News on the harmonized standard ISO 15223.

News on the harmonized standard ISO 15223.

"Medical devices - Symbols, markings and information to be used in the labelling of medical devices".

DIN EN ISO 15223 specifies the requirements for symbols to be used on medical device labels to provide information on the safe and effective use of medical devices.

There are currently two changes affecting the DIN EN ISO 15223 standard.

A draft of DIN EN ISO 15223-1/A1:2019-11 has been available since November 2019. The amendment concerns the annexes ZD and ZE. It describes the relationships between the standard and the essential safety and performance requirements of the new MDR and IVDR regulations.

In parallel, the draft of the fourth edition of ISO 15223-1 was put to the vote at international level in February of this year. This will continue until 14 May 2020.

Here are the most important changes in the fourth edition:

  • 20 new validated symbols are added
  • From the standards ISO 7000, 7001 and IEC 60417 5 more symbols are added
  • The defined term "labelling" is deleted.
  • Additionally defined terms from other standards (ISO 20417, ISO 13485 and ISO 14971) are included
  • The informative appendix is expanded with examples
  • Information on European regulations is included in informative notes.

Some of the new symbols might look like the following: (no guarantee, as no final version of 15223-1 is available yet).

Medical device (MD)Medical_device
Sterilized by vapour phase hydrogen peroxideSterile_vh202
Contains a medicinal substanceMedical_substance
Contains biological material of animal originBio_animal
Contains biological material of human originBio_human
Indication of a modification to the original packaging configuration of the medical device, e.g. repackaging of a multipack to single unitsPacking
Unique Device Identification informationUdi
Why this standard is important.

For manufacturers and other organisations in the medical device supply chain, the symbols standard is of great importance, as it is a regulatory requirement that medical devices are labelled and supplied with specific information. This information is necessary to ensure proper and safe use. It may be placed on the medical device itself, as part of the packaging or included in other accompanying information.
Compared to textual information, pictorial symbols have the advantage of being universally and internationally applicable. The standardisation of symbols ensures that there is no multiple development of symbols for the same information. This simplifies the use for manufacturers on the one hand and makes it much easier for users to understand on the other.

A little anecdote at the end.

In 1995, the company Olympus had applied for the letter combination MD as a word mark for medical and surgical endoscopes. This word mark would conflict with the symbol MD for certain products and cause problems. In March of this year, the owner of the trademark applied for cancellation, thus giving preference to the symbol MD.

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Persons to the article.

Anastasia Wolf

Principal Project Consultant

Anastasia Wolf studied Biopharmaceutical Technology at the Technische Hochschule Mittelhessen in Giessen and graduated with a Bachelor of Science in 2015.
Ms. Wolf worked for a global player in in-vitro diagnostics and was Head of Technical Documentation Regulatory Affairs. She has knowledge of technical documentation, the implementation of international approvals, IEC 62304 medical device software, conformity assessments and data management. Ms. Wolf rounds off her profile with her excellent language skills in German, Russian and English.
Anastasia Wolf supports Entourage as Principal Project Consultant.

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