Beckman Coulter MicroScan Manuel D'utilisation page 7

Symbol
ISO 15223-1: Medical Devices - Symbols to be Used with Medical Device Labels, Labeling and Information
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or
registered trademarks of Beckman Coulter, Inc. in the United States and other countries.
C29879–AB
Symbol Title
Manufacturer
Date of Manufacture
Authorized Representative in the
European Community
Contains sufficient for <n> tests
In Vitro Diagnostic Medical
Device
Temperature Limitation
Consult Instructions for Use
CE Mark
Contents
Contents (package)
Contents (package)
Safety Data Sheet
Made in USA
For Export Use Only
Reconstitution Volume
Fragile, handle with care
This way up
to be Supplied. Part 1: General Requirements.
Symbols Key
Description of Standard
Indicates the medical device
manufacturer, as defined in
EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
Indicates the date when
the medical device was
manufactured.
Indicates the authorized
representative in the European
Community.
Indicates the total number of
IVD tests that can be performed
with the IVD. (Typically included
on reagent kits).
Indicates a medical device that
is intended to be used as an in
vitro diagnostic medical device.
Indicates the temperature limits
to which the medical device
can be safely exposed.
Indicates the need for the user
to consult the instructions
for use.
European Conformity
Regulatory Mark
n/a
Antimicrobial Agent
(abbreviation)
Identification Substrate
(abbreviation)
Indicates a safety data sheet. n/a
n/a
n/a
n/a
Indicates a medical device that
can be broken or damaged if
not handled carefully.
Indicates the correct upright
position
7 of 141
Standard
ISO 15223-1, clause 5.1.1
ISO 15223-1; 5.3.1
ISO 15223-1, clause 5.1.2
ISO 15223-1; 5.5.5
ISO 15223-1, clause 5.5.1
ISO 15223-1; 5.3.7
ISO 15223-1; 5.4.3
n/a
n/a
n/a
n/a
n/a
n/a
n/a
ISO 15223-1; 5.3.1
ISO 7000: 0623