Symbol glossary definitions

SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT

ISO 15223- 1:2016
Reference no. 5.1.1. (ISO 7000- Manufacturer Indicates the medical device manufacturer
3082)

Authorized Representative in the

ISO 15223- 1:2016 Indicates the authorized representative in the European
European Community / European
Reference no. 5.1.2 Community / European Union
Union

ISO 15223- 1:2016

Indicates the date when the medical device was
Reference no. 5.1.3. (ISO 7000- Date of manufacture
manufactured
2497)

ISO 15223- 1:2016

Indicates the date after which the medical device is not to be
Reference no. 5.1.4. (ISO 7000- Use-by-date
used
2607)

ISO 15223- 1:2016

Indicates the manufacturer's batch code so that the batch or
Reference no. 5.1.5. (ISO 7000- Batch code
lot can be identified
2492)

ISO 15223- 1:2016

Indicates the manufacturer's catalog number so that the
Reference no. 5.1.6. (ISO 7000- Catalog number
medical device can be identified
2493)

ISO 15223- 1:2016

Indicates the manufacturer's serial number so that a specific
Reference no. 5.1.7. (ISO 7000- Serial number
medical device can be identified
2498)
ISO 15223- 1:2020(E) (E)
DRAFT
Country of manufacture To identify the country of manufacture of products
Reference no. 5.1.11. (ISO 7000-
6049)
SYMBOL STANDARD REFERENCE
ISO 15223- 1:2016
Reference no. 5.2.1. (ISO 7000-
2499)
ISO 15223- 1:2016
Reference no. 5.2.2. (ISO 7000-
2500)
ISO 15223-1:2016
Reference no. 5.2.4. (ISO 7000-
2501)
ISO 15223-1:2016
Reference no. 5.2.4. (ISO 7000-
2502)
ISO 7000-2503
Reference no. 2503
ISO 15223-1:2016
Reference no. 5.2.6.(ISO 7000-
2608)
ISO 15223- 1:2016
Reference no. 5.2.7. (ISO 7000-
2609)
ISO 15223- 1:2016
Reference no. 5.2.8. (ISO 7000-
2606)
SYMBOL TITLE EXPLANATORY TEXT
Indicates a medical device that has been subjected to a
Sterile
sterilization process
Sterilized using aseptic processing Indicates a medical device that has been manufactured using
techniques accepted aseptic techniques
Indicates a medical device that has been sterilized using
Sterilized using ethylene oxide
ethylene oxide.
Indicates a medical device that has been sterilized using
Sterilized using irradiation
irradiation
To indicate that the device is provided sterile and has been
Sterilized using steam or dry heat
sterilized using steam or dry heat
Do not resterilize Indicates a medical device that is not to be resterilized
Indicates a medical device that has not been subjected to a
Non-sterile
sterilization process
Indicates a medical device that should not be used if the
package has been damaged or opened and that the user
Do not use if package is damaged
should consult the instructions for use for additional
information
SYMBOL STANDARD REFERENCE
ISO 15223- 1:2016
Reference no. 5.2.9. (ISO 7000-
3084)
ISO 15223- 1:2016
Reference no. A.12, NOTE 1
ISO 15223- 1:2016
Reference no. A.12, NOTE 2
ISO/DIS 15223- 1:2020(E)
DRAFT
Single sterile barrier system
Reference no. 5.2.11. (ISO 7000-
3723)
ISO 15223- 1:2016
Reference no. 5.3.1. (ISO 7000-
0621)
ISO 15223- 1:2016
Reference no. 5.3.2. (ISO 7000-
0624)
ISO 15223- 1:2016 and ISO
15223-1:2020(E) DRAFT
Reference no. 5.3.4. (ISO 7000-
0626)
ISO 15223- 1:2016
Reference no. 5.3.5. (ISO 7000-
0534)
SYMBOL TITLE
Sterile fluid path
Sterile fluid path
Sterile fluid path
Fragile, handle with care
Keep away from sunlight
Keep away from rain
Lower limit of temperature
EXPLANATORY TEXT
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
A.12 Examples of use of symbol 5.2.9 for “Sterile fluid
path”
A.12 Examples of use of symbol 5.2.9 for “Sterile fluid
path”
Indicates a single sterile barrier system
Indicates a medical device that can be broken or damaged if
not handled carefully
Indicates a medical device that needs protection from light
sources
Indicates a medical device that needs protection from
moisture
Indicates the lower limit of temperature to which the
medical device can be safely exposed
SYMBOL STANDARD REFERENCE
ISO 15223- 1:2016
Reference no. 5.3.6. (ISO 7000-
0533)
ISO 15223- 1:2016
Reference no. 5.3.7. (ISO 7000-
0632)
ISO 15223- 1:2016
Reference no. 5.3.8. (ISO 7000-
2620)
ISO
15223- 1:2016 Reference no.
5.3.9 (ISO 7000-2621)
1:2016
Reference no. 5.4.1. (ISO 7000-
0659)
ISO 15223-1:2016E
Reference no. 5.4.2. (ISO 7000-
1051)
ISO 15223-1:2016 and ISO
15223-1:2020(E)
Reference no. 5.4.3. (ISO 7000-
1641)
ISO 15223-1:2016
Reference no. A.15
SYMBOL TITLE
Upper limit of temperature
Temperature limit
Humidity limitation
Atmospheric Pressure limitation
Biological risks
Do not re-use
Consult instructions for use or
Consult electronic instructions for
use
Consult instructions for use or
consult electronic instructions for use for an electronic instruction for
use
EXPLANATORY TEXT
Indicates the upper limit of temperature to which the
medical device can be safely exposed
Indicates the temperature limits to which the medical device
can be safely exposed
Indicates the range of humidity t which the medical device
can be safely exposed
Indicates the range of atmospheric pressure to which the
medical device can be safely exposed.
Indicates that there are potential biological risks associated
with the medical device
