Symbol glossary definitions

STANDARD
SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY TEXT
REFERENCE

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Reference no. 5.1.1. labeling, and information to be Manufacturer Indicates the medical device manufacturer
(ISO 7000-3082) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

used with medical device labels,
ISO 15223- 1:2016
labeling, and information to be
Reference no. 5.1.2
supplied – Part 1: General
requirements.
Authorized
Indicates the authorized representative in the European Community /
Representative in the
European Union
European Community

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Reference no. 5.1.3. labeling, and information to be Date of manufacture Indicates the date when the medical device was manufactured
(ISO 7000-2497) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels, Indicates the date after which the medical device is not to be used
Use-by date
Reference no. 5.1.4. labeling, and information to be iso_15223 Use-by date
Use by date
(ISO 7000-2607) supplied – Part 1: General iso_grs_7000_2607 Use by date
requirements.
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SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY TEXT
REFERENCE

Medical devices — Symbols to be Batch code

ISO 15223- 1:2016 used with medical device labels,
Indicates the manufacturer's batch code so that the batch or lot can be
Reference no. 5.1.5. labeling, and information to be
identified
(ISO 7000-2492) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

Indicates the manufacturer's catalog number so that the medical
ISO 15223- 1:2016 used with medical device labels,
Catalogue number device can be identified
Reference no. 5.1.6. labeling, and information to be
Catalog number ISO 15223 Catalogue number
(ISO 7000-2493) supplied – Part 1: General
ISO 7000 Catalog number
requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Indicates the manufacturer's serial number so that a specific medical
Reference no. 5.1.7. labeling, and information to be Serial number
device can be identified
(ISO 7000-2498) supplied – Part 1: General
requirements.

ISO 15223- Medical devices — Symbols to be

1:2020(E) DRAFT used with medical device labels,
Country of manufacture To identify the country of manufacture of products
Reference no. 5.1.11. labeling and information to be
(ISO 7000- 6049) supplied

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Indicates a medical device that has been subjected to a sterilization
Reference no. 5.2.1. labeling, and information to be Sterile
process
(ISO 7000-2499) supplied – Part 1: General
requirements.
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REFERENCE

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Sterilized using aseptic Indicates a medical device that has been manufactured using accepted
Reference no. 5.2.2. labeling, and information to be
processing techniques aseptic techniques
(ISO 7000-2500) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

ISO 15223-1:2016 used with medical device labels,
Sterilized using ethylene Indicates a medical device that has been sterilized using ethylene
Reference no. 5.2.4. labeling, and information to be
oxide oxide.
(ISO 7000-2501) supplied – Part 1: General
requirements.

Medical devices — Symbols to be Indicates a medical device that has been sterilized using irradiation
ISO 15223-1:2016 used with medical device labels,
Sterilized using
Reference no. 5.2.4. labeling, and information to be
irradiation
(ISO 7000-2502) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

used with medical device labels,
ISO 7000-2503 Sterilized using steam or To indicate that the device is provided sterile and has been sterilized
labeling, and information to be
Reference no. 2503 dry heat using steam or dry heat
supplied – Part 1: General
requirements.

Medical devices — Symbols to be Do not resterilize Indicates a medical device that is not to be resterilized
ISO 15223-1:2016 used with medical device
Reference no. 5.2.6. labels, labeling, and information to
(ISO 7000- 2608) be supplied – Part 1: General
requirements.
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SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY TEXT
REFERENCE

Medical devices — Symbols to be Non-sterile

ISO 15223- 1:2016 used with medical device labels,
Indicates a medical device that has not been subjected to a
Reference no. 5.2.7. labeling, and information to be
sterilization process
(ISO 7000-2609) supplied – Part 1: General
requirements.

Medical devices — Symbols to be Sterile fluid path

ISO 15223- 1:2016 used with medical device labels, Indicates the presence of a sterile fluid path within the medical device
Reference no. 5.2.9. labeling, and information to be in cases when other parts of the medical device, including the
(ISO 7000-3084) supplied – Part 1: General exterior, might not be supplied sterile
requirements.

Medical devices — Symbols to be Sterile fluid path A.12 Examples of use of symbol 5.2.9 for “Sterile fluid path”
ISO 15223- 1:2016 used with medical device labels,
Reference no. A.12, labeling, and information to be
NOTE 1 supplied – Part 1: General
requirements.

Medical devices — Symbols to be Sterile fluid path A.12 Examples of use of symbol 5.2.9 for “Sterile fluid path”
ISO 15223- 1:2016 used with medical device labels,
Reference no. A.12, labeling, and information to be
NOTE 2 supplied – Part 1: General
requirements.

