Symbols Commonly Used in Medical Device and Packaging Labeling

Symbols Commonly Used in Medical Device and Packaging Labeling

PAGE 1

No. Symbol Name Description Standard Clause 1. Rx only

Caution: Federal law restricts this device to sale by or on the order

Use of the “Rx only” symbol as an alternative to the prescription device labeling statement.

FDA Guidance Alternative to Certain Prescription Device Labeling Requirements

N/A

2.

Alarm to indicate an alarm on a control equipment

IEC 60601‐1‐8 Table C1, No. 1

3.

Alarm Reset To identify the control for ALARM RESET.

IEC 60601‐1‐8 Table C1, No. 2

4.

Alarm Off to identify the control for alarm off or to indicate the alarm off state;

standard Alarm (permanent) off icon

IEC 60601‐1‐8 Table C1, No. 3

5.

Alarm paused to identify the control for alarm paused or to indicate the alarm paused state;

standard Alarm (timed) off icon

IEC 60601‐1‐8 Table C1, No. 4

6.

Audio Off To identify the control

for AUDIO OFF or to indicate that the ALARM SYSTEM is in the AUDIO OFF state.

IEC 60601‐1‐8 Table C1, No. 5

7.

Audio paused To identify the control for AUDIO PAUSED or to indicate that the ALARM SYSTEM is in the AUDIO PAUSED state.

IEC 60601‐1‐8 Table C1, No. 6

8.

Acknow- ledged

On medical ALARM SYSTEMS this graphical symbol is used as follows: ACKNOWLEDGED

To identify the control for ACKNOWLEDGED.

IEC 60601‐1‐8 Table C1, No. 7

9.

or

Acknow- ledgement Bell cancel

To indicate that an ALARM CONDITION is in the ACKNOWLEDGED

IEC 60601‐1‐8 Table C1, No. 8


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No. Symbol Name Description Standard Clause

state for an indefinite period

10.

or

Acknow- ledgement Bell cancel

To identify the control whereby a bell may be switched off or to indicate the operating status of the bell.

IEC 60601‐1‐8 Table C1, No. 9

11.

Limits, general

To identify the control to display or set ALARM LIMITS.

IEC 60601‐1‐8 Table C1, No. 10

12.

Adjustable upper limit

To identify the control to display or set upper ALARM LIMIT.

IEC 60601‐1‐8 Table C1, No. 11

13.

Lower ALARM LIMIT

To identify the control to display or set the lower ALARM LIMIT.

IEC 60601‐1‐8 Table C1, No. 12

14.

Audio On (Bell)

To identify switches or indicate active audio e.g. a bell, acoustic alarm system.

IEC 60417‐1 5013

15.

Standby to identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition.

IEC 60417‐1 5009

16.

Battery check/ capacity

to identify a control to check the condition of a primary or secondary battery or to identify the battery condition indicator; important when device is in transport

IEC 60417‐1 5546

17.

0%

18.

25%

19.

50%

20. 75%

21.

100%

22.

Alternating Current

To indicate the type of mains supply

IEC 60601‐1 Table D.1 No.1


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No. Symbol Name Description Standard Clause 23.

Three Phase alternating current



24.

Three Phase alternating current with neutral conductor



25.

Direct Current To indicate the type of mains supply


26.

Both direct and alternating current



27.

Protective earth (ground)

To identify any terminal which is intended for connection to an external conductor for protection against electric shock in case of a fault, or the terminal of a protective earth (ground) electrode.


28.

Earth (ground) To identify an earth (ground) terminal


29.

Equipotentiality (equipotential ground)

To identify the terminals which, when connected together,

bring the various parts of an equipment or of a system to the same potential


30.

Class II equipment

To identify equipment meeting the safety requirements specified for Class II equipment


31.

Caution! Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.



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Operating instructions/ Instructions for use

Indicates the need for the user to consult the instructions for use.


33.

“On” Power To indicate connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved.


34.

“Off” Power To indicate disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.


35.