Indicates a medical device that is intended for one single use
only
Indicates the need for the user to consult the instructions for
use
Indicates consult instructions for
use (eIFU)
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT
To indicate that caution is necessary when operating the
ISO 15223- 1:2016 device or control close to where the symbol is placed, or to
Reference no. 5.4.4. (ISO 7000- Caution indicate that the current situation needs operator awareness
0434A) or operator action in order to avoid undesirable
consequences
ISO 15223- 1:2016 Indicates the presence of dry natural rubber or natural rubber
Contains or presence of natural
Reference no. 5.4.5. (ISO 7000, latex as a material of construction within the medical device
rubber latex
symbol 2025) or the packaging of a medical device
ISO/DIS 15223- 1:2020(E)
DRAFT Contains human blood or plasma Indicates a medical device contains or incorporates human
Reference no. 5.4.6 (ISO 7000- derivatives blood products or plasma derivatives
3701)
ISO/DIS 15223- 1:2020(E)
DRAFT Indicates a medical device that contains or incorporates a
Contains a medicinal substance
Reference no. 5.4.7. (ISO 7000- medicinal substance
3702)
ISO/DIS 15223- 1:2020(E)
DRAFT Contains biological material of Indicates a medical device that contains biological tissue,
Reference no. 5.4.8. (ISO 7000- animal origin cells, or their derivatives, of animal origin
3699)
ISO/DIS 15223- 1:2020(E)
DRAFT Contains biological material of Indicates a medical device that contains biological tissue,
Reference no. 5.4.9. (ISO 7000- human origin cells, or their derivatives, of human origin
3700)
ISO/DIS 15223- 1:2020(E)
Indicates a medical device that contains substances that can
DRAFT
Contains hazardous substances be carcinogenic, mutagenic, reprotoxic (CMR), or
Reference no. 5.4.10. (ISO 7000-
substances with endocrine-disrupting properties
3723)
ISO/DIS 15223- 1:2020(E)
DRAFT Indicates a medical device that may be used multiple times
Single patient-multiple use
Reference no. 5.4.12. (ISO 7000- (multiple procedures) on a single patient
3706)
SYMBOL STANDARD REFERENCE
ISO 15223-1:2016 and ISO
15223-1:2020(E)
Reference no. 5.5.1.
ISO 15223- 1:2016
Reference no. 5.5.2.
ISO 15223- 1:2016
Reference no. 5.5.3. (ISO 7000-
2495)
ISO 15223- 1:2016
Reference no. 5.5.4. (ISO 7000-
2496)
ISO 15223- 1:2016
Reference no. 5.5.5. (ISO 7000-
0518)
ISO 15223- 1:2016
Reference no. 5.5.6. (ISO 7000-
3083)
ISO 15223- 1:2016
Reference no. 5.6.2. (ISO 7000-
2722)
ISO 15223- 1:2016
Reference no. 5.6.3. (ISO 7000-
2724)
ISO 7000
Reference no. 2723
SYMBOL TITLE EXPLANATORY TEXT
Indicates a medical device that is intended to be used as an
In vitro diagnostic medical
in vitro diagnostic medical device
Indicates a control material that is intended to verify the
Control
performance of another medical device
Indicates a control material that is intended to verify the
Negative control
results in the expected negative range
Indicates a control material that is intended to verify the
Positive control
results in the expected positive range
Indicates the total number of IVD tests that can be
Contains sufficient for <n> tests
performed with the IVD medical device.
Indicates an IVD device that is intended to be used only for
For IVD performance evaluation
evaluating its performance characteristics before it is placed
only
on the market for medical diagnostic use
Fluid path Indicates the presence of a fluid path
Non-pyrogenic Indicates a medical device that is non-pyrogenic
Non-pyrogenic fluid On medical devices: to indicate that the fluid path is non-
path pyrogenic
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT
ISO 15223-1:2016
Drops per milliliter
Reference no. 5.6.4. (ISO 7000- Indicates the number of drops per milliliter
path
2726)
Indicates an infusion or transfusion
ISO 15223- 1:2016
system of the medical device that
Reference no. 5.6.5. (ISO 7000- Liquid filter with pore size
contains a filter of a particular
2727)
nominal pore size
ISO 15223- 1:2016
Indicates a unique number associated with an individual
Reference no. 5.7.1. (ISO 7000- Patient number
patient
2610)
ISO/DIS 15223- 1:2020(E)
DRAFT
Patient identification Indicates the identification data of the patient
Reference no. 5.7.3 (ISO 7000-
5664)
ISO/DIS 15223- 1:2020(E)
DRAFT Indicates a website where a patient may obtain additional
Patient information website
Reference no. 5.7.4 (ISO 7000- information on the medical product
3705)
ISO/DIS 15223-1:2020(E)
DRAFT To indicate the address of the health care center or doctor
Health care center or doctor
Reference no. 5.7.5. (ISO 7001-PI where medical information about the patient may be found
PF 044)
ISO/DIS 15223- 1:2020(E)
DRAFT To identify the date that information was entered, or a
Date
Reference no. 5.7.6 (ISO 7000- medical procedure took place
5662)
ISO/DIS 15223- 1:2020(E)
DRAFT Medical device Indicates the item is a medical device
Reference no. 5.7.7
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT
ISO 15223-1:2020(E) DRAFT To identify that the original medical device information has
Reference no. 5.7.8. (ISO 7000- Translation undergone a translation which supplements or replaces the
3728) original information

