1 Scope and object
This clause of Part 1 is applicable except as follows:
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 60601-1defines 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).
1.2.1 Aspects included in scope
Replacement:
Replace item g) with the following new text:
-
g) liberated gases (including the non-intentional escape of toxic gas), pathogenic substances, explosion and implosion (see Clause 13).
1.2.2 Aspects excluded from scope
Addition:
Add the following two new items:
-
aa) special requirements for protection against chemical and high-risk micro-biological hazards associated with the load;
-
bb) general requirements for the design of calorifiers, shell boilers and pressure vessels.
NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers andpressure vessels (see 14.101).