“On” / “OFF” (push-push)

To indicate connection to or disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.[]Each position, "ON" or "OFF", is a stable position.


36.

“On” / “OFF” (push button)

To indicate connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved. "OFF" is a stable position, whilst the "ON" position only remains during the time the button is depressed.


37.

“On” for part of equipment

To indicate the "ON" condition for a part of equipment, if the symbol 5007 (No. 33) cannot be used, for example, to identify the "ON" position of a switch.


38.

“Off” for part of equipment

To indicate the "OFF" condition for a part of equipment, if the symbol 5008 (No.34) cannot be used, for example, to



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No. Symbol Name Description Standard Clause identify the "OFF" position of a switch.

39.

Emergency stop

To identify an emergency stop control device.


40.

Type B applied part

To identify a type B applied part complying with, IEC 60601-1. Classification of protection against electrical shock.


41.

Type BF applied part

To identify a type BF applied part complying with IEC 60601-1. Classification of protection against electrical shock.


42.

Type CF applied part

To identify a type CF applied part complying with IEC 60601-1. Classification of protection against electrical shock.


43.

Category AP equipment

To identify category AP equipment complying with IEC 60601-1 which also specifies the way in which this symbol has to be used.


44.

Category APG equipment

To identify category APG equipment complying with IEC 60601-1 which also specifies the way in which this symbol has to be used.


45.

Dangerous voltage

To indicate hazards arising from dangerous voltages.


46.

Defibrillation-proof Type B applied part

To identify a defibrillation-proof type B applied part complying with IEC 60601-1.


47.

Defibrillation-proof Type BF applied part

To identify a defibrillation-proof type BF applied part



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No. Symbol Name Description Standard Clause complying with IEC 60601-1.

48.

Defibrillation-proof Type CF applied part

To identify a defibrillation-proof type CF applied part complying with IEC 60601-1.


49.

Stand‐by To identify the switch or switch position by means of which part of the equipment is switched on in order to bring it into the stand-by condition, and to identify the control to shift to or to indicate the state of low power consumption. Each of different states of power consumption may be indicated using a corresponding colour.


50.

General warning

General warning sign IEC 60601‐1 Table D.2 No.2

51.

Dangerous voltage

Warning sign, dangerous voltage


52.

General prohibition

General prohibition sign IEC 60601‐1 Table D.2 No.4

53.

No pushing Pushing prohibited IEC 60601‐1 Table D.2 No.5

54.

No sitting Sitting prohibited on marked item


55.

No stepping on surface

No stepping on surface


56.

General mandatory action

General mandatory action sign



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Follow instructions for use

Mandatory action sign, to read the instructions for use


58.

Neutral conductor connection

Connection point for the neutral conductor on permanently installed equipment


59.

IP Protection

IP Protection N1 = 0 Non-protected 1 Protected against solid objects of 50 mm Ø and greater 2 Protected against solid objects of 12.5 mm Ø and greater 3 Protected against solid objects of 2.5 mm Ø and greater 4 Protected against solid objects of 1.0 mm Ø and greater 5 Dust-protected 6 Dust-tight N2 = 0 Non-protected 1 Protection against vertically falling drops 2 Protection against vertically falling drops when enclosure tilt up to 15° 3 Protection against spraying water 4 Protection against splashing water 5 Protection against water jets 6 Protection against powerful water jets 7 Protected against the effects of temporary immersion in water 8 Protected against the effects of continuous immersion in water


60.

Manufacturer Indicates the medical device manufacturer, as defined in EU Directive 93/42/EEC

ISO 15223‐1 5.1.1

61.

Authorized representative

Indicates the authorized representative in the European Community.

ISO 15223‐1 5.1.2

62.

Date of manufacture

Indicates the date when the medical device was manufactured. includes at least a 4-digit year, followed by a 2-digit month and a 2-digit day, (YYYY-MM-DD)

ISO 15223‐1 5.1.3


PAGE 8


2014‐12‐31

Use by: Indicates the date after

which the medical device is not to be used.