ISO 15223-1:2020(E) DRAFT

To identify that a modification to the original medical device
Reference no. 5.7.9. (ISO 7000- Repackaging
packaging configuration has occurred
3727)
To indicate on the rating plate
ICE 60601- 1
that the equipment is suitable for
Reference no. Table D1, Symbol Alternating current
alternating current only; to identify
8 (IEC 60417-5032)
relevant terminals
IEC 60601-1
To indicate on the rating plate that the equipment is suitable
Reference no. Table D.1, Symbol Direct current
for direct current only; to identify relevant terminals
4 (IEC 60417- 5031)
To identify any terminal which is intended for connection to
IEC 60601-1
Protective earth; protective an external conductor for protection against electric shock in
Reference no. Table D.1, Symbol
ground case of a fault, or the terminal of a protective earth (ground)
6 (IEC 60417- 5019)
electrode
To identify the terminals which, when
connected together, bring the various
ICE 60601- 1
parts of equipment or of a system
Reference no. Table D1, Symbol Equipotentiality
to the same potential, not necessarily
8 (IEC 60417-5021)
being the earth (ground) potential,
e.g. for local bonding
IEC 60417
To identify equipment meeting the safety requirements
Reference no. Table D.1, Symbol Class II equipment
specified for Class II equipment according to IEC 61140
9 (IEC 60417- 5172)

IEC 60601-1, Reference no. Table

D.1, Symbol 19 (ICE 60417- TYPE B APPLIED PART N/A
5480)
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT
IEC 60601-1, Reference no. Table
D.2, Symbol 20 (ICE 60417- TYPE BF APPLIED PART N/A
5333)

IEC 60601-1 Reference no. Table

To identify a type CF applied part complying with IEC
D.1, Symbol 21 (IEC 60417- Type CF applied part.
60601-1
5335)

IEC 60601-1 Reference no. Table

Defibrillation-proof Type BF To identify a defibrillation-proof type BF applied part
D.1, Symbol 26 (IEC 60417-
applied part complying with IEC 60601-1
5334)

IEC 60601-1 Reference no. Table

Defibrillation-proof Type CF To identify a defibrillation-proof Type CF applied part
D.1, Symbol 21 (IEC 60417-
applied part complying with IEC 60601-1
5336)

IEC 60601-1 Database Reference

no. Table D2, Safety sign 5 (ISO No pushing N/A
7010-P017)

