European Committee for Electrotechnical Standardization

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
 N EN 61010-2-040

Annotation

Equipment included in scope

Replacement:

Replace the existing text with the following:

This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of

Examples of such equipment include the following:

a) sterilizers and disinfectors using steam, and/or hot water as the sterilant;

b) sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;

c) sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and

d) washer disinfectors.

Equipment excluded from scope

Addition:

Add the following note to item

f): NOTE IEC 60601-1 defines medical electrical equipment as follows:

Electrical equipment, provided with not more than one connection to a particular supply MAINS and intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a patient; and that makes physical or electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or from the patient.