2022/09/12

Obligation on icons and symbols to display for manufacturers of medical devices

EN ISO 15223-1:2021 has been updated and replace ISO 15223-1:2016 with the aim to improve definitions and descriptions through new symbols for comply with various regulatory requirements.

These symbols in the standard that the manufacturer must supply in order to deliver essential and comprehensive information on medical devices. Such symbols can be used on the medical device itself, on its packaging, or in the accompanying information.

Compare 2021 version and 2016 version:

Added new references: ISO 7000, ISO14971, ISO 13485 and ISO 20417.
Added new symbols.
Deleted the term “labelling”
Included the definition term from ISO 20417, ISO 13485 and ISO14971
Added example in Appendix A.
Included the information about European regulations.

Here we have organized the symbols with modify in 2021 version:

Symbols	Modify content
	1. Delete the definition of manufacturer. 2. Regulation reference 2017/745 and 2017/746.
	Added Note: if authorized representative, importer, distributor, translation or repackaging are the same responsible entity, the name and address don’t need to repeat.
	Added Restrictions of use: this symbol cannot combine with symbol 5.1.11 with a date of manufacture.
	Added Restrictions of use: 1. This symbol is only be accompanied by a sterile symbol (5.2.1 to 52.5 or 5.2.10) 2. This symbol is not to be used on reusable medical devices that are intended to be sterilized between uses.
	Updated Title, description and Note: 1. Title and description: consult instruction for use. 2. NOTE: the recommendation does apply for products that don’t have instructions for us.
	Updated Title: Title: consult instruction for use.
	Updated description: Caution is necessary when operating the device or control close to where the symbol is placed, or current situation needs operator awareness or action in order to avoid undesirable consequences.

New symbols:

sterillized using vaporized hydrogen peroxide.	contains biological material of human origin.
contains human blood or plasma derivatives.	contains biological material of animal origin.
contains nano materials.	contains a medicinal substance.
Single patient multiple use	contains hazardous substances.
importer	single sterile barrier system.
distributor	Double sterile barrier system.
model number	single sterile barrier system with protective packaging inside.
country of manufacture	single sterile barrier system with protective packaging outside.