Medical devices — Symbols to be Fragile, handle with care

ISO 15223- 1:2016 used with medical device labels,
Indicates a medical device that can be broken or damaged if not
Reference no. 5.3.1. labeling, and information to be
handled carefully
(ISO 7000-0621) supplied – Part 1: General
requirements.
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REFERENCE

Medical devices — Symbols to be Indicates a medical device that needs protection from light sources
ISO 15223- 1:2016 used with medical device labels,
Keep away from
Reference no. 5.3.2. labeling, and information to be
sunlight
(ISO 7000-0624) supplied – Part 1: General
requirements.

ISO 15223- 1:2016 Medical devices — Symbols to be

and ISO 15223- used with medical device labels, Indicates a medical device that needs protection from moisture
Keep dry
1:2020(E) DRAFT labeling, and information to be ISO 15223 Keep dry
Keep away from rain
Reference no. 5.3.4. supplied – Part 1: General ISO 7000 Keep away from rain
(ISO 7000-0626) requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Lower limit of Indicates the lower limit of temperature to which the medical device
Reference no. 5.3.5. labeling, and information to be
temperature can be safely exposed
(ISO 7000-0534) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Upper limit of Indicates the upper limit of temperature to which the medical device
Reference no. 5.3.6. labeling, and information to be
temperature can be safely exposed
(ISO 7000-0533) supplied – Part 1: General
requirements.

Medical devices — Symbols to be Temperature limit

ISO 15223- 1:2016 used with medical device labels,
Indicates the temperature limits to which the medical device can be
Reference no. 5.3.7. labeling, and information to be
safely exposed
(ISO 7000-0632) supplied – Part 1: General
requirements.
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REFERENCE

Medical devices — Symbols to be Humidity limitation

ISO 15223- 1:2016 used with medical device labels,
Indicates the range of humidity t which the medical device can be
Reference no. 5.3.8. labeling, and information to be
safely exposed
(ISO 7000-2620) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

ISO Atmospheric pressure To indicate the acceptable upper and lower limits of atmospheric
used with medical device labels,
15223- 1:2016 limitation pressure for transport and storage.
labeling, and information to be
Reference no. 5.3.9 Atmospheric Pressure ISO 15223 Atmospheric pressure limitation
supplied – Part
(ISO 7000-2621) limitation ISO 7000 Atmospheric Pressure limitation
1: General requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels, Indicates a medical device that should not be used if the package has
Do not use if package is
Reference no. 5.2.8. labeling, and information to be been damaged or opened and that the user should consult the
damaged
(ISO 7000-2606) supplied – Part 1: General instructions for use for additional information
requirements.

Medical devices — Symbols to be Biological risks

1:2016
used with medical device labels, To indicate a reference to substances that may be hazardous to men,
ISO 15223-1
labeling, and information to be animals, plants, or the environment based on biological activity (for
Reference no. 5.4.1.
supplied – Part 1: General example, holding a virus)
(ISO 7000-0659)
requirements.

Medical devices — Symbols to be Do not re-use

ISO 15223-1:2016E used with medical device Indicates a medical device that is intended for one single use only
Reference no. 5.4.2. labels, labeling, and information to NOTE: Synonyms for “Do not reuse” are “single use” and “use only
(ISO 7000- 1051) be supplied – Part 1: General once”.
requirements.
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REFERENCE

ISO 15223-1:2016
and ISO 15223- Medical devices — Symbols to be
Consult instructions for
1:2020 Reference no. used with medical device labels, Indicates the need for the user to consult the instructions for use
use
5.4.3. (ISO 7000- labeling, and information to be iso_15223 Consult instructions for use
Operator's manual;
1641) supplied – Part 1: General iso_grs_7000_1641 Operator's manual; operating instructions
operating instructions
Reference no. 5.4.3. requirements.
(ISO 7000-1641)

Medical devices — Symbols to be

used with medical device labels, Consult instructions for Indicates consult instructions for
ISO 15223-1:2016
labeling, and information to be use or consult electronic use for an electronic instruction for
Reference no. A.15
supplied – Part 1: General instructions for use use (eIFU)
requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Reference no. 5.4.4. labeling, and information to be
(ISO 7000-0434A) supplied – Part 1: General
requirements.
To indicate that caution is necessary when operating the device or
control close to where the symbol is placed, or to indicate that the
Caution
current situation needs operator awareness or operator action in order
to avoid undesirable consequences

Medical devices — Symbols to be

iso_grs_7010_WOO1 used with medical device labels,
labeling, and information to be General warning sign To signify a general warning
supplied – Part 1: General
requirements.

ISO 15223- 1:2016 Medical devices — Symbols to be Contains or presence of Indicates the presence of dry natural rubber or natural rubber latex as
Reference no. 5.4.5. used with medical device labels, natural rubber latex a material of construction within the medical device or the packaging
(ISO 7000, symbol labeling, and information to be of a medical device
2025) supplied – Part 1: General
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REFERENCE

requirements.

Medical Devices — Symbols to be Contains human blood Indicates a medical device contains or incorporates human blood
ISO/DIS 15223- used with medical device labels, or plasma derivatives products or plasma derivatives
1:2020(E) DRAFT labeling, and information to be
Reference no. 5.4.6 supplied — Part 1: General
(ISO 7000-3701) requirements. (Draft of New
Version)

Medical Devices — Symbols to be Contains a medicinal Indicates a medical device that contains or incorporates a medicinal
ISO/DIS 15223- used with medical device labels, substance substance
1:2020(E) DRAFT labeling, and information to be
Reference no. 5.4.7. supplied — Part 1: General
(ISO 7000-3702) requirements. (Draft of New
Version)

Medical Devices — Symbols to be Contains biological Indicates a medical device that contains biological tissue, cells, or
ISO/DIS 15223- used with medical device labels, material of animal origin their derivatives, of animal origin
1:2020(E) DRAFT labeling, and information to be
Reference no. 5.4.8. supplied — Part 1: General
(ISO 7000-3699) requirements. (Draft of New
Version)

Medical Devices — Symbols to be Contains biological Indicates a medical device that contains biological tissue, cells, or
ISO/DIS 15223- used with medical device labels, material of human origin their derivatives, of human origin
1:2020(E) DRAFT labeling, and information to be
Reference no. 5.4.9. supplied — Part 1: General
(ISO 7000-3700) requirements. (Draft of New
Version)
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SYMBOL STANDARD TITLE SYMBOL TITLE EXPLANATORY TEXT
REFERENCE

Medical Devices — Symbols to be

ISO/DIS 15223- used with medical device labels,
1:2020(E) DRAFT labeling, and information to be
Reference no. 5.4.10. supplied — Part 1: General
(ISO 7000-3723) requirements. (Draft of New
Version)
Indicates a medical device that contains substances that can be
Contains hazardous
carcinogenic, mutagenic, reprotoxic (CMR), or substances with
substances
endocrine-disrupting properties

Medical Devices — Symbols to be

ISO/DIS 15223- used with medical device labels,
1:2020(E) DRAFT labeling, and information to be Single patient-multiple Indicates a medical device that may be used multiple times (multiple
Reference no. 5.4.12. supplied — Part 1: General use procedures) on a single patient
(ISO 7000-3706) requirements. (Draft of New
Version)

Medical devices — Symbols to be

ISO 15223-1:2016
used with medical device labels,
and ISO 15223- In vitro diagnostic Indicates a medical device that is intended to be used as an in vitro
labeling, and information to be
1:2020(E) medical device diagnostic medical device
supplied – Part 1: General
Reference no. 5.5.1.
requirements.

Medical devices — Symbols to be

used with medical device labels,
ISO 15223- 1:2016 Indicates a control material that is intended to verify the performance
labeling, and information to be Control
Reference no. 5.5.2. of another medical device
supplied – Part 1: General
requirements.

ISO 15223- 1:2016 Medical devices — Symbols to be Negative control Indicates a control material that is intended to verify the results in the
Reference no. 5.5.3. used with medical device labels, expected negative range
(ISO 7000-2495) labeling, and information to be
supplied – Part 1: General
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REFERENCE

requirements.

Medical devices — Symbols to be Positive control

ISO 15223- 1:2016 used with medical device labels,
Indicates a control material that is intended to verify the results in the
Reference no. 5.5.4. labeling, and information to be
expected positive range
(ISO 7000-2496) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels,
Contains sufficient for Indicates the total number of IVD tests that can be performed with the
Reference no. 5.5.5. labeling, and information to be
<n> tests IVD medical device.
(ISO 7000-0518) supplied – Part 1: General
requirements.

Medical devices — Symbols to be

ISO 15223- 1:2016 used with medical device labels, Indicates an IVD device that is intended to be used only for
For IVD performance
Reference no. 5.5.6. labeling, and information to be evaluating its performance characteristics before it is placed on the
evaluation only
(ISO 7000-3083) supplied – Part 1: General market for medical diagnostic use
requirements.

Medical devices — Symbols to be Fluid path Indicates the presence of a fluid path
ISO 15223- 1:2016 used with medical device labels,
Reference no. 5.6.2. labeling, and information to be
(ISO 7000-2722) supplied – Part 1: General
requirements.

ISO 15223- 1:2016 Medical devices — Symbols to be Non-pyrogenic Indicates a medical device that is non-pyrogenic
Reference no. 5.6.3. used with medical device labels,
(ISO 7000-2724) labeling, and information to be
supplied – Part 1: General
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REFERENCE

requirements.

