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

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thr4shvnem

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.

- Partner Content -

Pulse Amplifier Definitions and Terminology

This application note serves as a comprehensive resource, defining key terms like duty cycle, pulse rate, rise/fall time, and pulse width, as well as discussing pulse on/off ratio, RF delay, jitter, and stability.

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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