(format date, YYYY-MM-DD)

ISO 15223‐1 5.1.4

64.

Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO 15223‐1 5.1.5

65.

followed by:

Catalogue number

Indicates the manufacturer’s catalogue number with Revision index so that the medical device can be identified.

ISO 15223‐1 5.1.6

66.

Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified.

ISO 15223‐1 5.1.7

67.

Sterilized usingaseptic processing techniques

Indicates a medical device that has been manufactured using accepted aseptic techniques.

ISO 15223‐1 5.2.2

68.

Sterilized usingethylene oxide

Indicates a medical device that has been sterilized using ethylene oxide.

ISO 15223‐1 5.2.3

69.

Sterilized usingirradiation

Indicates a medical device that has been sterilized using irradiation.

ISO 15223‐1 5.2.4

70.

Sterilized using steam or dry heat

Indicates a medical device that has been sterilized using steam or dry heat.

ISO 15223‐1 5.2.5

71.

Do not resterilize

Indicates a medical device that is not to be resterilized.

ISO 15223‐1 5.2.6

72.

Non-sterile Indicates a medical device that has not been subjected to a sterilization process.

ISO 15223‐1 5.2.7


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Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damaged or opened.

ISO 15223‐1 5.2.8

74.

Sterile fluid path

Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.

ISO 15223‐1 5.2.9

75.

Fragile, handle with care

Indicates a medical device that can be broken or damaged if not handled carefully.

ISO 15223‐1 5.3.1

76.

Keep away from sunlight

Indicates a medical device that needs protection from light sources.

ISO 15223‐1 5.3.2

77. Protect from heat and radioactive sources

Indicates a medical device that needs protection from heat and radioactive sources.

ISO 15223‐1 5.3.3

78.

Keep dry/ Keep away from rain

Indicates a medical device that needs to be protected from moisture.

ISO 15223‐1 5.3.4

79.

Lower limit of temperature

Indicates the lower limit of temperature to which the medical device can be safely exposed.

ISO 15223‐1 5.3.5

80.

Upper limit of temperature

Indicates the upper limit of temperature to which the medical device can be safely exposed.

ISO 15223‐1 5.3.6

81.

Temperature limit

Indicates the temperature limits to which the medical device can be safely exposed.

ISO 15223‐1 5.3.7

82.

Humidity limitation (rel.)

Indicates the range of humidity to which the

ISO 15223‐1 5.3.8


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No. Symbol Name Description Standard Clause medical device can be safely exposed.

83.

Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

ISO 15223‐1 5.3.9

84.

Biological risks Indicates that there are potential biological risks associated with the medical device.

ISO 15223‐1 5.4.1

85.

Do not re-use To identify devices which cannot be reused, also as synonyms for “single use”, “single patient use” and “use only once”.

ISO 15223‐1 5.4.2

86.

Contains or presence of natural rubber latex

For products containing natural rubber latex, which may cause allergic reaction.

ISO 15223‐1 5.4.5

87.

Not made with natural rubber latex

To indicate, that product is not made with natural rubber latex

ISO 15223‐1 5.4.5 w Annex B2

88.

Contains sufficient for, or Sufficient for

Sufficient for The number of items that the contents of the pack is sufficient for shall appear adjacent to the symbol.

ISO 15223‐1

5.5.5

89.

For IVD performance evaluation only

Indicates an IVD device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use.

ISO 15223‐1

5.5.6

90.

In vitro diagnostic medical device

Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.

ISO 15223‐1

5.5.1

91.

Control Indicates a control material that is intended to verify the performance characteristics of another medical device.

ISO 15223‐1 5.5.2


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Negative control

Indicates a control material that is intended to verify the results in the expected negative range.

ISO 15223‐1 5.5.3

93.

Positive control Indicates a control material that is intended to verify the results in the expected positive range.

ISO 15223‐1 5.5.4

94.

Fluid path Indicates the presence of a fluid path.

ISO 15223‐1 5.6.2

95.

Sterile Fluid path

Indicates the presence of a sterile fluid path.