ISO 7000 Graphic symbols for use on Non-pyrogenic fluid

On medical devices: to indicate that the fluid path is non-pyrogenic
Reference no. 2723 electrical equipment path

Medical devices — Symbols to be On medical devices: to indicate the number of drops per milliliter.
ISO 15223-1:2016 used with medical device labels, That means the design of the drip tube in the drip chamber of the
Drops per milliliter
Reference no. 5.6.4. labeling, and information to be system.
Drops per millilitre
(ISO 7000-2726) supplied – Part 1: General iso_grs_7000_2726 Drops per milliliter
requirements. iso_154223 Drops per millilitre

Medical devices — Symbols to be

Indicates an infusion or transfusion
ISO 15223- 1:2016 used with medical device labels,
Liquid filter with pore system of the medical device that
Reference no. 5.6.5. labeling, and information to be
size contains a filter of a particular
(ISO 7000-2727) supplied – Part 1: General
nominal pore size
requirements.

Medical devices — Symbols to be Patient number Indicates a unique number associated with an individual patient
ISO 15223- 1:2016 used with medical device labels,
Reference no. 5.7.1. labeling, and information to be
(ISO 7000-2610) supplied – Part 1: General
requirements.

Medical Devices — Symbols to be Patient identification Indicates the identification data of the patient
ISO/DIS 15223-
used with medical device labels,
1:2020(E) DRAFT
labeling, and information to be
Reference no. 5.7.3
supplied — Part 1: General
(ISO 7000-5664)
requirements.
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REFERENCE

Medical Devices — Symbols to be

ISO/DIS 15223- used with medical device labels,
1:2020(E) DRAFT labeling, and information to be Patient information Indicates a website where a patient may obtain additional information
Reference no. 5.7.4 supplied — Part 1: General website on the medical product
(ISO 7000-3705) requirements. (Draft of New
Version)

ISO/DIS 15223- Medical devices — Symbols to be

1:2020(E) DRAFT used with medical device labels,
Health care center or To indicate the address of the health care center or doctor where
Reference no. 5.7.5. labeling, and information to be
doctor medical information about the patient may be found
(ISO 7001-PI PF supplied — Part 1: General
044) requirements.

Medical Devices — Symbols to be

ISO/DIS 15223- used with medical device labels,
1:2020(E) DRAFT labeling, and information to be To identify the date that information was entered, or a medical
Date
Reference no. 5.7.6 supplied — Part 1: General procedure took place
(ISO 7000-5662) requirements. (Draft of New
Version)

Medical Devices — Symbols to be

used with medical device labels,
ISO/DIS 15223-
labeling, and information to be
1:2020(E) DRAFT Medical device Indicates the item is a medical device
supplied — Part 1: General
Reference no. 5.7.7
requirements. (Draft of New
Version)
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REFERENCE

Medical devices — Symbols to be

ISO 15223-1:2020(E)
used with medical device labels, To identify that the original medical device information has
DRAFT
labeling, and information to be Translation undergone a translation which supplements or replaces the original
Reference no. 5.7.8.
supplied — Part 1: General information
(ISO 7000-3728)
requirements.

Medical devices — Symbols to be

ISO 15223-1:2020(E)
used with medical device labels,
DRAFT To identify that a modification to the original medical device
labeling, and information to be Repackaging
Reference no. 5.7.9. packaging configuration has occurred
supplied — Part 1: General
(ISO 7000-3727)
requirements.

IEC 60601- 1 Medical electrical equipment — To indicate on the rating plate

Reference no. Table Part 1: General requirements. for that the equipment is suitable for
Alternating current
D1, Symbol 8 (IEC basic safety and essential alternating current only; to identify
60417-5032) performance relevant terminals

IEC 60601-1 Medical electrical equipment —

Reference no. Table Part 1: General requirements. for To indicate on the rating plate that the equipment is suitable for direct
Direct current
D.1, Symbol 4 (IEC basic safety and essential current only; to identify relevant terminals
60417- 5031) performance

IEC 60601-1 Medical electrical equipment —

To identify any terminal which is intended for connection to an
Reference no. Table Part 1: General requirements. for Protective earth;
external conductor for protection against electric shock in case of a
D.1, Symbol 6 (IEC basic safety and essential protective ground
fault, or the terminal of a protective earth (ground) electrode
60417- 5019) performance.
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REFERENCE

To identify the terminals which, when

ICE 60601- 1 Medical electrical equipment — connected together, bring the various
Reference no. Table Part 1: General requirements. for parts of equipment or of a system
Equipotentiality
D1, Symbol 8 (IEC basic safety and essential to the same potential, not necessarily
60417-5021) performance being the earth (ground) potential,
e.g. for local bonding

