GE 5160986-2 - Page 12

Page 12
March 2022
Hazard Identification /
Warning Symbols
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Magnetic field
strength
None – Internal
symbol
None – Internal 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.
Warning: Pinch
point hazard
None – Internal
symbol
None – Internal symbol
Warns user of a closing
motion of mechanical parts
of equipment that may pinch
fingers.
Manufacturer / Country of
Origin
Title of Symbol
Designation /
Reference number
Reference Standards
Description of Symbol
Manufacturer
ISO 15223-1,
Symbol 5.1.1
IEC 60878,
Symbol 3082
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
Indicates the medical device
manufacturer.
Date and
country of
manufacture
ISO 15223-1,
Symbol 5.1.3
IEC 60878,
Symbols 6049
ISO 3166-1
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
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.
Country Specific
Requirements
Title of
Symbol
Designation /
Reference
number
Reference Standards
Description of Symbol
Importer
ISO 7000,
Symbol 3725
ISO 7000: Graphical
symbols for use on
equipment
Identifies the entity
importing the medical
device into the locale.
Distributor
ISO 7000,
Symbol 3724
ISO 7000: Graphical
symbols for use on
equipment
Identifies the entity
distributing the medical
device into the locale.
Prescription
Device
21 CFR Part
801.109
21 CFR Part 801.109
Prescription Devices
Indicates: Prescription
Device
Caution: US Federal law
restricts this device to sale
by or on the order of a
clinician.