Symbols Glossary
SymbolSymbol Title

Manufacturer

Authorized
representative in theEuropean Community/European Union

Date of manufacture

Use-by date

Description of Symbol

Indicates the medical device

ISO 15223-1:2016 5.1.1

manufacturer

ISO 15223-1:2021 5.1.1

Indicates the authorized representativein the European Community/ EuropeanUnion

device was manufactured

ISO 15223-1:2021 5.1.3

Indicates the date after which theISO 15223-1:2016 5.1.4

medical device is not to be used

ISO 15223-1:2021 5.1.4

code so that the batch or lot can be

Indicates the manufacturer’s catalogue
number so that the medical device canbe identified

Version 2: Last update 22, Feb. 2024

ISO 15223-1:2021 5.1.2

ISO 15223-1:2016 5.1.3

identified

Catalogue numberISO 15223-1:2016 5.1.2

Indicates the date when the medical

Indicates the manufacturer’s batch
Batch code

Standard Reference

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ISO 15223-1:2016 5.1.5
ISO 15223-1:2021 5.1.5

ISO 15223-1:2016 5.1.6
ISO 15223-1:2021 5.1.6

Symbols Glossary
SymbolSymbol Title

Importer

Description of Symbol

Indicates the entity importing themedical device into the locale

Standard Reference

ISO 15223-1:2021 5.1.8

Sterilized using ethylene

Indicates a medical device that has

ISO 15223-1:2016 5.2.3

oxidebeen sterilized using ethylene oxide

ISO 15223-1:2021 5.2.3

Indicates a medical device that is not toISO 15223-1:2016 5.2.6

be resterilized

ISO 15223-1:2021 5.2.6

Indicates a medical device that has not

ISO 15223-1:2016 5.2.7

been subjected to a sterilization process

ISO 15223-1:2021 5.2.7

Do not resterilize

Non-sterile

Indicates that a medical device thatDo not use if package isshould not be used if the package hasdamaged and consult

been damaged or opened and that theinstructions for use

user should consult the instructions for

ISO 15223-1:2016 5.2.8
ISO 15223-1:2021 5.2.8

use for additional information

Single sterile barriersystem

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Indicates a single sterile barrier system

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ISO 15223-1:2021 5.2.11

Symbols Glossary
SymbolSymbol Title

Do not re-use

Consult instructions foruse or consult electronic
instructions for use

Description of SymbolStandard Reference

Indicates a medical device that isISO 15223-1:2016 5.4.2intended for one single use only

ISO 15223-1:2021 5.4.2

Indicates the need for the user toISO 15223-1:2016 5.4.3

consult the instructions for use

ISO 15223-1:2021 5.4.3

Indicates a medical device that contains
Contains hazardous
substances

substances that can be carcinogenic,mutagenic, reprotoxic (CMR), orsubstances with endocrine disrupting

ISO 15223-1:2016 5.4.10
ISO 15223-1:2021 5.4.10

properties

Medical device

Unique device identifier

Indicates the item is a medical device

Indicates a carrier that contains uniquedevice identifier information

ISO 15223-1:2021 5.7.7

ISO 15223-1:2021 5.7.10

Caution: Federal law restricts thisOr

Prescription use only

device to sale by or on the order of aphysician

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21 CFR 801.109

Symbols Glossary
SymbolSymbol Title

Description of SymbolStandard Reference
The requirements foraccreditation and market

CE mark

European conformity

surveillance relating to themarketing of products;
Medical Device Directive &Medical Device Regulation.
The requirements foraccreditation and market

Or

CE mark with Notified
Body Number

European conformity

surveillance relating to themarketing of products;
Medical Device Directive &Medical Device Regulation.

Version 2: Last update 22, Feb. 2024

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