Welcome to the SafeSource Direct Medical Device Symbols Glossary, designed to help you understand the key icons and terms used on the packaging of our American-made PPE products. At SafeSource Direct, we take pride in manufacturing high-quality personal protective equipment right here in the USA, adhering to the strictest safety and regulatory standards. This guide, based on the ISO 15223-1: 2021 standard, provides clear definitions of the symbols you'll find on our products, ensuring that healthcare professionals and consumers alike can use them with confidence. Explore the list below to familiarize yourself with the symbols and their meanings to ensure safe and effective use of our PPE.

ISO 15223-1 Standard Definitions

SYMBOL

SYMBOL TITLE

DESCRIPTION

STANDARD REFERENCE

STANDARD TITLE

 

Manufacturer

Indicates the medical device manufacturer

ISO 15223-1: 2021


Reference no. 5.1.1

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Do Not Re-use

Indicates the medical device that is intended for one single use only NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”.

ISO 15223-1:2021


Reference no. 5.4.2

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Date of Manufacture

Indicates the date when the medical device was manufactured

ISO 15223-1: 2021


Reference no. 5.1.3

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Use-by Date

Indicates the date after which the medical device is not to be used

ISO 15223-1: 2021


Reference no. 5.1.4

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Batch Code

Indicates the manufacturer’s batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” are “lot number”, “lot code” and “batch number”.

ISO 15223-1: 2021


Reference no. 5.1.5

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Unique Device Identifier

Indicates a carrier that contains unique device identifier information

ISO15223-1: 2021


Reference no. 5.7.10

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Medical Device

Indicates the item is a medical device

ISO 15223- 1:2021


Reference no. 5.7.7

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Catalogue number

Indicates the manufacturer’s catalog number so that the medical device can be identified

ISO 15223-1: 2021


Reference no. 5.1.6

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Model Number

Indicates the model number or type number of a product

ISO 15223-1: 2021


Reference no. 5.1.10

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Consult Instructions for Use or Consult Electronic Instructions for Use

Indicates the need for the user to consult the instructions for use

ISO 15223-1:2021


Reference no. 5.4.3

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Do Not Use if Package is Damaged and Consult Instructions for Use

Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information

ISO 15223-1: 2021


Reference no. 5.2.8

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Non-Sterile

Indicates a medical device that has not been subjected to a sterilization process

ISO 15223-1: 2021


Reference no. 5.2.7

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Keep Away from Sunlight

Indicates a medical device that needs protection from light sources

ISO 15223-1: 2021


Reference no. 5.3.2

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Keep Dry

Indicates a medical device that needs protection from moisture

ISO 15223-1: 2021


Reference no. 5.3.4

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Temperature Limit

Indicates the temperature limits to which the medical device can be safely exposed

ISO 15223-1: 2021


Reference no. 5.3.7

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Humidity limitation

Indicates the range of humidity to which the medical device can be safely exposed

ISO 15223-1: 2021


Reference no. 5.3.8

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements

 

Not Made with or Absence of Natural Rubber Latex

Indicates the absence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device

ISO 15223-1: 2021


Reference #5.4.5
Annex B for negation symbol

Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements