Gap Analysis ISO 15223-1 (2016 Vs 2021)
EN ISO 15223-1:2016
Scope
This document identifies requirements
for symbols used in medical device
labelling that convey information on the
safe and effective use of medical
devices. It also lists symbols that satisfy
the requirements of this document.
This document is applicable to symbols
used in a broad spectrum of medical
devices, which are marketed globally
and therefore need to meet different
regulatory requirements.
These symbols may be used on the
medical device itself, on its packaging or
in the associated
documentation.
The requirements of this
document are not intended to apply to
symbols specified in
other standards.
Normative References
ISO 70001), Graphical symbols for use
on equipment — Registered symbols
ISO 8601, Data elements and
interchange formats — Information
interchange — Representation of
dates and times
EN ISO 15223-1:2021 CHANGES COMMENT
Scope
This document identifies requirements for
symbols used in medical device labelling that
convey information on the safe and effective
use of medical devices. It also lists symbols
that satisfy the requirements of this
document.
This document is applicable to symbols used Same
in a broad spectrum of medical devices,
which are marketed globally and therefore
need to meet different regulatory
requirements.
These symbols are marked on the medical
device itself, placed on its packaging or
placed in the associated accompanying
information. The requirements of this
document are not intended to apply to
symbols specified in other standards.
Normative References
ISO 7000 (database), Graphical symbols for
use on equipment — Registered symbols
ISO 7001:2019, Graphical symbols — Public According to new
information symbols references, ……
ISO 8601-1:2019, Date and time —
Representations for information interchange
— Part 1: Basic rules ISO 8601-2:2019, Date
and time — Representations
for information interchange — Part 2:
Extensions
 Gap Analysis ISO 15223-1 (2016 Vs 2021)
ISO 15223-2, Medical devices —
Symbols to be used with medical
device labels, labelling, and
information
to be supplied — Part 2: Symbol
development, selection and validation
Terms and definitions
3.1 to 3.6
ISO 14971:2019, Medical devices -- Application of
risk management to medical devices
ISO 13485:2016, Medical devices – Quality
management systems – Requirements for
regulatory purposes
ISO 15223-2:2010, Medical devices — Symbols to
be used with medical device labels, labelling, and
information to be supplied — Part 2: Symbol
development, selection and validation
ISO 20417 1, Medical Devices - Information to
be supplied by the manufacturer
IEC 60417 (database), Graphical symbols for use
on equipment
IEC 80416-1:2008, Basic principles for graphical
symbols for use on equipment — Part 1: Creation
of
graphical symbols for registration
Terms and definitions New terms and
definitions will examine
3.1 to 3.22 and if we need a
change, they will
use in procedure.

ISO 15223-1:2016 Table 1 — Symbols to

ISO 15223-1:2021 Table 1 — Symbols to convey
convey information essential for
proper use information essential for proper use
5.1.1 5.1.1 Same
5.1.2 5.1.2 Same
5.1.3 5.1.3 Same
5.1.4 5.1.4 Same
5.1.5 5.1.5 Same
5.1.6 5.1.6 Same
 Gap Analysis ISO 15223-1 (2016 Vs 2021)
5.1.7 5.1.7 Same
5.1.8 - Importer New Symbol
New Symbol
5.1.9 - Distributor
N/A
5.1.10 – Model Number New Symbol
New Symbol
5.1.11 - Country of manufacturer
5.2.1 5.2.1 Same
5.2.2 5.2.2 Same
5.2.3 5.2.3 Same
5.2.4 5.2.4 Same
5.2.5 5.2.5 Same
5.2.6 5.2.6 Same
5.2.7 5.2.7 Same
5.2.8 5.2.8 Same
5.2.9 5.2.9 Same
5.2.10 - Sterilized using vaporized
New Symbol
hydrogen peroxide
5.2.11 - Single sterile barrier New Symbol
system
N/A
5.2.12 - Double sterile barrier New Symbol
system
5.2.13 - Single sterile barrier system
New Symbol
with protective packaging inside
5.2.14 - Single sterile barrier
New Symbol
system
with protective packaging outside
5.3.1 5.3.1 Same
5.3.2 5.3.2 Same
5.3.3 5.3.3 Same
 Gap Analysis ISO 15223-1 (2016 Vs 2021)
5.3.4 5.3.4 Same
5.3.5 5.3.5 Same
5.3.6 5.3.6 Same
5.3.7 5.3.7 Same
5.3.8 5.3.8 Same
5.3.9 5.3.9 Same
5.4.1 5.4.1 Same
5.4.2 5.4.2 Same
5.4.3 5.4.3 Same
5.4.4 5.4.4 Same
5.4.5 5.4.5 Same
5.4.6 – Contains human blood or plasma
New Symbol
derivatives

5.4.7 - Contains a medicinal New Symbol

substance
5.4.8 - Contains biological material of
New Symbol
animal origin
N/A 5.4.9 - Contains biological material of
New Symbol
human origin

5.4.10 - Contains hazardous substances New Symbol

5.4.11 - Contains nano materials New Symbol

5.4.12 - Single patient multiple use New Symbol

N/A Our products are

5.5 IVD-specific 5.5 IVD-specific
medical
device.
5.6.1 5.6.1 Same
 Gap Analysis ISO 15223-1 (2016 Vs 2021)
5.6.2 5.6.2 Same
5.6.3 5.6.3 Same
5.6.4 5.6.4 Same
5.6.5 5.6.5 Same
5.6.6 5.6.6 Same
5.7.1 5.7.1 Same

5.7.2 - Patient name New Symbol

5.7.3 - Patient identification New Symbol

5.7.4 - Patient information website New Symbol

5.7.5 - Health care center or doctor New Symbol

N/A
5.7.6 - Date New Symbol

5.7.7 - Medical device New Symbol

5.7.8 - Translation
New Symbol

5.7.9 - Repackaging New Symbol

5.7.10 - Unique Device Identifier New Symbol