A lie part B:
This applied part which provides protection against electric shock compliance with the re
quirements defined IEC 601-1, especially considering the admissible leakage current, and which
is arked follow s:
- typ earth applied art or
- type applied part protected defib rillator
A pplied parts type are not intended for being applied directly the heart.
Applied parts type are either applied parts type applied parts type CF
Note: For devices protection class this applied part connected earth which can verified
by measurement with ohmmeter.
A lie part BF:
This applied part type which provides more significant protection against electric shock
than applied parts type compliance with the requirements defined IEC 601-1 and which
is arked follow s:
type BF: applied part isolated from earth or
type BF: applied part protected defib rillator
A pplied parts type are not intended for being applied directly the heart. According to
IEC 60601-1, applied part part evice which its intend use
- necessarily comes into physical (bodily) contact with the patient that the device can fulfil its
function or
- can brought contact with the patient or
- needs touched the patient.
A lie part CF:
This applied part type which provides more significant protection against electric shock
than applied parts type compliance with the requirements defined IEC 601-1 and which
is marked follows:
08/ 2012 58
.
An insulated (unearthed) applied part described as:
an applied part which isolated from other parts the device such way that the current flowing
is not higher than the patient leakage current admissible for the firs lt, unintended voltage
from external source connected the patient and thus applied between the applied part
and earth.BENNING BENNING 750 A
and the protective contact the mains plug appliance plug the protective conductor connec
tion point the device respectively
E lectrical lian ce
Device (test sample) the condition which shall tested with regard electrical safety
19.2 Tech nical Term acco DIN 0751-1
A ctive part
Any part medical electrical device (except for the applied part) which can touched the
patient the operator touching the patient which might come into contact with the patient
D evice leakage current
Current flowing from mains supply units earth via accessible conductive parts the housing and
via applied parts
Fu ctio nnection
Any type connection (electrical other) including those used for transmission signals and/or
electric power and/or substances
Inspection
All measures taken determine and evaluate the actual condition the device
M edical electrical device
Electrical device which equipped with applied part, which serves transfer energy or
from the patient which indicates such energy transfer from the patient and for which the
following shall apply:
a) The device provided with not more than one connection certain power supply network and
b) intended for the following use its manufacturer:
1) diagnosis, treatment monitoring patient or
2) compensation palliation disease, injury disability
M edical electrical system
Combination individual devices defined the manufacturer among which least one must
be medical electrical device and which are connected means functional connection by
using multiple socket
P atie viro t
Any kind environment where connection can established intentionally unintentionally,
namely between patients and parts medical electrical device system between patient or
other perons touching parts the medical electrical device system
P atie leak rre t
Current flowing from the patient connections via the patient earth which caused unin
tended external voltage the patient and flows from the patient via the patient connections an
applied part type earth
C issioning
Initial use medical electrical device system after being installed the responsible organi
zation
R esp sib ization
Entity responsible for the use and maintenance medical electrical device system (can also
be person)
M aintenance
Any kind measures taken preserve the condition medical electrical device system in
compliance with the manufacturer's requirements
A lie parts
As introduction, the different types applied parts will described the following