EC 60601-1, Reference no. Table

Refer to instruction
D.2, Safety sign 10 (ISO 7010- N/A
manual/booklet
M002)
N1 = 0 Non-protected; 1 Protected against solid foreign
objects of 50 mm Ø and greater; 2 Protected against solid
foreign objects of 12,5 mm Ø and greater; 3 Protected
against solid foreign objects of 2,5 mm Ø and greater; 4
Protected against solid foreign objects of 1,0 mm Ø and
IEC 60601-1 (IEC 60529) Table
greater; 5 Dust-protected; 6 Dust-tight N2 = 0 Non-
D.3; Code 2 6.3; Table D.3; Code Degree of protection
protected; 1 Protection against vertically falling water drops;
2
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 against powerful water jets; 7
Protected against the effects of temporary immersion in
SYMBOL STANDARD REFERENCE
IEC 60601-1, (IEC 60529)
Reference no. 6.3; Table D.3,
Code 2
IEC 60601-1, (IEC 60529)
Reference no. 6.3; Table D.3,
Code 2 (Refer to IEC 60529; see
7.2.9 and 11.6.5)
IEC 60601-1 (IEC 60529)
Reference no. 6.3; Table D.3;
Code 2
IEC 60601-1 (IEC 60529)
Reference no. 6.3, Table D.3,
Row 2
IEC 60601-1 (IEC 60529)
Reference no. Table 6.3; D.3,
Code 2
BS EN 15986:2011
Reference no. A.4
BS EN 15986:2011
Reference no. A.2
BS EN 15986:2011
Reference no. A.5
SYMBOL TITLE
Degree of protection
Degree of protection
Degree of protection
Degree of protection
Degree of protection
Contains or presence of phthalate:
benzyl butyl phthalate
(BIPingreBP)
Contains or presence of phthalate: Medical device is derived from or manufactured from
bis (2- ethylhexyl) phthalate
(DEHP)
Contains or presence of phthalate:
combination of bis (2-ethylhexyl)
phthalate (DEHP) and benzyl
butyl phthalate (BBP)
EXPLANATORY TEXT
water; 8 Protected against the effects of continuous
immersion in water
IP22: N1=2, Protected against solid foreign objects of 12,5
mm Ø and greater; N2=2, Protection against vertically
falling water drops when ENCLOSURE tilted up to 15°
IP27: N1=2, Protected against solid foreign objects of 12,5
mm Ø and greater; N2=7, Protected against the effects of
temporary immersion in water
IPX1: N1=X, which means it was not required; N2=1,
Protection against vertically falling water drops
IPX2: N1=X, which means it was not required; N2=2,
Protection against vertically falling water drops when
ENCLOSURE tilted up to 15°
IP33: N1=3, Protected against solid foreign objects of 2,5
mm Ø and greater; N2=3, Protected against spraying water
Medical device is derived from or manufactured from
products containing phthalate: benzyl butyl phthalate (BBP)
products containing phthalate: bis (2- ethylhexyl) phthalate
(DEHP)
Medical device is derived from or manufactured from
products containing bis (2-ethylhexyl) phthalate (DEHP)
and benzyl butyl phthalate (BBP)
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT
Manufacturers wishing to communicate the meaning “does
Negation symbol plus Presence of
BS EN 15986 not” or “is not” where a symbol expressing this meaning
phthalate symbol, together
Annex B does not exist, should follow the method set out in EN
meaning free of phthalates
80416- 3:2002, Clause 7

ISO 7000
Packaging unit To indicate the number of pieces in the package
Reference no. 2794

ISO 7000
This way up N/A
Reference no. 0623

To indicate that the item shall not be vertically stacked,

ISO 7000
Do not stack either because of the nature of the transport packaging or
Reference no. 2402
because of the nature of the items themselves

ISO 7000 To identify oil or other non-water base fluid. On an indicator

Oil;fluid
Reference no. 1056 to identify oil or used to identify a fill cap

ISO 7001
Telephone To indicate the location of public telephone
Reference no. PI PF 017

ISO 7001 Reference no.

