Hologic Myosure REACH 10-401FC Instrucciones De Uso página 11

Symbols Glossary
Standard
Reference
Symbol
& Symbol
Number
EC REP
EN ISO 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
Directive 93/42/
EEC, Article 17
and Annex XII
European
Medical Device
Regulation
2017/745,
Annex V
EN ISO 15223-1,
5.4.3
ISO 7000, 1641
IEC 60601-1,
Table D.1, 11
ISO/DIS 15223-
1, 5.7.11
ISO 7000,
CC
6049
EN ISO 15223-1,
5.1.3
ISO 7000, 2497
BS EN 15986
Annex B
Title of
Description of Symbol
Symbol
Authorized
representative Indicates the Authorized
in the representative in the
European European Community.
Community
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 that the
number
medical device can be
identified.
To indicate that caution
is necessary when
operating the device or
control close to where
the symbol is placed,
Caution or to indicate that the
current situation needs
operator awareness or
operator action in order
to avoid undesirable
consequences.
Indicates the medical
device conforms to
European Medical
CE marking of
Directive 93/42/EEC and
conformity
meets applicable health,
with notified
safety, and environmental
body
requirements. If the mark
identification
is accompanied by a
number
number, conformity is
verified by the indicated
notified body.
Consult Indicates the need for
instructions for the user to consult the
use instructions for use.
Country of To identify the country of
manufacture manufacture of products.
Indicates the date when
Date of
the medical device was
manufacture
manufactured.
Does not
Indicates patient contact
contain the
parts do not contain the
presence
presence phthalates.
phthalates
MyoSure Tissue Removal System IFU
Standard
Reference
Symbol
& Symbol
Number
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,
5.2.8
ISO 7000,
2606
EN ISO 15223-1,
5.3.2
ISO 7000,
0624
ISO 780
EN ISO 15223-1,
5.3.4
ISO 7000,
0626
ISO 780
EN ISO 15223-
1, 5.1.1
ISO 7000,
3082
ISO/DIS 15223-
1, 5.7.7
ISO 7000, 2794
FDA 21 CFR 801
ISO/DIS 15223-
1, 5.7.11
ISO 7000, 3707
ISO/DIS 15223-
1, 5.7.14
ISO 7000, 3709
Title of
Description of Symbol
Symbol
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.
Indicates a medical
device that should not
be used if the package
Do not use
has been damaged or
if package is
opened and that the
damaged
user should consult the
instructions for use for
additional information.
Indicates a medical
Keep away device that needs
from heat protection from heat
sources.
Indicates a medical
Keep dry device that needs to be
protected from moisture.
Indicates the medical
Manufacturer
device manufacturer.
Medical Indicates the item is a
device medical device
To indicate the number of
Packaging unit
pieces in the package.
Caution: Federal law
Prescription restricts this device to
use only sale by or on the order of
a physician.
Single sterile Indicates a single sterile
barrier system barrier system.
Single sterile
Indicates a single sterile
barrier system
barrier system with
with protective
protective packaging
packaging
outside.
outside
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