IEC 60417
Reference no. Table Graphic symbols for use on To identify equipment meeting the safety requirements specified for
Class II equipment
D.1, Symbol 9 (IEC electrical equipment Class II equipment according to IEC 61140
60417- 5172)

IEC 60601-1, Medical electrical equipment —

Reference no. Table Part 1: General requirements. for TYPE B APPLIED
N/A
D.1, Symbol 19 (ICE basic safety and essential PART
60417-5480) performance

IEC 60601-1, Medical electrical equipment —

Reference no. Table Part 1: General requirements. for TYPE BF APPLIED
To identify a type BF applied part complying with IEC 60601-1
D.2, Symbol 20 (ICE basic safety and essential PART
60417-5333) performance

IEC 60601-1 Medical electrical equipment —

Reference no. Table Part 1: General requirements. for
Type CF applied part. To identify a type CF applied part complying with IEC 60601-1
D.1, Symbol 21 (IEC basic safety and essential
60417-5335) performance.
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IEC 60601-1 Medical electrical equipment —

Reference no. Table Part 1: General requirements. for Defibrillation-proof To identify a defibrillation-proof type BF applied part complying with
D.1, Symbol 26 (IEC basic safety and essential Type BF applied part IEC 60601-1
60417-5334) performance.

IEC 60601-1 Medical electrical equipment —

Reference no. Table Part 1: General requirements. for Defibrillation-proof To identify a defibrillation-proof Type CF applied part complying
D.1, Symbol 21 (IEC basic safety and essential Type CF applied part with IEC 60601-1
60417-5336) performance.

IEC 60601-1
Medical electrical equipment —
Database Reference
Part 1: General requirements. for
no. Table D2, Safety No pushing To prohibit pushing against an object
basic safety and essential
sign 5  (ISO 7010-
performance.
P017)

EC 60601-1, Medical electrical equipment —

Reference no. Table Part 1: General requirements. for Refer to instruction
To signify that the instruction manual/booklet must be read
D.2, Safety sign 10 basic safety and essential manual/booklet
(ISO 7010-M002) performance

IEC 60601-1 (IEC Medical electrical equipment – Part Degree of protection N1 = 0 Non-protected; 1 Protected against solid foreign objects of 50
60529) Table D.3; 1:General requirements. for basic mm Ø and greater; 2 Protected against solid foreign objects of 12,5
Code 2 6.3; Table safety and essential performance mm Ø and greater; 3 Protected against solid foreign objects of 2,5
D.3; Code 2 mm Ø and greater; 4 Protected against solid foreign objects of 1,0
mm Ø and greater; 5 Dust-protected; 6 Dust-tight N2 = 0 Non-
protected; 1 Protection against vertically falling water drops; 2
Protection against vertically falling water drops when ENCLOSURE
tilted up to 15°; 3 Protected against spraying water; 4 Protected
against splashing water; 5 Protected against water jets; 6 Protected
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REFERENCE

against powerful water jets; 7 Protected against the effects of

temporary immersion in water; 8 Protected against the effects of
continuous immersion in water

IEC 60601-1, (IEC

Medical electrical equipment – Part IP22: N1=2, Protected against solid foreign objects of 12,5 mm Ø and
60529) Reference no.
1:General requirements. for basic Degree of protection greater; N2=2, Protection against vertically falling water drops when
6.3; Table D.3, Code
safety and essential performance ENCLOSURE tilted up to 15°
2

IEC 60601-1, (IEC

60529) Reference no.
Medical electrical equipment – Part IP27: N1=2, Protected against solid foreign objects of 12,5 mm Ø and
6.3; Table D.3, Code
1:General requirements. for basic Degree of protection greater; N2=7, Protected against the effects of temporary immersion
2 (Refer to IEC
safety and essential performance in water
60529; see 7.2.9 and
11.6.5)

IEC 60601-1 (IEC

60529) Reference no. Medical electrical equipment – Part
6.3; Table D.3; Code IPX1: N1=X, which means it was not required; N2=1, Protection
1: General requirements. for basic Degree of protection
2 against vertically falling water drops
safety and essential performance

