IEC 60601-2-57 Ed. 2.0 b:2023— Medical Electrical Equipment

Patients in hospitals can be exposed to electromagnetic fields and optical radiation. This exposure may be associated with risks and hazards. IEC 60601-2-57 Ed. 2.0 b:2023— Medical Electrical Equipment – Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring, Cosmetic And Aesthetic Use provides requirements for protection against hazards resulting from the operation of light source medical equipment.

What Is Optical Radiation?

Optical radiation extends between microwaves and X-rays of the electromagnetic radiation and includes ultraviolet (UV), visible light (VL), and infrared (IR) components. People who expose themselves to excess optical radiation—either of natural origin (the sun) or of artificial generation (e.g., in lasers, lamps, radiant heaters, sunbeds, electric arcs, etc.,)— can damage their skin and eyes. The effects on the skin range from redness, burning, and accelerated aging through to various types of skin cancer.

What Is IEC 60601-2-57 Ed. 2.0?

IEC 60601-2-57 Ed. 2.0 b:2023 applies to basic safety and essential performance of medical electrical equipment. The standard establishes the risk from optical radiation and specifies basic safety and essential performance requirements for light source equipment. It provides warning to individuals of risks associated with accessible optical radiation light source equipment through signs, labels, and instruction. IEC 60601-2-57 Ed. 2.0 b:2023 also specifies requirements for the manufacturer to supply information and establish procedures so proper precautions can be adopted.

Light Source Equipment in the Scope of IEC 60601-2-57 Ed. 2.0

Equipment in the scope of IEC 60601-2-57 Ed. 2.0 b:2023 incorporates one or more sources of optical radiation in the wavelength range 200 nm to 3,000 nm, with the exception of laser radiation. This electrical equipment is also intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications.

Optical Radiation in Medical Devices

Light and optical techniques have made profound impacts on modern medicine. For example, there are numerous lasers and optical devices used in clinical practice to assess health and treat disease. The practical benefits of optical technologies include low cost, compactness, suitability for point-of-care use, and positive safety profile—especially for their fundamental properties of molecular sensitivity/specificity and wavelengths on the order of cellular/tissues and structures. Hence, optical technologies are found throughout medical practice:

• Primary care (e.g., otoscopy, pulse oximetry, bilirubin monitoring in neonates)
• Diagnostics (e.g., endoscopic, dermatological, ophthalmological imaging)
• Intervention guidance (e.g., surgery and cardiology)
• Light-based therapeutics (e.g., surgical, dermatological and ophthalmological lasers, photodynamic therapy, and phototherapy)

Applications of Optical Imaging Technology

Rising clinical research, increasing geriatric population, and growing utility of optical imaging techniques in medical diagnosis have increased the demand for optical imaging: a technique for non-invasively looking inside the body, as is done with x-rays. Unlike x-rays, which use ionizing radiation, optical imaging uses visible light and the special properties of photons to obtain detailed images of organs, cells, and even molecules. The techniques offer minimally or non-invasive methods for looking inside the body.

These images are used by scientists for research and by clinicians for disease diagnosis and treatment. Specifically, advanced medical devices and diverse novel optical imaging is being studied for the screening and treatment of neurological damage, glaucoma, and in multiple therapeutic areas such as ophthalmology, oncology, and dermatology. Additionally, Non-invasive optical imaging techniques are being developed for breast cancer chemotherapy monitoring.

IEC 60601-2-57 Ed. 2.0 b:2023— Medical Electrical Equipment – Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring, Cosmetic And Aesthetic Use is available on the ANSI Webstore.