Symbols Glossary - Hologic Fluent Pro Bedienungsanleitung

S G
YMBOLS LOSSARY
Standard
Reference &
Symbol
Symbol
Number
EN ISO 15223-
1, 5.1.5
ISO 7000, 2492
EN ISO 15223-
1, 5.1.6
ISO 7000, 2493
EN ISO 15223-
1, 5.4.3
ISO 7000, 1641
IEC 60601-1,
Table D.1, 11
EN ISO 15223-
1, 5.1.7
ISO 7000, 3082
ISO/DIS 15223-
1, 5.7.11.
ISO 7000, 6049
EN ISO 15223-
1, 5.1.3
ISO 7000, 2497
EN ISO 15223-
1, 5.1.4
ISO 7000-2607
EN 15986
4.2, Annex
A and
Annex B
ISO 7000-2725
EN ISO 15223-
1, 5.2.6
ISO 7000, 2608
EN ISO 15223-
1, 5.4.2
ISO 7000, 1051
IEC 60601-1,
Table D.1, 28
EN ISO 15223-
1 5.2.11
ISO 7000-2794
FDA 21 CFR
801
ISO/DIS 15223-
1, 5.7.7
ISO/DIS 15223-
1, 5.7.10.
Title of
Description of
Symbol
Symbol
Indicates the
manufacturer's batch
Batch code
code so that the batch
or lot can be identified.
Indicates the
manufacturer's
Catalogue
catalogue number so
number
that the medical device
can be identified.
Consult Indicates the need for
instructions for the user to consult the
use instructions for use.
Indicates the medical
Manufacturer
device manufacturer
To identify the country
of manufacture of
Country of
products
Manufacture
Indicates the date
Date of
when the medical
manufacture
device was
manufactured.
Indicates the date after
which the medical
Use-by date
device is not to be
used.
Does not
Indicates patient
contain
contact parts do not
contain the presence of
phthalates
phthalates.
(DEHP)
Indicates a medical
Do not
device that is not to be
resterilize
resterilized.
Indicates a medical
Do not re-use device that is intended
for one single use only.
Single sterile Indicates a single
barrier system sterile barrier system
To indicate the number
Packaging unit of pieces in the
package.
Caution: Federal law
restricts this device to
Prescription
sale by or on the order
use only
of a physician
Indicates the item is a
Medical
medical device.
device
Unique Device
Indicates a carrier that
Identifier contains Unique Device
Identifier information.
Standard
Reference &
Symbol
Symbol
Number
EN ISO 15223-
1, 5.2.8
ISO 7000-2606
EN ISO 15223-
1, 5.4.4
ISO 7000,
0434A
IEC 60601-1,
Table D.1, 10
EN ISO
15223-1
5.4.5 and
Annex B
ISO 7000-2725
European
Medical
Directive
93/42/EEC,
Article 17 and
Annex XII
European
Medical
Device
Regulation
2017/745,
Annex V
EN ISO
15223-1, 5.1.2
Hologic, Fluent, In-FloPak, Out-FloPak, MyoSure
and associated logos are registered trademarks of
Hologic, Inc. and/or its subsidiaries in the United
States and other countries. All other trademarks,
registered trademarks, and product names are the
property of their respective owners.
©2018-2025 Hologic, Inc.
Title of
Description of
Symbol
Symbol
Indicates that a medical
device that should not
be used if the package
Do not use if
has been damaged or
package is
opened and that the
damaged
user should consult the
instructions for use for
additional information
To indicate that caution
is necessary when
operating the device or
control close to where
the symbol is placed, or
Caution to indicate that the
current situation needs
operator awareness or
operator action in order
to avoid undesirable
consequences.
Indicates that natural
rubber latex was not
Product is not
used in the
made from
manufacturing of the
natural rubber
product,
latex
its container, or its
packaging.
Indicates the medical
device conforms to
European Medical
CE marking Directive 93/42/EEC
of conformity and meets applicable
with notified health, safety, and
body environmental
identification requirements. If the
number mark is accompanied
by a number,
conformity is verified
by the indicated
notified body.
Authorized
Indicates the
representativ
Authorized
e in the
representative in the
European
European Community.
Community
AW-34247-001, Rev. 002
06/2025
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