IEC 60601-1 (IEC

Medical electrical equipment – Part IPX2: N1=X, which means it was not required; N2=2, Protection
60529) Reference no.
1: General requirements. for basic Degree of protection against vertically falling water drops when ENCLOSURE tilted up to
6.3, Table D.3, Row
safety and essential performance 15°
2
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IEC 60601-1 (IEC Medical electrical equipment – Part
60529) 1: Part 1: General requirements. for
Reference no. Table basic safety and essential
6.3; D.3, Code 2 performance
Symbol for use in the labeling of
BS EN 15986:2011 medical devices — Requirements
Reference no. A.4 for labeling of medical devices
containing phthalates
Symbol for use in the labeling of
BS EN 15986:2011 medical devices — Requirements
Reference no. A.4 for labeling of medical devices
containing phthalates
Symbol for use in the labeling of
BS EN 15986:2011 medical devices — Requirements
Reference no. A.5 for labeling of medical devices
containing phthalates
Symbol for use in the labeling of
BS EN 15986 medical devices — Requirements
Annex B for labeling of medical devices
containing phthalates.
SYMBOL TITLE EXPLANATORY TEXT
IP33: N1=3, Protected against solid foreign objects of 2,5 mm Ø and
Degree of protection
greater; N2=3, Protected against spraying water
Contains or presence of
Medical device is derived from or manufactured from products
phthalate: benzyl butyl
containing phthalate: benzyl butyl phthalate (BBP)
phthalate (BIPingreBP)
Contains or presence of
phthalate: bis (2- Medical device is derived from or manufactured from products
ethylhexyl) phthalate containing phthalate: bis (2- ethylhexyl) phthalate (DEHP)
(DEHP)
Contains or presence of
phthalate: combination
Medical device is derived from or manufactured from products
of bis (2-ethylhexyl)
containing bis (2-ethylhexyl) phthalate (DEHP) and benzyl butyl
phthalate (DEHP) and
phthalate (BBP)
benzyl butyl phthalate
(BBP)
Negation symbol plus
Presence of phthalate Manufacturers wishing to communicate the meaning “does not” or “is
symbol, together not” where a symbol expressing this meaning does not exist, should
meaning free of follow the method set out in EN 80416- 3:2002, Clause 7
phthalates
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REFERENCE

ISO 7000 Graphical symbols for use on

Packaging unit To indicate the number of pieces in the package
Reference no. 2794 equipment.

ISO 7000 Graphical symbols for use on

This way up N/A
Reference no. 0623 equipment - registered symbols

To indicate that the item shall not be vertically stacked, either because
ISO 7000 Graphical symbols for use on
Do not stack of the nature of the transport packaging or because of the nature of the
Reference no. 2402 equipment-Registered symbols
items themselves

Graphical symbols for electrical

ISO 7000 To identify oil or other non-water base fluid. On an indicator to
equipment in medical practice - Oil; fluid
Reference no. 1056 identify oil or used to identify a fill cap
Registered symbols

ISO 7001
Graphical symbols - Public
Reference no. PI PF Telephone To indicate the location of public telephone
information symbols
017

ISO 7001
Graphical symbols - Public
Reference no. PI PF Hospital Indicates the location of a hospital
information symbols
002 Hospital
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REFERENCE

To identify the control whereby a bell may be temporarily

acknowledged or to indicate that the bell has been temporarily
ISO 7000 Graphical symbols for use on
Open here acknowledged
Reference no. 3079 equipment - registered symbols

Bell, cancel temporary

IEC 60417-1 To identify the control whereby a bell may be temporarily
Graphical symbols for Use on acknowledged;
Reference no. ISO acknowledged or to indicate that the bell has been temporarily
Equipment temporary
7000-5576-3 acknowledged
acknowledged

IEC 60417-1
Graphical symbols for use on
Reference no. ISO- Bell, cancel temporary To indicate the operating status of the bell being temporarily canceled
equipment
7000-5576-2

IEC 60417-1 Graphic symbols for use on

Serial interface To identify on a connector for a serial data connection
Reference no. 5850 electrical equipment

IEC 60417-1
ISO 7000-5569 Graphic symbols for use on To identify on a control that a function is locked or to show the
Locking, general
not IEC 60417 electrical equipment locked status
Reference no. 5569

IEC 60417-1 Graphic symbols for use on To identify on a control that a function is not locked or to show the
Unlocking
Reference no. 5570 electrical equipment unlocked status
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REFERENCE

IEC 60417-1
Graphical symbols for use on
Reference no. ISO Fuse To identify fuse boxes or their location
equipment
7000-5016

IEC 60417
Graphic symbols for use on
Reference no. ISO Battery, general On battery powered equipment
electrical equipment
7000-5001B

IEC 60417-1
Graphical symbols for use on Caution, risk of To identify equipment, for example, the welding power source, that
Reference no. ISO
equipment electrical shock has risk of electrical shock
7000-6042

IEC 60417-1
Graphical symbols for use on To identify the computer network itself or to indicate the connecting
Reference no. ISO Computer network
equipment terminals of the computer network
7000-5988

IEC 60417 Non-ionizing

Graphical Symbols for Use on
Reference no. 7000- electromagnetic N/A
Equipment
5140 radiation

IEC 60417 Graphical Symbols for Use on To indicate a reference to a nurse or the nursing staff, e.g. on a call
Nurse
Reference no. 5668 Equipment button
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REFERENCE

