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Glossary of Symbols
Standards
Symbol
Reference
Medical
-
Device
21 CFR Part
Rx Only
801.109(b)(1)
ISO 15223-1
Symbol 5.4.5
LATEX
(Reference Annex B
for the general
prohibition symbol)
-
ISO 15223-1
Symbol 5.1.1
ISO 15223-1
Symbol 5.1.3
ISO 15223-1
Symbol 5.1.5
ISO 15223-1
Symbol 5.1.6
ISO 15223-1
Symbol 5.4.3
ISO 60601-1
Table D.1 #11
ISO 15223-1
Symbol 5.4.3
natus.com
Annex A #A.15
ISO 60601-1
Table D.2 #10
ISO 15223-1
Symbol 5.4.4
ISO 60601-1
Table D.1 #10
ISO 15223-1
Symbol 5.1.4
ISO 15223-1
Symbol 5.2.8
ISO 15223-1
Symbol 5.3.7
Standard Title of Symbol
-
Labeling-Prescription devices.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
-
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical electrical equipment — Part 1:
General requirements for basic safety
and essential performance.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical electrical equipment — Part 1:
General requirements for basic safety
and essential performance.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical electrical equipment — Part 1:
General requirements for basic safety
and essential performance.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Medical devices — Symbols to be used
with medical device labels, labelling
and information to be supplied.
Symbol Title as per
Explanation
Reference Standard
An indication of
This product is a medical device.
Medical device
Prescription only
Indicates the product is authorized for sale
by or on the order of a licensed healthcare
practitioner.
Not made with
Indicates a medical device that is not made
Natural Rubber Latex
with natural rubber latex.
Quantity
Number of parts in a package.
Manufacturer
Indicates the medical device manufacturer.
Date of manufacture Indicates the date when the medical device
was manufactured.
Batch or Lot code
Indicates the manufacturer's batch code so
that the batch or lot can be identified.
Catalogue number
Indicates the manufacturer's catalogue
number so that the medical device can be
identified.
Consult instructions
Indicates the need for the user to consult
for use
the instructions for use.
Operating
instructions
Consult instructions
Indicates an instruction to consult an
for use
electronic instructions for use (eIFU).
Follow instructions
Refer to instruction manual/ Booklet.
for use
NOTE on ME EQUIPMENT "Follow
instructions for use"
Caution: Read
Indicates the need for the user to consult
all warnings and
the instructions for use for important
precautions in
cautionary information such as warnings
instructions for use
and precautions that cannot, for a variety
of reasons, be presented on the medical
device itself.
Use-by date
Indicates the date after which the medical
device is not to be used.
Note: This symbol shall be accompanied by
a date to indicate that the medical device
should not be used after the end of the
year, month or day shown.
Do not use if package
Indicates a medical device that should not
is damaged
be used if the package has been damaged
or opened.
Temperature limit
Indicates the (storage) temperature limits
to which the medical device can be safely
exposed.
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