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March 2022
Hazard Identification /
Warning Symbols
Manufacturer / Country of
Origin
Country Specific
Requirements
Designation /
Title of Symbol
Reference number
Magnetic field
None – Internal
strength
symbol
Warning: Pinch
None – Internal
point hazard
symbol
Designation /
Title of Symbol
Reference number
ISO 15223-1,
Symbol 5.1.1
Manufacturer
IEC 60878,
Symbol 3082
ISO 15223-1,
Symbol 5.1.3
Date and
country of
IEC 60878,
manufacture
Symbols 6049
ISO 3166-1
Designation /
Title of
Reference
Symbol
number
ISO 7000,
Importer
Symbol 3725
ISO 7000,
Distributor
Symbol 3724
Prescription
21 CFR Part
Device
801.109
Page 12
Reference Standards
None – Internal symbol
None – Internal symbol
Reference Standards
ISO 15223-1: Medical devices -
Symbols to be used with
medical device labels, labelling
and information to be supplied
- Part 1: General requirements
IEC 60878: Graphical symbols
for electrical equipment in
medical practice
ISO 15223-1: Medical
devices - Symbols to be
used with medical device
labels, labelling and
information to be supplied
- Part 1: General
requirements
IEC 60878: Graphical
symbols for electrical
equipment in medical
practice
Reference Standards
ISO 7000: Graphical
symbols for use on
equipment
ISO 7000: Graphical
symbols for use on
equipment
21 CFR Part 801.109
Prescription Devices
Description of Symbol
Indicates the magnetic field
strength and the appropriate
strength MR scanner (1.5T or
3.0T) that the medical device
is intended for use with.
Warns user of a closing
motion of mechanical parts
of equipment that may pinch
fingers.
Description of Symbol
Indicates the medical device
manufacturer.
Indicates the date when
the medical device was
manufactured. Country of
origin is represented by
the alpha-2 country code
("CC") defined in ISO
3166-1.
Description of Symbol
Identifies the entity
importing the medical
device into the locale.
Identifies the entity
distributing the medical
device into the locale.
Indicates: Prescription
Device
Caution: US Federal law
restricts this device to sale
by or on the order of a
clinician.
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