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Medical device Label requirements
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Minimum requirement to be on the Label:
On the label
Manufacturer
The date of manufacture, as well as the name and address of the manufacturer, can be
combined in one symbol.
Authorized representativein
the European Community
Date of manufacture
This symbol can be filled or unfilled. If filled, thedate of manufacture as well as the name
and address of the manufacturer can be combined in one symbol.
Use-by date Synonymfor “use-by date” is “useby.”
Batch code Synonyms for “batch code” are “lot number” and “batch number.”
Catalogue number Synonyms for “catalogue number” are “reference number” and “reorder number.”
Serial number
On the box/ carton
Do not use if package is
damaged
This symbol may also mean “Do not use if the product sterile barrier systemor its packaging
is compromised.”
Fragile, handle with care
Keep dry
Temperaturelimit
Humidity limitation
Caution
This symbol is essentially a cautionary symbol and should be used to highlight the fact that
there are specific warnings or precautions associated with the medical device, which are not
otherwise found on thelabel.
On the device
“ON”(power)
To indicate connection to the mains, at least for mains switches, or their positions, and
all thosecases where safety is involved.
IEC 60417-5007 (2002-10)
“OFF”(power)
To indicate disconnection from the mains, at least for main switches, or their positions,
and all those cases where safety is involved.
IEC 60417-5008 (2002-10)
“ON”/”OFF”(push-
push)
To indicate connection to or disconnection from the mains, at least for mains switches
or their positions, and all thosecases where safety is involved.
Each position, “ON”or “OFF”, is a stable position
IEC 60417-5010 (2002-10)
Alternating current
To indicate on the rating platethat the equipment is suitable for alternating current
only; to identify relevant terminals.
IEC 60417-5032 (2002-10)
Protective earth;
protectiveground
To identify any terminal which is intended for connection to an external conductor for
protection against electric shock in case of fault, or the terminal of a protectiveearth
(ground) electrode.
IEC 60417-5019 (2006-08)
Direct current
To indicate on the rating platethat the equipment is suitable for direct current only; to
identify relevant terminals.
IEC 60417-5031 (2002-10)
Television monitor To identify theterminals and controls for a television monitor. IEC 60417-5051 (2002-10)
Non-ionizing
electromagnetic
radiation
To indicate generally elevated, potentially hazardous, levels of non-ionizing radiation,
or to indicate equipment or systems, e.g. in themedical electrical area that include RF
transmitters or that intentionally apply RF electromagnetic energy for diagnosis or
treatment.
IEC 60417-5140 (2003-04)
Packaging unit
To indicate the number of pieces in the package.
Note – A number is inserted in the symbol to indicate the number of parts in the
package.
ISO 7000-2794 (2009-02)
Class II equipment
To identify equipment meetings thesafety requirements specified for Class II
equipment according to IEC 61140.
IEC 60417-5172 (2003-02)
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TypeCF applied part
To identify a typeCF part complyingwith IEC 60601-1.
Note 1 – C = Cardial.
Note 2 – F = Floating applied part.
IEC 60417-5335 (2002-10)
Locking, general To identify on a control that a function is locked or to show the locked status.
IEC 60417-5569
(2005-05)
Unlocking
To identify on a control that is a function is not locked or to show the unlocked
status.
IEC 60417-5570
(2002-10)
Computer network
To identify thecomputer network itself or to indicate the connecting terminals of
the computer network.
IEC 60417-5988
(2006-09)
Refer to instruction
manual/booklet
To signify that theinstruction manual/booklet must be read.
IEC 60601-1
(2005+A1:2012
General prohibition
sign
Templatefor constructing a prohibition sign.
Note - This safety sign cannot be used on its own and requires a supplementary
sign to give further information about the action which is prohibited.
ISO 3864-1 Fig. 1
Do not touch To prohibit touching objects/parts of an object.
General warning sign
To signify a general warning.
Note - This safety sign cannot be used on its own and requires a supplementary
sign to give further information about the hazard.
IEC TR 60878 note: On medical equipment, this safety sign shall only be used if
there is no other safety sign for the corresponding hazard. If possible, the
hazard or the appropriate precaution should be indicated.
Warning: electricity To warn of electricity.
Symbol Additional Information
IPX0 No protection of equipment against ingress of water with harmful side effects (non-protected).
IP21
Protection of equipment against ingress of solid foreign objects ≥ 12.5 mm diameter. Protection
against access to hazardous parts with a nger. Protection against vertically falling water drops when
equipment is tilted up to 15°.
IPX1 Protection against vertically falling water drops
Other Marks and Symbols
Symbol
Quantity
Stock Keeping
Unit
This symbol should be replaced with #2794 packaging unit when possibleA product
identification code.
Contact for
service
Based on ISO 7000:0717 (2004-01)
On/O (push/push)
Power
Based on IEC 60417-5009 (2002-10)
+ Increase
brightness
Based on symbol 5056 from IS EN 60417-1:2002. Graphical symbols for use on equipment.
Part 1: Overview and application (IEC 60417-1:2000)
Brightness; brilliance. To identify thebrightness control, for example of a light dimmer, a
television receiver, a monitor, an oscilloscope.
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−
Decrease
brightness
Based on symbol 5056 from IS EN 60417-1:2002. Graphical symbols for use on equipment.
Part 1: Overview and application (IEC 60417-1:2000)
Brightness; brilliance. To identify thebrightness control, for example of a light dimmer, a
television receiver, a monitor, an oscilloscope.