Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · ISO and IEC standards for MedTech and pharma

ISO 15223-1

Also known as: ISO 15223-1:2021, EN ISO 15223-1:2021, Medical device symbols

ISO 15223-1 is the international standard that specifies symbols for expressing information supplied by the manufacturer of a medical device, such as on labels and in instructions for use. Each symbol comes with a title and a description of its meaning and requirements for its use.

  • Standards
  • MDR
  • IVDR
  • Technical documentation

In one sentence

ISO 15223-1:2021 specifies symbols for medical device labels and IFUs, such as manufacturer, use-by date, batch code, sterile and consult IFU.

Example

A manufacturer of sterile single-use syringes uses ISO 15223-1 symbols for manufacturer, date of manufacture, use-by date, batch code, sterilization method, do not reuse and medical device, and explains them in the instructions for use.

How it applies

  • Legal hook: Chapter III of Annex I MDR and IVDR allows information on the label to be given by symbols. Where symbols are used, they should conform to harmonized standards or common specifications; otherwise they must be described in the documentation supplied with the device.
  • Content: Symbols for the manufacturer, dates, batch and serial numbers, sterility and sterilization method, storage and handling, safe use (for example do not reuse, consult instructions for use) and IVD-specific information.
  • 2021 edition: The edition added symbols aligned with the MDR and IVDR, including symbols for medical device, importer, distributor, authorized representative and UDI carriers.
  • Limits: A symbol replaces text only where its meaning is established for the user. Safety-related messages may still need words; see warning message. Safety signs follow ISO 7010, not ISO 15223-1; see safety sign.
  • Technical documentation: Record the edition used, explain the symbols in the instructions for use or another document supplied with the device, and keep label artwork under document control.

ISO 15223-1 vs. ISO 20417

ISO 20417 says what information the manufacturer must supply and where. ISO 15223-1 says how some of that information can be expressed by a symbol. A label is designed with ISO 20417 first; ISO 15223-1 then supplies the graphic form.

By knowledge.aitechdoc.world · Published September 25, 2026 · Last reviewed

Source: ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Definitions follow the cited standards and specifications. Where a source is a copyrighted publication, such as an ISO, IEC or EN standard, the definition is a close paraphrase, not a verbatim quotation, so as not to infringe copyright. We recommend reading the original publication. The sections “How it applies” are editorial commentary by AI TechDoc Knowledge and are not part of any standard.

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