Introduction
Introduction
P0-9
Precautions: use of medical electrical system
Situation No.
Medically used room
Non-
medically
used room
Examples of
possible causes
for exceeding
LEAKAGE
CURRENT limits
Practical means of
compliance
Apply 16.5 in all
situations
Inside the
PATIENT
ENVIRON-
MENT
Outside the
PATIENT
ENVIRONMENT
2
2a Items A and
B are ME
EQUIPMENT
No causes of ex-
ceeding LEAKAGE
CURRENT
- No further mea-
sures are neces-
sary
2b Items A and
Item B are ME
EQUIPMENT
powered via
a MULTIPLE
SOCKET-
OUTLET
Earth conductor
of the MULTIPLE
SOCKET-OUTLET
is broken
- Additional
PROTECTIVE
EARTH CON-
NECTION (for A
or B) or,
- Separating trans-
former
2c Item A is ME
EQUIPMENT
and Item B
is non-ME
EQUIPMENT
Due to high TOUCH
CURRENT of B
See rationale for
16.5.
- Do not use metal
connector hous-
ing or,
- SEPARATION
DEVICE
2d Item A is ME
EQUIPMENT
and item B
is non-ME
EQUIPMENT
powered via
a MULTIPLE
SOCKET-
OUTLET
The earth conductor
of the MULTIPLE
SOCKET-OUTLET
is broken
- Additional
PROTECTIVE
EARTH CON-
NECTION (for A
or B) or,
- Separating trans-
former
3
3a Items A and
B are ME
EQUIPMENT
No causes of ex-
ceeding LEAKAGE
CURRENT
- No further mea-
sures are neces-
sary
3b Item A is ME
EQUIPMENT
and item B
is non-ME
EQUIPMENT
Due to high TOUCH
CURRENT of B
See rationale for
16.5.
- Do not use metal
connector hous-
ing for SIGNAL
INPUT/OUTPUT
PART or,
- SEPARATION
DEVICE
3c Item A is ME
EQUIPMENT
and item B in
is ME EQUIP-
MENT or non-
ME EQUIP-
MENT
a) Potential differ-
ence between
PROTECTIVE
EARTH CON-
NECTIONS of A
and B
b) Due to high
TOUCH CUR-
RENT of B
See rationale for
16.5.
- Additional
PROTECTIVE
EARTH CON-
NECTION for
(A), or
- SEPARATION
DEVICE, or
- Do not use
metal connector
housing in the
PATIENT ENVI-
RONMENT
NOTE 1. No causes of TOUCH CURRENT or EARTH LEAKAGE CURRENT exceeding limits.
NOTE 2. IEC 60601: MEDICAL ELECTRICAL EQUIPMENT in compliance with IEC 60601.
NOTE 3. IEC xxxxx: Non-medical equipment in compliance with relevant IEC safety standards.
NOTE 4. Separating transformer: see 16.9.2.1.
NOTE 5. If equipment “B” is outside the PATIENT ENVIRONMENT and if equipment “A” is a CLASS II equipment and has accessible con-
ductive parts connected to the PROTECTIVE EARTH CONNECTON of equipment “B” then additional safety measures could be
necessary, for example: additional protective earth for “B” or separating transformer or SEPARATION DEVICE.
A
IEC 60601
B
IEC 60601
Mains
Plug
Mains
Plug
A
IEC 60601
B
IEC XXXXX
Mains
Plug
Mains
Plug
A
IEC 60601
B
IEC 60601
MULTIPLE SOCKET-OUTLET
A
IEC 60601
B
IEC XXXXX
MULTIPLE SOCKET-OUTLET
A
IEC 60601
B
IEC 60601
Mains
Plug
Mains
Plug
Common protective earth
A
IEC 60601
B
IEC XXXXX
Common protective earth
Mains
Plug
Mains
Plug
A
IEC 60601
B
IEC 60601
B
IEC XXXXX
Mains
Plug
Mains
Plug
Common protective earth
Protective earth with
potential difference
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