This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbol s used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.

Learn the Importance of Medical Device Symbols for Labeling. Follow ISO 15223-1 for Clear, Safe, and Compliant Labeling. EU MDR, FDA & CDSCO Labeling Regulation.

ISO 15223-1 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied 5.3.4 Keep dry Indicates a medical device that needs to be protected from moisture. *Approved symbols currently awaiting ISO harmonization are denoted with an asterisk in the Ref # column.

Symbols to be used on labelling (ISO 15223) • Introduces some new symbols • Updated text for other symbols. Safety Sign (ISO 7010) Symbol (ISO 15223)

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. ... Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1 ...

Standard: ISO 15223-1, Medical Devices - Symbols 5.3.2 Keep away from sunlight Indicates a medical device that needs protection from light sources. 5.2.8 Do not use if package is damaged.

ISO 15223-1:2016/ISO 15223-1:2021 – Medical device - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements Symbol Symbol Title Symbol Description Standard Reference Manufacturer Indicates the medical device manufacturer 5.1.1 Authorized representative in the European Community/ European Union

These symbols allow for a consistent portrayal of information. It can also be used by consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities.

Aug 22, 2024 · The standard ISO 15223-1, regulates the symbols that manufacturers are permitted to/must use for labeling medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of relatively few standards under the MDR and added it to the list of harmonized standards .

As per Annex I of the EU MDR regulation, manufacturers have to indicate on the device label that the product is a medical device. Hence the “MD” symbol will be of great help for someone selling their products in the EU and other jurisdictions that recognize CE marking.