ISO Publishes Third Edition of ISO 15223-1 for Medical Device Labeling



The International Organization of Standardization (ISO) releases the third edition of ISO 15223 Part 1, for medical device labels. This standards update provides the general requirements for medical device labeling, symbols used with the labels, and necessary information to be supplied. 

Description: “ISO 15223-1:2016 identifies requirements for symbols used in medical device labeling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.

ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.”


*Description from the ISO Website.

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