while IEC 60601-1-3 and IEC 60601-1-10 do not apply. The document excludes equipment intended specifically for haemostasis of biological tissue, which is covered by other particular standards.