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VII
● Combination of medical electrical equipment and non-medical electrical equipment
IEC 60601-1-1 “Safety requirements for medical electrical systems” describes the components combination
grouped into various clinical settings. The brief overview of IEC 60601-1-1 is shown below.
Situation No.
Medically used room
Non-medically
used room
Feasible solution
(See clause 19 in all
situations)
Inside
the PATIENT
ENVIRONMENT
Outside
the PATIENT
ENVIRONMENT
1
1a Items A and B in
PATIENT ENVIRON-
MENT
A
IEC
60601
B
IEC
60601
1b Items A and B in
PATIENT ENVIRON-
MENT
A
IEC
60601
B
IEC
XXXXX
For B:Additional
protective earth or
separating transform-
er
1c Item A powerd
from specied power
supply in item B in
PATIENT ENVIRON-
MENT
A
IEC 60601
B
IEC XXXXX
For B:Additional
protective earth or
separating transform-
er
2
2a Item A in PATIENT
ENVIRONMENT and
item B in medically
used room
A
IEC
60601
B
IEC
60601
2b Item A in PATIENT
ENVIRONMENT and
item B in medically
used room
A
IEC
60601
B
IEC
XXXXX
For B:See 19.201
and its rationale
3
3a Item A in PATIENT
ENVIRONMENT and
item B in non-medical-
ly used room
A
IEC
60601
B
IEC 60601
or IEC XXXXX
For B:See 19.201
and its rationale
3b Item A in PATIENT
ENVIRONMENT and
item B in non-medi-
cally used room
A
IEC
60601
B
IEC 60601
or IEC XXXXX
For B:Additional
protective earth or
SEPARATION DE-
VICE
KEY TO TABLE
• Additional protective earth : If necessary, provide additional protective earthing , which is permanently
connected(See also 58.201).
NOTE Equipment modication may be required.
• Separating transformer : If necessary, limit the ENCLOSURE LEAKAGE CURRENT, by using an ad-
ditional separating transformer according to annex EEE.
NOTE1 No equipment modication is required.
NOTE2 A separating transformer is a transformer with one or more input winding(s) separated from the
output winding(s) by at least basic insulation [IEC 60989].
• SEPARATION DEVICE : If necessary, apply SEPARATION DEVICE.
• IEC 60601 : MEDICAL ELECTRICAL EQUIPMENT in compliance with IEC 60601.
• IEC XXXXX : Non medical equipment in compliance with relevant IEC safety standards.
Common protective earth
Protective earth
Protective earth with
potential difference