International Electrotechnical Commission

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 - Edition 2.0
 N 61010-2-040

Annotation

Scope and object

Equipment included in scope

Replacement:

This International Standard 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 1.4.

Examples of such equipment are:

a) STERILIZERS and disinfectors using steam;

b) STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour;

c) STERILIZERS and disinfectors using hot air or hot inert gas, and

d) washer disinfectors.

Equipment excluded from scope

Add the following note to item g)

NOTE IEC 60601-1(definition 2.2.15 modified) 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.