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English
Symbols Glossary
Standard
Reference
Symbol
& Symbol
Number
EN ISO
EC
REP
15223-1,
5.1.2
EN ISO
15223-1,
5.1.5
ISO 7000,
2492
EN ISO
15223-1,
5.1.6
ISO 7000,
2493
EN ISO
15223-1,
5.4.4
ISO 7000,
0434A
IEC 60601-1,
Table D.1, 10
European
Medical Di-
rective 93/
42/EEC, Ar-
ticle 17 and
Annex
XII
EN ISO
15223-1,
5.4.3
ISO 7000,
1641
IEC 60601-1,
Table D.1, 11
ISO/DIS
15223-1,
5.7.11
CC
ISO 7000,
6049
EN ISO
15223-1,
5.1.3
ISO 7000,
2497
BS EN
15986
Annex B
EN ISO
15223-1, 5.1.1
ISO 7000,
3082
4
Title of
Description of Symbol
Symbol
Authorized
representa-
Indicates the Authorized
tive in the
representative in the Euro-
European
pean Community.
Community
Indicates the manufac-
turer's batch code so that
Batch code
the batch or lot can be
identified.
Indicates the manufac-
Catalogue
turer's catalogue number
number
so that the medical device
can be identified.
To indicate that caution is
necessary when operating
the device or control close
to where the symbol is
placed, or to indicate that
Caution
the current situation needs
operator awareness or
operator action in order to
avoid undesirable conse-
quences.
Indicates the medical de-
vice conforms to
European Medical Direc-
tive 93/42/EEC and meets
European
applicable health, safety,
Conformity
and environmental require-
ments. If the mark is ac-
companied by a number,
conformity is verified by
the indicated notified body.
Consult
Indicates the need for the
instructions
user to consult the instruc-
for use
tions for use.
Country of
To identify the country of
manufac-
manufacture of products.
ture
Date of
Indicates the date when
manufac-
the medical device was
ture
manufactured.
Does not
Indicates patient contact
contain the
parts do not contain the
presence
presence phthalates.
phthalates
Manufac-
Indicates the medical de-
turer
vice manufacturer.
Symbol
UDI
Hologic, Omni and associated logos are trademarks and/or
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.
©2023 Hologic, Inc.
Omni® Instrument Tray IFU
Standard
Reference
Title of
& Symbol
Symbol
Number
ISO/DIS
Medical
15223-1,
device
5.7.7
ISO 7000,
Packaging
2794
unit
ISO/DIS
Unique
15223-1,
Device
5.7.10
Identifier
Description of Symbol
Indicates the item is a
medical device
To indicate the number of
pieces in the package.
Indicates a carrier that con-
tains Unique Device Identi-
fier information
AW-28516-001 Rev. 001
07/2023
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