New edition of ISO 15223-1: 2021

In recent days, the European Commission informed us about the harmonization of the first standards with regulations 2017/745 and 2017/746. Information on the new edition of ISO 15223-1 – Medical devices – Symbols to be used on medical device labels, labeling and information provided with them – Part 1: General requirements

As it is commonly known, the information provided on medical devices must be correctly understood by every actor in the supply chain, regardless of the language they use. For this reason, a number of & nbsp; internationally agreed graphic symbols. The ISO 15223-1 standard is a globally accepted document that applies to symbols used in a wide variety of medical devices, both on their packaging and in the accompanying information. The last update was to improve the definitions and descriptions and to add new symbols to accommodate different legal requirements.

The standard is intended to be used by manufacturers / manufacturers of medical devices who market their products in other countries to ensure consistency and eliminate possible ambiguities in the presentation of information on packaging and instructions for use. It is also useful for users of such products as it helps to understand many issues related to a given product.

ISO 15223-1 was developed by the ISO ISO / TC 210 technical committee. So far the standard is available in the shop ISO Store. CeCert provides a wide range of services related to medical devices. Check them out in offer .

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