Symbol Glossary Definitions

Symbol Glossary Definitions

SYMBOL STANDARD REFERENCE STANDARD TITLE SYMBOL TITLE EXPLANATORY TEXT
SYM-001 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 Manufacturer Indicates the medical device manufacturer.
SYM-002 ISO 15223-1:2021
Reference no. 5.1.2
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements Authorized Representative in the European Community/ European Union Indicates the authorized representative in the European Community/European Union.
SYM-004 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 Date of manufacture Indicates the date when the medical device was manufactured.
SYM-005 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 Use-by date Indicates the date after which the medical device is not to be used.
SYM-006 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 Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified.

Synonyms for “batch code” are “lot number”, “lot code”, and “batch number”.
SYM-007 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 Catalogue number or Catalog number Indicates the manufacturer’s catalogue/catalog number so that the medical device can be identified.
SYM-008 ISO 15223-1:2021
Reference no. 5.1.8
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements Importer Indicates the entity importing the medical device into the locale.
SYM-009 ISO 15223-1:2021
Reference no. 5.1.9
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements Distributor Indicates the entity distributing the medical device into the locale.
SYM-010 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 Temperature limit Indicates the temperature limits to which the medical device can be safely exposed.
SYM-011 ISO 15223-1:2021
Reference no. 5.4.1
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements Biological risks Indicates that there are potential biological risks associated with the medical device.
SYM-012 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 Consult instructions for use or consult electronic instructions for use Indicates the need for the user to consult the instructions for use.
SYM-013 ISO 15223-1:2021
Reference no. 5.5.1
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements In Vitro diagnostic medical device Indicates a medical device intended to be used as an in vitro diagnostic medical device.
SYM-014 N/A N/A Content Indicates the content in the product.
SYM-015 N/A N/A Reagent 1 Indicates Reagent 1 in the product.
SYM-016 N/A N/A Reagent 2 Indicates Reagent 2 in the product.
SYM-017 ISO 15223-1:2021
Reference no. 5.5.3
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements Negative control Indicates a control material that is intended to verify the results in the expected negative range.
SYM-018 ISO 15223-1:2021
Reference no. 5.5.4
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements Positive control Indicates a control material that is intended to verify the results in the expected positive range.
SYM-019 N/A N/A SDS Indicates Safety Data Sheet.
SYM-020 ISO 15223-1:2021
Reference no. 5.5.5
Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements Contains sufficient for number of tests

Indicates the total number of tests that can be performed with the medical device.
SYM-021 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 Unique device identifier Indicates a carrier that contains unique device identifier information.
SYM-022 N/A N/A Global Trade Item Number Indicates that the product has a Global Trade Item Number.
SYM-023 Regulation (EU) 2017/746
Article 18
Annex V
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5th April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU CE marking ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonization legislation
providing for its affixing. (IVDR Article 2, (35)).
SYM-024 N/A N/A Prescription Use Only Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.
SYM-024 N/A N/A Test Kit Number Canadian Registration for Test Kit.

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