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SYMBOL GLOSSARY
Symbol Name
Designation
Number
Use Standard Description
Refer to
Instruction
Manual /
Booklet
ISO-7010
M002
IEC 60601-
1:2005
Indicates a MANDATORY action for the
user to consult the Instructions For Use
(IFU). Symbol must be blue.
Consult
Instructions For
Use (IFU)
1641
ISO 15223-
1:2012
Indicates the need for the user to consult
the Instructions For Use (IFU).
Not required in conjunction with the
Caution symbol, if applicable.
C
Caution
0434A /
0434B
ISO 15223-
1:2012
Indicates the need for the user to consult
the Instructions For Use (IFU) for
important cautionary information such as
warnings and precautions that cannot, for
a variety of reasons, be presented on the
device itself.
Non-sterile ISO 7000-2609
ISO 15223-
1:2012
To indicate that the device that is normally
provided sterile in the same or similar
packaging has not been sterilized.
Locked 5569 IEC 60878:2015
To identify on a control that a function is
locked or to show the locked status.
Unlocked 5570 IEC 60878:2015
To identify on a control that a function is
not locked or to show the unlocked status.
Lock 0018 N/A
To indicate the function of locking or
clamping two machine parts together,
or location of a machine element in a
xed position.
Unlock 0019 N/A
To indicate the function of releasing two
machine elements locked or clamped
together, or the releasing of a machine
element from a xed position.
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Temperature
Limitation
0632
ISO 15223-
1:2012
1
Indicates the temperature limits to which
the medical device can be safely exposed.
The upper and lower limits to temperature
shall be indicated adjacent to the upper
and lower horizontal lines.
Atmospheric
Pressure
Limitation
2621
ISO 15223-
1:2012
1
Indicates the range of atmospheric
pressure to which the medical device can
be safely exposed. The atmospheric
pressure limitations shall be indicated
adjacent to the upper and lower hori-
zontal lines.
Humidity
Limitation
2620
ISO 15223-
1:2012
1
Indicates the range of humidity to which
the medical device can be safely exposed.
The humidity limitations shall be
indicated adjacent to the upper and lower
horizontal lines.
Serial # 2498
ISO 15223-
1:2012
Indicates the manufacturer’s serial
number so that a specic medical device
can be identied.
Lot / Batch Code 2492
ISO 15223-
1:2012
Indicates the manufacturer’s batch code
so that the batch or lot can be identied.