MADSEN Alpha OAE+ Screener User Manual
9
Symbol
Standard Reference
Standard Title
Symbol Title
Explanation
ISO 15223-1
Symbol 5.1.6
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Catalogue number
Indicates the
manufacturer’s
catalogue number
so that the medical
device can be
identified.
ISO 15223-1 Symbol
5.1.7
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Serial number
Indicates the
manufacturer's
serial number so
that a specific
medical device can
be identified.
ISO 15223-1
Symbol 5.1.3
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Date of
manufacture
Indicates the date
when the medical
device was
manufactured.
ISO 15223-1
Symbol 5.1.1
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Manufacturer
Indicates the
medical device
manufacturer.
ISO 15223-1
Symbol 5.3.8
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Humidity limitation
Indicates the range
of (storage)
humidity to which
the medical device
can be safely
exposed.
ISO 15223-1
Symbol 5.3.9
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Atmospheric
pressure limitation
Indicates the
acceptable upper
and lower limits of
atmospheric
pressure for
transport and
storage.
ISO 15223-1
Symbol 5.3.7
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Temperature limit
Indicates the
(storage)
temperature limits
to which the
medical device can
be safely exposed.
IEC 60601-1
Table D.2 #2
Medical electrical equipment
— Part 1:
General requirements for basic safety
and Essential performance
General warning
sign
Indicates a hazard
of potential personal
injury to patient or
operator.
ISO 15223-1
Symbol 5.4.4
Medical devices
— Symbols to be used
with medical device labels, labelling and
information to be supplied
Caution
Indicates the need
for the user to
consult the
instructions for use
for important
cautionary
information such as
warnings and
precautions that
cannot, for a variety
of reasons, be
presented on the
medical device
itself.
IEC 60601-1
Table D.1 #10
Medical electrical equipment
— Part 1:
General requirements for basic safety
and essential performance