To identify the model number or type number of a product. In the

IEC 60417 Graphical Symbols for Use on
Model number application of this symbol, the model number or type number of the
Reference no. 6050 Equipment
product should be accompanied with this symbol

IEC 60417 Graphical Symbols for Use on

Inner diameter To indicate a reference to the inner diameter
Reference no. 5845 Equipment

IEC 60417 Graphical Symbols for Use on

Outer diameter To indicate a reference to the outer diameter
Reference no. 5846 Equipment

ASTM F2503 Standard practice for Making

3.1.13: An item that poses no known hazards resulting from exposure
Reference no. ASTM Medical Devices and other item for Magnetic Resonance
to any MR environment. MR Safe items are composed of materials
F2503; Table 2; safety in the magnetic resonance (MR) safe
that are electricaly nonconductive, nonmetallic, and nonmagnetic.
7.4.6.1; Fig. 6, 7 environment

Standard Practice for Marking
ASTM F2503
Medical Devices and Other Items
Reference no. Tabel
for Safety in the magnetic
2; 7.4.6.1; Fig 6,7
resonance environment.
3.3.1.11: an item with demonstrated safety in the MR environment
within defined conditions including conditions for the static magnetic
MR Conditional
field, the time-varying gradient magnetic fields and the
radiofrequency fields.
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REFERENCE

ASTM F2503
Reference no. Table Standard Practice for Marking
2, Symbol 7.3.3; Medical Devices and other Items 3.1.14: An item which poses unacceptable risks to the patient,
(MR) Unsafe
7.4.9.1; Fig. 9 for safety in the Magnetic medical staff or other persons within the MR environment
Resonance Environment

IEC-TR-60878
Graphical symbols for electrical To identify an entrance, for example exhaust gas entry for
Reference no. (ISO Input: entrance
equipment in medical practice measurement (for example of CO- value)
7000-0794)

IEC-TR-60878
Graphical symbols for electrical
Reference no. (ISO Output; exit To identify an exit, for example of an hydraulic pump
equipment in medical practice
7000-0795)

IEC-TR-60878
Graphical symbols for electrical To identify an entrance, for example exhaust gas entry for
Reference no. (ISO Input
equipment in medical practice measurement (for example of CO- value)
7000-5034)

IEC-TR-60878 To indicate packages containing electrostatic sensitive devices, or to

Graphical symbols for electrical Electrostatic sensitive
Reference no. (ISO identify a device or a connector that has not been tested for immunity
equipment in medical practice devices
7000-5134) to electrostatic discharge.

IEC-TR-60878
Graphic symbols for electrical To identify connecting means (e.g. plug or cord) to the power source
Reference no. (ISO Power Plug
equipment in medical practice (mains) or to identify the storage place for the connecting means
7000-5534)
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REFERENCE

IEC-TR-60878
Reference no. 1(ISO Graphical symbols on equipment Input/output To identify a combined input/output connector or mode
7000-5448)

IEC-TR-60878 Graphic symbols for use on

General symbol for To indicate that the marked item or its material is part of a recovery or
Reference no. ISO electrical equipment in a medical
recover/recyclable recycling process
7000-1135 practice

IEC-TR-60878 Graphic symbols for use on To indicate that the items shall not be vertically stacked
Stacking limit by
Reference no. IOS electrical equipment in a medical beyond the specified number, either because of the nature of the
number
7000-2403 practice transport packaging or because of the nature of the items themselves.

REGULATION (EU) 2017/745 OF

THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
EU 2017-745 EU (43) ‘CE marking of conformity’ or ‘CE marking’ means a marking
April 2017 on medical devices,
2017-746 by which a manufacturer indicates that a device is in conformity with
amending Directive 2001/83/ EC, CE marking
Reference no. the applicable requirements set out in this Regulation and other
Regulation (EC) No 178/2002 and
ANNEX V applicable Union harmonisation legislation providing for its affixing
Regulation (EC) No 1223/2009 and
repealing Council Directives
90/385/ EEC and 93/42/EEC

Separate collection for waste of electrical and electronic equipment.

DIRECTIVE
Do not dispose of battery
2012/19/ N/A Collect separately
in municipal waste. The symbol indicates separate collection for
EU (WEEE)
battery is required.
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REFERENCE

Replaced by DIRECTIVE
Directive 2002/96/
2012/19/EU which does NOT
EC (repealed).
contain this symbol.
Waste stream disposal
Do not dispose of electronic products in the general waste stream
status

Globally Harmonized System of

GHS
Classification and Labeling of Medical device contains materials that are highly flammable.
Reference no. Highly flammable
Chemicals (GHS), Eighth Revised Appropriate caution should be taken
1.4.10.4.2.3 A1.7
Edition

Caution: Federal law (USA) restricts this device to sale by or on the

N/A N/A Prescription Use Only
order of a licensed healthcare practitioner.

