Historical
BS EN 61010-2-040:2005
Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (British Standard)
1 Scope and objectThis clause of Part 1 is applicable except as follows:1.1.1 Equipment included in scopeReplacement: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, andd) washer disinfectors.1.1.2 Equipment excluded from scopeAdd 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.Add the following new second paragraph:This standard also does not apply to the following types of equipment:aa) equipment for use in hazardous gas atmospheres (see IEC 60079) except for an atmosphere created inside equipment by the use of a flammable sterilizing agent (see 13.0);bb) environmental cabinets (see IEC 61010-1);cc) laboratory equipment for the heating of materials for other purposes than sterilization or disinfection (see IEC 61010-2-010);dd) laundry equipment (see IEC 60335, Parts 2-4, 2-7, and 2-11, and ISO 10472), unless designed for disinfecting medical materials;ee) dishwashers (see IEC 60335, Parts 2-5 and 2-58).
Content Provider
British Standards Institution [bsi]
