Codman Hakim Bedienungsanleitung Seite 21

Title of
Symbol
Symbol
Sterilized using
ethylene oxide
Do not
re-sterilize
Do not use
if package is
damaged
Non-Pyrogenic
Temperature
limit
Humidity
limitation
Atmospheric
pressure
limitation
Do not re-use
Prescription
Use Only
Made in
Distributed by Distributed by
Quantity
Medical Device
Magnetic
Resonance
(MR)
conditional
Manufacturer
Authorized
representative
in the European
Community
CE Mark
Meaning of
Symbol
Indicates a medical
device that has been
sterilized using
ethylene oxide
Indicates a medical
device that is not to
be resterilized
Indicates a medical
device that should
not be used if the
package has been
damaged or opened
Indicates a medical
device that is
non-pyrogenic
Indicates the
temperature limits
to which the medical
device can be safely
exposed
Indicates the range
of humidity to
which the medical
device can be safely
exposed
Indicates the range of
atmospheric pressure
to which the medical
device can be safely
exposed
Indicates a medical
device that is
intended for one
use, or for use on a
single patient during
a single procedure
Caution: Federal
(US) law restricts
this device to sale
by or on the order
of a physician or
licensed healthcare
practitioner
N/A
To indicate the
number of devices
per package
Indicates that the
product is classified
as a medical device
An Item with
demonstrated
safety in the MR
environment within
defined conditions
Indicates the medical
device manufacturer,
as defined in
EU Directives
90/385/EEC, 93/42/
EEC and 98/79/EC
Indicates the
authorized
representative in the
European Community
Product complies
with the
requirements of
directive 93/42/EEC
13
Reference
Standard
ISO 15223-1
Medical Devices –
Symbols to be
used with medical
device labels,
labelling and
information to be
supplied
Guidance
for Industry:
Alternative
to Certain
Prescription
Device Labeling
Requirements,
dated
January 21, 2000
Proprietary
N/A
ASTM F2503 –
Marking Medical
Devices and Other
Items for Safety in
the Magnetic
Resonance
Environment
ISO 15223-1
Medical Devices –
Symbols to be
used with medical
device labels,
labelling and
information to be
supplied
93/42/EEC
Number
5 2 3
5 2 6
M002
5 6 3
5 3 7
5 3 8
5 3 9
5 4 2
N/A
5 1 1
5 1 2
N/A