The IEC 60601-2-57 standard, prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Organization for Standardization (ISO), includes one or more optical radiation sources in the wavelength range of 200 nm to 3000 nm and is a visual It describes the safety and performance criteria and test methods that should be addressed in the design and manufacture of non-imaging devices.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-57 Electrical medical equipment - Part 2-57: Specific features for the basic safety and required performance of laser weldless devices for treatment, diagnosis, imaging and cosmetic / anesthetic use.
Medical devices covered by this standard are diagnostic and monitoring devices for therapeutic purposes and devices that create photo-biological effects in humans or animals for aesthetic or veterinary applications. Sun tanning, eye tools, or baby phototherapy devices are outside the scope of the IEC 60601-2-57 standard. Light source equipment can consist of a single or multiple sources of optical radiation, with or without a power source. Or it may have a complex system that includes optical, electrical mechanical systems, or other radiation sources.
A few standards that are indispensable and referred to during the implementation of the IEC 60601-2-57 standard are: IEC 60947-3 (low voltage switchgear and controlgear, switches, disconnectors, load breakers and fuse combination units), IEC 62471 (for lamps and lamp systems photobiological safety) and ISO 3864-2 (design principles for product security labels).
Ensuring patient and operator safety is the primary goal for all medical electrical equipment covered by the standard.
Tests in accordance with IEC 60601-2-57 standard are also carried out by our organization within the scope of medical device tests.
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