IEC 61010-2-040-2015 测量、控制和实验室用电气设备的安全要求--第2-040部分：处理医疗材料用灭菌器和洗涤机消毒器的特殊要求 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat

1.1.1 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 1.4.
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.
1.1.2 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.
Addition:
Add the following new second paragraph:
This part of IEC 61010 does not apply to the following types of equipment:
aa) equipment for use in hazardous atmospheres (see IEC 60079) but does apply to an atmosphere created inside equipment by a flammable sterilizing agent (see 13.0);
bb) laboratory equipment for the heating of materials for other purposes than sterilization or disinfection (see IEC 61010-2-010);
cc) laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and ISO 10472), unless designed for disinfecting medical materials;
dd) dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).dition 2.0 2015-07 INTERNATIONAL STANDARD NORME INTERNATIONALE GROUP SAFETY PUBLICATION PUBLICATION GROUPéE DE SéCURITé 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 Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire – Partie 2-040: Exigences particulières pour stérilisateurs et laveurs dési