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
|Publication Date:||1 July 2015|
|ICS Code (Laboratory ware and related apparatus):||71.040.20|
|ICS Code (Electrical and electronic testing):||19.080|
|ICS Code (Chemical laboratories. Laboratory equipment):||71.040.10|
Scope and object
Equipment included in scope
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.
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).
Aspects included in scope
Replace item g) and the note by the following new text and note:
g) liberated gases (including the non-intentional escape of toxic gas), pathogenic substances, explosion and implosion (see Clause 13).
NOTE Attention is drawn to the existence of additional requirements which may be specified by national authorities responsible for the health and safety of labour forces. In particular, national and other regulations or codes apply for the safety of automatic loading and unloading systems.
Aspects excluded from scope
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 and PRESSURE VESSELS.