World J Curr Med Pharm Res.

2022; 4(3): 40-44

Review Article

WORLD JOURNAL OF CURRENT MEDICAL AND

PHARMACEUTICAL RESEARCH
www.wjcmpr.com ISSN: 2582-0222

Symbols to Be Used In Labelling Of Medical Devices

Dasari Yuktha Lakshmi1, Ramaiah Maddi2
1,2Departmentof Pharmaceutical Regulatory Affairs, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, A.P., India

Abstract
This document specifies different symbols used to express information supplied for a medical device. This document is applicable to
symbols used in a broad spectrum of medical devices, that are available globally and to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging, or in the accompanying information. The requirements of
this document are not intended to apply to symbols specified in other standards.

Article History: Keywords: *Corresponding Author

Received: 02.04.2022 Symbol, Labelling, Medical device. Dasari Yuktha Lakshmi
Revised: 15.04.2022 DOI: https://doi.org/10.37022/wjcmpr.v4i3.213
Accepted: 10.05.2022

This article is licensed under a Creative Commons Attribution-Non-commercial 4.0 International License.
Copyright © 2022 Author(s) retain the copyright of this article.

Introduction 2. Exporters probably use labels with stand-alone symbols

Definition because it is cheaper to a design labeling with a common set of
A medical device can be any instrument, apparatus, implement, stand-alone symbols versus creating a labelling with no
machine, appliance, implant, reagent for in vitro use, software, symbols for each nation with different language.
material, or another similar or related article, intended by the 3. The use of graphical symbols as an alternative to written text
manufacturer to be used, alone or in combination for the has many advantages for manufactures who have space
medical purpose [1]. limitations on their labels.
The term Labelling includes all information provided with the 4. Graphical symbols are items that carry information essential
device. This includes labels, symbols, warnings, instructions, or for their safe and proper use.
control labels applied to the device or incorporated into the 5. Symbols used in medical device labeling convey information
design by color, printing, machining, or molding [2]. on the safe and effective use of medical devices [5].
The symbol is a graphical representation appearing on the Classification of Medical Devices
label and/or associated documentation of a medical device that Medical devices are classified into classes based on the
communicates characteristic information without the need for intended use and risk that a device enacts on the patient/ user
the supplier or receiver of the information to have knowledge [6, 7, 8, 9, and 10].
of the language of a particular nation or people [3]. Medical device classification in different countries:
ISO15223-1:2021 identifies requirements for symbols used in Countries Medical Device Classification
medical device labeling that convey information on the safe Class-
INDIA Class-A Class-B Class-C
and effective use of medical devices. It also lists symbols that D
satisfy the requirements of this document. USA Class-I Class-II Class-III -
ISO 15223-1:2021 is applicable to symbols used in a broad Class-IIa,
EU Class-I Class-III -
spectrum of medical devices, which are marketed globally and IIb
therefore need to meet different regulatory requirements. Class-
CANADA Class-I Class-II Class-III
These symbols may be used on the medical device itself, on its IV
packaging, or in the associated documentation. The Class-IIa,
requirements of this document are not intended to apply to AUSTRALIA Class-I Class-III -
IIb
symbols specified in other standards [4]. *Note: In the classification of Medical devices, as the level of
classes increases the level of risk increases, similarly decrease
The necessity of using symbols in labeling of Medical in the level of classes decreases the level of risk.
devices
1. The labeling of each uniquely labeled medical device can Different Symbols Used in Labelling of Medical Device
communicate the same information using stand-alone symbols Different symbols used in the labeling of medical devices which
or symbols with adjacent explanatory text. are marketed globally are given below [3, 11, 12]

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 Dasari Yuktha Lakshmi et al, World J Curr Med Pharm Res. 2022; 4(3):40-44

Date of Medical Device Unique Device Identifier

Manufacturer
Manufacturer Use-by Date

EC Rep Batch code Catalog# Serial#

Non-sterile

Sterilized using Sterilized using

sterile Ethylene oxide Sterile Fluid Path-EO Sterile Fluid Path- R
irradiation (ETO Ethylene- Oxide) (Irradiation)

