ISO 15223-1:2012, “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements,” has just been released and is now available from Document Center Inc. This second edition cancels and replaces the first edition (ISO 15223-1:2007) which has been technically revised. It also incorporates the amendment ISO 15223-1:2007/Amd.1:2008.
This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008, combining the symbols and requirements of both standards for the first time. There has been a steady convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the previous differences between the standards resolved. Users of EN 980, “Symbols for use in the labelling of medical devices,” will want to upgrade to EN ISO 15223-1, 2012 Edition, as the EN 980 is now withdrawn and obsolete.
ISO 15223-1 represents a significant advance in the safe and effective use of symbols to transcend language, giving manufacturers, regulators and others a single set of global symbols for use with medical devices. The standard 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 presented may be used on the medical device itself, on its packaging or in the associated documentation.
All current ISO standards and many of the obsolete revisions are available from Document Center Inc. at our website, www.document-center.com. They are available in paper format or in the United States as pdf format as well. You may want to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We are here to assist you with any standards-related questions or requirements.
Can you please advise whether EN ISO 15223-1 is an EU harmonized standard? I do not see it on the list from the EU Commission but the most recent list is dated January 2013. I have not been able to identify a more recent listing.
Thank you in advance for your assistance,
Linda Charles
Hi Linda:
And thanks so much for asking.
You are quite correct. There are 3 directives that apply to medical devices: 90/385/EEC (Active Implantable Medical Devices), 98/79/EC (In vitro diagnostic medical devices), and 93/42/EEC (Medical devices). The EN ISO 15223-1 is not on the harmonized standards listing for any of these 3.
However, it is adopted by the European Union for use as a European Standard.
Hope this helps!
Regards,
Claudia