Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11

pyo

Registered
#1
Hey guys,

I have an question about scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment standard.

Is it only applicable to "Anaesthetic, respiratory and reanimation equipment" or "Homecare services in General"? Because on ISO website it ICS code indicate that it's for Anaesthetic, respiratory and reanimation equipment. Whereas on Estonian standard website, ICS code is for Homecare Services in General. Which is correct?

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Benjamin Weber

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#2
You should consider dere the scope as it is defined in the standard IEC 60601-1-11 itself. This says:

cl. 1.1 Scope
"(...) MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME
HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the
instructions for use. (...)"

cl. 3.1 HOME HEALTHCARE ENVIRONMENT
"dwelling place in which a PATIENT lives or other places where PATIENTS are present, excluding
professional healthcare facility environments where OPERATORS with medical training are
continually available when PATIENTS are present.
EXAMPLES In a car, bus, train, boat or plane, in a wheelchair or walking outdoors."

So I don't see any restriction concerning "Anaesthetic, respiratory and reanimation equipment" only. Actually it depends only on the place the ME equipment is used, not on the type of device.
 
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