Tag: Medical devices – Symbols to be used with medical device labels

EN ISO 15223-1 Updated

EN ISO 15223-1, “Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements,” has been revised.  The new 2016 Edition adopts the ISO 15223-1 3rd Edition from November.  While it has been published, the adoption as a “harmonized” EN standard has not been formally published in the Official Journal.  The standard is available from Document Center Inc. now.

The new 2016 Edition of EN ISO 15223-1 is intended to replace the previous 2012 Edition (with the correction sheet) from 2012.  It will be adopted and published in national editions by each country in Europe, according to each country’s protocols.  The English, French and German language editions are “official.”  That is, the translations occur at the regional level and so are identical no matter which country publishes them.  Any other language edition can be generated by a member country provided they notify CEN, the governing body for these types of standards.  Member nations have until May 2017 to complete the administrative adoption process for this new update.

You’ll remember that the EN adoptions of the ISO 15223-1 contain the 3 Annexes (ZA, ZB, and ZC).  You’ll use these annexes to map the requirements of the standard to the dictates of the 3 medical device directives.  Since the publication is an adoption, the changes to the content of the standard are of course identical to those of the ISO 15223-1 2016 Edition.

I often get questions about transition periods and I have been asked about this already for the EN ISO 15223-1.  We will not have a firm deadline for transition until after the publication in the Official Journal has been made.  At that time, the new 2016 Edition will appear in the 3 Harmonized Lists for the medical device directives.  You’ll use the “cessation of presumption of conformity” date for your migration planning.  Your transition to the new edition will need to be completed by this date.

Another issue with purchasing the EN ISO 15223-1 is the choice of national edition.  We have a couple of options for you here at Document Center.  For the official English language edition, choose the BS EN ISO 15223-1.  This edition is available in paper format only.  Here is a direct link to the order page for the BS EN ISO 15223-1.  Another great option is the SS EN ISO 15223-1.  This is the Swedish edition, available in English which, as I mentioned above, is exactly the same as the BS text.  The document is available in paper format, for pdf download, and as part of our enterprise solution Standards Online.  Here is a link to the order page for the SS EN ISO 15223-1.

Of course, you can search for and order standards from our 1 million plus collection at our webstore, www.document-center.com.  Or get in touch with our knowledgeable staff by phone (650-591-7600) or email (info@document-center.com) with your questions or orders.  We have been working with standards since 1982.  Make us your Standards Experts!

 

New ISO 15223-1 2012 Edition, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements, replaces EN 980

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.