N/A N/A Collection time Time that a specific specimen was collected from the patient

N/A N/A Cut Directs health care practitioner to cut a package

N/A N/A Collection Date Date that a specific specimen was collected from the patient
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REFERENCE

N/A N/A Keep away from light Medical device should be shielded or kept away from light sources

Hydrogen gas is
N/A N/A Medical device generates hydrogen gas, caution
generated

N/A N/A Perforation Medical device packaging contains a perforation to aid in opening

Federal Communications
N/A 21 CFR Part 15 Meets FCC requirements per 21 CFR Part 15
Commission

On packaging, the Green Dot means that for such packaging a

financial contribution has been paid to a qualified national packaging
European Packaging and Packaging
EC/94/62 The Green Dot symbol recovery organization set up in accordance with the principles defined
Waste Directive
in European Packaging and Packaging Waste Directive 94/62 and the
respective national law.

Start panel sequence

N/A N/A N/A
number
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REFERENCE

End panel sequence

N/A N/A N/A
number

N/A N/A Do not freeze Indicates the medical device should not be frozen

Sterile™ Solution (for

N/A N/A ChloraPrep use only as For ChloraPrep use only as of July 2020
of July2020)

Russian product
N/A N/A Product compliant with GOST standard(s)
conformity mark

Ukrainian conformity
N/A N/A Product compliant with Resolution No. 753
mark

UkrSEPRO conformity
N/A N/A Product compliant with DSTU (Ukrainian regulatory requirements)
mark
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REFERENCE

Stainless steel
N/A N/A instruments of Russian Made in Russia from corrosion-resistant steel
origin

Products bearing this mark have been tested and certified in

Canadian and US
N/A N/A accordance with applicable US and Canadian electrical safety and
Certification mark
performance standards

Australian
N/A N/A Communications Complies with Australian Communications Requirements
Authority

Manufactured in the USA and/or applies to medical devices sold in

N/A N/A USA
the USA

Medical Devices — Symbols to be

ISO/DIS 15223- used with medical device labels,
1:2020(E) DRAFT labeling, and information to be Single sterile barrier
Indicates a single sterile barrier system
Reference no. 5.2.11. supplied — Part 1: General system
(ISO 7000-3723) requirements. (Draft of New
Version)
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REFERENCE
Medical Devices — Symbols to be
ISO 15223- 1:2016 used with medical device labels,
Reference no. 5.2.12
labeling, and information to be
supplied — Part 1: General
requirements.
Medical devices — Symbols to be
used with medical device labels,
ISO 15223- 1:2016
labelling and information to be
Reference no. 5.2.14
supplied – Part 1: General
requirements.
Medical devices — Symbols to be
used with medical device labels,
ISO 15223- 1:2016
labelling and information to be
Reference no. 5.2.13
supplied – Part 1: General
requirements.
N/A N/A
MedtechEurope.Org New IVD Regulation EU 2017/746
SYMBOL TITLE EXPLANATORY TEXT
Double sterile barrier
Indicates two sterile barrier systems
system
Single sterile barrier
Indicates a single sterile barrier system with protective packaging
system with protective
outside
packaging outside
Single sterile barrier
Indicates a single sterile barrier system with protective packaging
system with protective
inside
packaging inside
Length To indicate the approximate length medical device
This symbol indicates that the device is a self-test in vitro diagnostic
Device for self-testing device. This means that a lay person can use it even without formal
healthcare or medical experience
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REFERENCE

This symbol indicates that the device is only to be used in a near

Device for near-patient patient setting by a health professional. Typically, such tests are used
MedtechEurope.Org New IVD Regulation EU 2017/746
testing in ambulances, emergency units, patient homes, or workplaces etc. A
‘near patient test’ is not to be used by the patient themselves.

This symbol indicates that the device (applies to rapid tests only) is
not intended for self-testing. A rapid test with this symbol should only
Device not for self- be used by a trained medical or a lab professional in an appropriate
MedtechEurope.Org New IVD Regulation EU 2017/746
testing setting. Manufacturers may choose to add this symbol next to the ‘’for
near patient testing’’ symbol to emphasise the intended user of the
test.

This symbol indicates that the device (applies to rapid tests only) is
not intended for near-patient testing. A rapid test with this symbol on
Device not for near-
MedtechEurope.Org New IVD Regulation EU 2017/746 its label should only be used by a trained laboratory professional in a
patient testing
laboratory. This symbol should be put on rapid tests that are intended
for exclusive use in a laboratory environment.

Warning; Flammable
ISO 7010 WO21 N/A To warn of flammable material
Material

ISO 7000 ISO 7886- Graphical symbols for use on

Re-use prevention A feature that allows one use and prevents further uses
3 equipment