IEC 60601-1 - Medical Electrical Equipment Safety 7.2: Marking on the outside of ME equipment or ME equipment parts

What does 7.2 require?

The outside of the equipment carries the markings of 7.2.2 to 7.2.21, and where size or enclosure prevents the full set, at least the identification, other-equipment power marking, mains connection marking (not for permanently installed equipment), applied part symbols and physiological effect signs, the rest recorded in the accompanying documents or, where nothing is practicable, on the individual packaging; single-use items or their packaging are marked as such. Identification carries the manufacturer's name or trademark and contact information, the type or model reference, a serial, lot or batch identifier, and where applicable the use-by date or the manufacturing date, detachable components the name and reference unless misidentification carries no unacceptable risk, and PEMS software a unique identifier available to designated persons; accessories are marked the same way or on their packaging. Where consulting the documents is mandatory the ISO 7010-M002 sign is used; where power comes from other equipment and safety depends on it, the specified equipment is named at the connection point, the mandatory sign placed with the details in the instructions, or a non-standard connector used. Mains connection marking gives the rated supply voltage or ranges (hyphen for a range, solidus between alternatives), the nature of supply, rated frequency, and the class II symbol where applicable, on the part containing the mains connection; rated input is marked in amperes, volt-amperes or, above power factor 0.9, watts, at both limits of ranges wider than 10 percent of the mean, with long-time and momentary ratings both identified and any outlets' rated output included. Power output connectors carry rated voltage, current or power and frequency; IP classification is marked unless IPX0 or IP0X; applied parts carry the type B, BF or CF symbol and the defibrillation-proof symbols where applicable, adjacent to or on the connector or on the part, with a warning sign where defibrillator protection depends on the patient cable; duty cycle is marked for non-continuous operation; accessible fuse-holders carry the fuse type and full rating; non-obvious physiological effects carry a safety sign with the hazard and precautions explained in the instructions; tool-free accessible high-voltage terminals carry the high-voltage symbol; cooling requirements, packaging handling and transport and storage conditions, sterile packaging and its method, rated maximum supply pressure and flow at pressure inputs, functional earth terminals, and removable protective means needing replacement are marked; and mobile equipment is marked with its mass including safe working load, distinct from bin or shelf loading. Compliance is checked by inspection together with the 7.1 durability and legibility tests.