Key Changes in the Labeling Standard ISO 15223-1: 2021 | HCLTech

Key Changes in the Labeling standard ISO 15223-1: 2021

Medical device manufacturers and others in the supply chain must provide specific information on the medical device itself, as part of the packaging, or in the accompanying information. For simplicity and to avoid translation of text, this information can be provided as symbols that have a specific meaning. The 4th edition of ISO 15223-1 standard introduces twenty-five new symbols which aligned with European (MDR & IVDR) and USFDA Regulations.

This new standard describes more about individual graphical representations which could help manufacturers in a better way of interpretation and practicing. This standard is intended to be used by manufacturers of medical devices who market products in countries where there are specific language requirements. 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. Download whitepaper to continue reading.

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