IEC 60601-2-91:2026

Overview

IEC 60601-2-91:2026 specifies the particular requirements for the basic safety and essential performance of non-thermal plasma wound treatment equipment and associated accessories. Developed by the International Electrotechnical Commission (IEC), this international standard ensures that non-thermal plasma wound treatment devices used for chronic and acute wound care, as well as for the treatment of skin and itching diseases, operate safely and effectively without delivering heat to patients. The standard is part of the wider IEC 60601 series, focusing specifically on the unique hazards and performance expectations for these advanced medical electrical devices.

Key Topics

• Non-Thermal Plasma Technology in Medicine: The scope of IEC 60601-2-91 covers only equipment that utilizes non-thermal plasma, a partially ionized gas containing reactive species (such as ions and electrons) for therapeutic purposes. Unlike other medical devices, these do not generate heat, and are specifically designed to aid in wound treatment by leveraging the reactive species produced by plasma.

• Basic Safety Requirements: The standard outlines requirements aimed at minimizing electrical hazards such as patient leakage current, mechanical hazards, unwanted radiation, and excessive temperatures. It prescribes methodologies for testing insulating properties and limiting potential exposure to hazardous reactive species produced by the equipment.

• Essential Performance: IEC 60601-2-91 determines criteria essential for delivering reliable wound treatment. This ensures that both equipment and accessories achieve the intended physiological outcomes without introducing additional risks to patients or operators.

• Compatibility and Marking: It requires clear identification, marking, and comprehensive user documentation. Instructions for use must specify safe operating distances, compatible accessories, and any necessary warnings related to concentrations of reactive species (e.g., ozone or nitrogen oxides).

• Risk Management and Testing: The standard emphasizes systematic risk analysis, including preconditioning and testing of accessories after cleaning, disinfection, and sterilization cycles. It provides specifications for measuring patient leakage, high-frequency leakage, and ensuring that equipment insulation maintains integrity under operational conditions.

Applications

The primary applications of IEC 60601-2-91:2026 are for medical electrical devices intended for:

• Treatment of chronic and acute wounds, including hard-to-heal skin ulcers
• Therapy of diverse skin conditions and itching diseases
• Use in clinical, hospital, or outpatient care settings where non-thermal plasma devices are deployed for wound management

Non-thermal plasma wound treatment equipment offers a modern alternative to traditional thermal or electrical medical therapies. By enabling effective wound healing without the risk of thermal injury, these devices can be particularly useful for sensitive patient groups and applications where conventional treatments may not be appropriate.

Related Standards

IEC 60601-2-91:2026 is a particular standard within the IEC 60601 series. Key related documents include:

• IEC 60601-1: General requirements for basic safety and essential performance for all medical electrical equipment.
• IEC 60601-2-2 & IEC 60601-2-76: Particular standards for equipment intended for haemostasis, which are explicitly excluded from the scope of IEC 60601-2-91.
• IEC 60601-1 collateral standards: Cover broader requirements such as electromagnetic compatibility and electrical safety relevant to all medical electrical equipment.
• ISO/IEC Directives: Underpin the drafting and structure of the IEC 60601-2-91 standard, promoting harmonization with other international standards.

By adhering to IEC 60601-2-91:2026, manufacturers, healthcare providers, and regulators can ensure that non-thermal plasma wound treatment equipment meets international safety and performance benchmarks, enhancing patient safety and clinical effectiveness in advanced wound care.