Hospital Indicates the location of a hospital
PI PF 002 Hospital

Bell, cancel temparary
IEC 60417-1
acknowledged; temporary
Reference no. ISO 7000-5576-3
acknowledged
To identify the control whereby a bell may be temporarily
acknowledged or to indicate that the bell has
been temporarily acknowledged
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT

IEC 60417-1 To indicate the operating status of the bell being temporarily
Bell, cancel temporary
Reference no. ISO-7000-5576-2 cancelled

IEC 60417-1
Serial interface To identify on a connector for a serial data connection
Reference no. 5850

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

IEC 60417-1 To identify on a control that a function is not locked or to

Unlocking
Reference no. 5570 show the unlocked status

IEC 60417-1 Reference no. ISO

Fuse To identify fuse boxes or their location
7000-5016

IEC 60417
Battery, general On battery powered equipment
Reference no. ISO 7000-5001B

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

IEC 60417-1 Reference no. ISO To identify the computer network itself or to indicate the
Computer network
7000-5988 connecting terminals of the computer network
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT

IEC 60417 Non-ionizing electromagnetic

N/A
Reference no. ISO 7000-5140 radiation

3.1.13: An item that poses no known hazards resulting from

ASTM F2503
exposure to any MR environment. MR Safe items are
Reference no. ASTM F2503; Magnetic Resonance (MR) safe
composed of materials that are electricaly nonconductive,
Table 2; 7.4.6.1; Fig. 6, 7
nonmetallic, and nonmagnetic.
3.3.1.11: an item with demonstrated safety in the MR
ASTM F2503
environment within defined conditions including conditions
Reference no. Tabel 2; 7.4.6.1; MR Conditional
for the static magnetic field, the time-varying gradient
Fig 6,7
magnetic fields and the radiofrequency fields.
ASTM F2503
3.1.14: An item which poses unacceptable risks to the
Reference no. Table 2, Symbol
(MR) Unsafe patient, medical staff or other persons within the MR
7.3.3;
environment
7.4.9.1; Fig. 9

IEC-TR-60878 To identify an entrance, for example exhaust gas entry for

Input: entrance
Reference no. (ISO 7000-0794) measurement (for example of CO- value)

IEC-TR-60878
Output; exit To identify an exit, for example of an hydraulic pump
Reference no. (ISO 7000-0795)

IEC-TR-60878 To identify an entrance, for example exhaust gas entry for

Input
Reference no. (ISO 7000-5034) measurement (for example of CO- value)

To indicate packages containing electrostatic sensitive

IEC-TR-60878
Electrostatic sensitive devices devices, or to identify a device or a connector that has not
Reference no. (ISO 7000-5134)
been tested for immunity to electrostatic discharge.
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT
To identify connecting means (e.g. plug or cord) to the
IEC-TR-60878
Power Plug power source (mains) or to identify the storage place for the
Reference no. (ISO 7000-5534)
connecting means

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

IEC-TR-60878 General symbol for To indicate that the marked item or its material is part of a
Reference no. ISO 7000-1135 recover/recyclable recovery or recycling process

To indicate that the items shall not be vertically stacked

IEC-TR-60878 beyond the specified number, either because of the nature of
Stacking limit by number
Reference no. IOS 7000-2403 the transport packaging or because of the nature of the items
themselves.
(43) ‘CE marking of conformity’ or ‘CE marking’ means a
marking by which a manufacturer indicates that a device is
EU 2017-745 EU 2017-746
CE marking in conformity with the applicable requirements set out in this
Reference no. ANNEX V
Regulation and other applicable Union harmonisation
legislation providing for its affixing
Separate collection for waste of electrical and electronic
DIRECTIVE
equipment. Do not dispose of battery
2012/19/ Collect separately
in municipal waste. The symbol indicates separate collection
EU (WEEE)
for battery is required.

Do not dispose of electronic products in the general waste

Directive 2002/96/ EC (repealed). Waste stream disposal status
stream

GHS Medical device contains materials that are highly

Highly flammable
Reference no. 1.4.10.4.2.3 A1.7 flammable. Appropriate caution should be taken
SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT

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

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

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

N/A Peel here Directs health care practitioner to peel open a package

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

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

Medical device should be shielded or kept away from light

N/A Keep away from light
sources

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

Medical device packaging contains a perforation to aid in

N/A Perforation
opening

N/A 21 CFR Part 15 Meets FCC requirements per 21 CFR Part 15

SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT

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

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

Product compliant with DSTU (Ukrainian regulatory

N/A UkrSEPRO conformity mark
requirements)

Stainless steel instruments of

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

Products bearing this mark have been tested and certified in

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

Australian Communications
N/A Complies with Australian Communications Requirements
Authority

On packaging, the Green Dot means that for such packaging

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

Manufactured in the USA and/or applies to medical devices

N/A USA
sold in the USA
 SYMBOL STANDARD REFERENCE SYMBOL TITLE EXPLANATORY TEXT

Start panel sequence number

N/A N/A
End panel sequence number

20.2 in the 2017/746 IVDR Regulation (j) where relevant, an

indication of the net quantity of contents, expressed in terms
N/A Quantity of weight or volume, numerical count, or any combination
of thereof, or other terms which accurately reflect the
contents of the package;

Last updated: 5/24/2020 Version 1