Fragile, handle Keep away from Humidity limitation Do not use if package is
with care sunlight Keep dry damaged

Consult instructions for Consult instructions for use

Upper limit of use (Electronic Format)
Lower limit of Temperature limit
temperature temperature

caution Contains or presence Product is not made

of natural rubber with natural rubber Drops per milliliter
latex latex Non-pyrogenic

CE Mark European
Liquid filter with Labeling Conformity CE Mark with Notified
port size One-way Valve
Body Reference # ###

Contains or presence of
Does not contain Phthalates bis(2- Contains or presence of
Alert Does not contain
DEHP ethylhexyl phthalates Phthalates bis(2-ethylhexyl
lead
(DEHP) phthalates (DEHP)

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Protected against Protected against

Quantity Protected against vertically falling Class 1 Mains Protection
dripping water spraying water
water drops

General Warning General Mandatory

Warning Electricity Refer to instruction Lead Waste Disposal
Sign Action Sign manual/ booklet

To indicate correct
upright position of Atmospheric pressure
WEEE Dangerous Voltage RF Transmitter
the transport package Limitation

Wired Ethernet Alarm Volume Equipotential Terminal

Interface Port Output Terminal Certification Mark
Control (Ground)

Type CF Part Type BF Part Regulatory FCC Compliance Mark Wireless Registration
Compliance Mark

Bell Bell Cancel Locking, general Country of Manufacture

CSA Compliance

Single sterile barrier

Single sterile Double sterile Single sterile barrier
system with
barrier system barrier system system with protective Importer
protective packaging
packaging outside
inside

Sterilized using
Model number vaporized Hydrogen
Distributor peroxide Health care center or Date
doctor

Patient number Patient information Single patient – multiple

Patient name Patient identification
website use

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Contains Contains biological Contains biological

Contains a medicinal Contains hazardous
humanblood or material of animal material of human origin
substance materials
plasma derivatives origin

Contains Nano Repackaging

Translation Do not re-use Do not re-sterilize
materials

Contains sufficient Magnetic Resonance

Biological risk for <n> test (MR) safe MR Condition
(MR) Unsafe

Negative control Degree of protection

Control Positive control Serial interface

Defibrillation proof Defibrillation proof

No pushing Type CF applied part Type BF applied part General symbol for
Highly flammable
recover/ recyclable

Fluid path Non-pyrogenic fluid Protective earth;

Class II equipment Do not stack
path protective ground

Unlocking For IVD performance Cut Oil; Fluid

evaluation only Stacking limit by number

Alternating Direct current Output; exit Input; entrance Input/output

current

Conclusion 3. Symbols to be used on labelling (ISO 15223) &

Therefore, the symbols used on the labeling of medical devices Information to … - BSI, accessed 22 March 2022, <
convey information about the safety and effective use of https://www.bsigroup.com >
medical devices, which are marketed globally and therefore 4. ISO 15223-1:2016 – Medical devices — Symbols to be
meet different regulatory requirements. used with … , accessed 22 March 2022, <
https://www.iso.org >
References 5. Use of Symbols in Labeling – US Food and Drug
1. Medical device Definition, accessed 22 March 2022, < Administration, accessed 22 March 2022, <
https://www.who.int/health-topics/medical- https://www.fda.gov >
devices#tab=tab_1> 6. Classificationg1.pdf – CDSCO, accessed 22 March
2. Labeling definition, accessed 22 March 2022, 2022, < https://cdsco.gov.in >
<https://starfishmedical.com/blog/medical-device- 7. Classify Your Medical Device | FDA, accessed 22
labeling/#:~:text=When%20referring%20to%20med March 2022, < https://www.fda.gov >
ical%20devices,coding%2C%20printing%2C%20mac 8. MDCG 2021-24 Guidance on classification of medical
hining%20or%20molding > device, accessed 22 March 2022,
< https://ec.europa.eu >
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9. Classification of Medical devices – Canada, accessed
22 March 2022,
<https://medicaldevices.freyrsolutions.com/medical-
devices-regulatory-services-canada>
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ga-device-
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