Tag: BS EN ISO 15223-1

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!

 

Document Center’s 20 Top Selling Standards of 2012

Yes, it’s time to review Document Center‘s top selling standards of 2012.  Do you use any of these popular items?

  1. BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
  2. BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
  3. ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
  4. BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
  5. ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
  6. AMS 2750, New Revision E, Pyrometry
  7. 21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
  8. ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
  9. SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
  10. IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  11. MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
  12. ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
  13. ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
  14. ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
  15. IPC-A-610, Revision E, Acceptability of Electronic Assemblies
  16. ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
  17. ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
  18. ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
  19. ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
  20. IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies  — tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

BS EN 980 replaced by new release BS EN ISO 15223-1, Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements

For all of you in the medical device field, the BS EN 980 (Official English language edition of EN-980) “Symbols for use in the labelling of medical devices” has been a must-have in your conformance documentation collection.  Now the European standard has been withdrawn and replaced by the new 2012 issue of BS EN ISO 15223-1, “Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements.”  Available at Document Center Inc., the new integrated standard provides consolidated International and European requirements for symbols used in medical device labelling.

The text of ISO 15223-1:2012 was approved by CEN as a EN ISO 15223-1:2012 without any modification.  Use of the standard is a means of conforming to the New Approach Directive 93/42/EEC on medical devices.

In addition to the text of ISO 15223-1, the EN adoption BS EN ISO 15223-1:2012 contains three informative Annexes.  The first is Annex ZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical device.”  The second is Annex ZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices.” And the third is Annex ZC, “Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices.”

Expect to see more adoptions of the ISO 15223-1:2012 across various jurisdictions during the next few months.

All these documents plus a wide variety of other standards used by the Medical Device Industry are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone at +650-591-7600, fax at +650-591-7617 or by email at info@document-center.com.  You may also want to review our other audit and monitoring services for standards that are particularly helpful to organizations who are required to pass conformance audits on a regular basis.