ISO 15223‐1 5.6.2 w clear text

96.

Sampling site Indicates a medical device or blood processing application that includes a system dedicated to the collection of samples of a given substance stored in the medical device or blood container.

ISO 15223‐1 5.6.1

97.

Non-pyrogenic Indicates a medical device that is non-pyrogenic.

ISO 15223‐1 5.6.3

98.

Drops per millilitre

Indicates the number of drops per millilitre.

ISO 15223‐1 5.6.4

99.

Liquid filter with pore size

Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size.

ISO 15223‐1 5.6.5

100.

One-way valve Indicates a medical device with a valve that allows flow in only one direction.

ISO 15223‐1 5.6.6

101.

Patient number Indicates a unique number associated with an individual patient.

ISO 15223‐1 5.7.1


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Electrostatic-sensitive devices

Packages containing electrostatic-sensitive devices, or to identify a device or connector that is sensitive to electrostatic discharge

IEC 60417‐1 5134

103.

Power plug/ Mains

To identify connecting means (e.g. plug or cord) to the power source (mains)

IEC 60417‐1 5534

104.

Lock to identify on a control that a function is locked or to show the locked status; locked

IEC 60417‐1 5569

105.

Unlock To identify on a control that a function is not locked or to show the unlocked status.

IEC 60417‐1 5570

106.

T 1.6AL, 12V

Fuse To identify fuse boxes or their location, marked with the type and rating

IEC 60417‐1 5016

107.

6V – 1.1 Ah

Battery, (Positioning of cell)

Battery, marked the type of battery, the capacity and mode of insertion on the battery / battery pack.

IEC 60417‐1 5002

108.

7.15 V – 10 W

Input (Power Supply)

Power Supply: To distinguish between inputs and outputs (if necessary), add this symbol to identify the input terminal

IEC 60417‐1 5034

109.

Upper alarm limit

label for upper alarm limit IEC 60878 5650

110.

Lower alarm limit

label for lower alarm limit IEC 60878 5651

111.

or

MR Safe an item that poses no known hazards in all MR environments.

ASTM F2503 Table 1


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MR Conditional

an item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use (field strength, spatial gradient, dB/dt (time rate of change of the magnetic field), radio frequency (RF) fields, and specific absorption rate (SAR)

ASTM F2503 Table 1

113.

MR Unsafe an item that is known to pose hazards in all MR environments

ASTM F2503 Table 1

114. Baby, or Neonatal patient

To identify equipment, connections on equipment or operating modes which are dedicated for babies, for example on medical equipment.

IEC 60878 No. 5667

115.

Flow direction of sensitive components

Arrow indicating the direction of the flow for FLOW-DIRECTION-SENSITIVE COMPONENTS (components or ACCESSORYs through which gas flow has to be in one direction only for proper functioning or PATIENT safety) that are OPERATOR-removable without the use of a TOOL.

ISO 80601‐2‐12

Cl. 201.7.2.101 g)

116.

Connection of passive devices only

Warn the user that a connector is suitable only for connection to passive devices; when part of the insulation coordination when configuring a Medical Electrical

IEC 60601‐1 Table D.2 No.4 and Table D.1 No.5


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No. Symbol Name Description Standard Clause System

117.

Call Service Call for maintenance ISO 7000 0717

118.

Nurse call To indicate a reference to a nurse or the nursing staff, e.g. on a call button.

IEC 60878 5668

119.

Handle oil and grease free

To indicate the product shall not come into contact with oil or grease

ISO 7000 0248

Standards:

IEC 60601-1:2005 A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance IEC 60601-1-8:2006 A1:2012 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied ASTM F2503-08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment1 ISO 80601-2-12.2011 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators IEC 60417-1:2000 Graphical symbols for use on equipment - Part 1: Overview and application IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice ISO 7000:2014 Graphical symbols for use on equipment FDA Guidance “Alternative to Certain Prescription Device Labeling Requirements” 2000

Symbols Commonly Used in Medical Device and Packaging Labeling

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