Tag: BS EN ISO 13485

BS EN ISO 13485 Correction Issued

BS EN ISO 13485 2016 Edition, “Medical devices. Quality management systems. Requirements for regulatory purposes,” has just been reissued with a Corrigendum 1 (correction).  This updated edition is available from Document Center Inc. now.  If you use this publication, please get your corrected copy asap as it does contain changes that will affect your compliance requirements for Europe.

The BS EN ISO 13485 is the official English language edition of the EN ISO 13485.  You will note that other national editions contain the same text for the English edition as does the BS version.  So it is possible to meet your requirements with editions from Sweden, Germany or other jurisdictions.  The English text of the standard remains the same in them all.

The corrections to the BS version center on the preliminary material, that is the forward and the various Annexes.  Since the Annexes provide you with the specific information on what clauses of the standard meet the requirements of the various Directives referenced, they’re essential to effectively implementing the standard.  Other items of note include the official requirement to use the EN edition of the ISO 9001, for example.

For those of you who have already purchased your copy of the BS EN ISO 13485 from Document Center Inc., you can get the corrected edition for a nominal service charge to cover the costs of reprinting the entire document.  For those of you who haven’t gotten a copy yet, you’ll just purchased the corrected 2016 Edition that’s available at our webstore.

You can search for an order standards here at our Document Center website, www.document-center.com.  And here’s the link to go directly to the order page for the BS EN ISO 13485.  If you have questions and would like to talk with our staff, consider giving us a phone call at 650-591-7600 or contacting us by email at info@document-center.com.  We are an authorized distributor of EN Standards in a number of European National editions.  We’ll help you choose the best one for your purposes.  Make Document Center 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.

Correction issued to BS EN ISO 13485:2012 Edition for Medical devices. Quality management systems. Requirements for regulatory purposes

It seems like the 2012 of BS EN ISO 13485,”Medical devices. Quality management systems. Requirements for regulatory purposes,” was just released.  But a few corrections have been found so the consolidated BS EN ISO 13485:2012 with Corrigendum 1 is now available from Document Center Inc.  A Corrigendum is a technical correction sheet and the EN standards are released as interfiled reprints of the original document.

The CENELEC corrigendum is from July 2012, but the integration into the BS Edition is dated 9/30/2012.  There are two corrections:  the title was altered and Table ZC.3 (Relationship with Annex IV of Directive 98/79/EC) was updated.

If you bought your copy of the BS EN ISO 13485:2012 from Document Center Inc., we’ll provide you with a corrected copy for a modest printing fee.  If not, you’ll need to purchase the new copy in its entirety.  You can order the document on our website, www.document-center.com.   Otherwise, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

New BS EN ISO 13485 2012 Edition, Medical devices. Quality management systems. Requirements for regulatory purposes

BSI has just released the new 2012 edition for BS EN ISO 13485, “Medical devices. Quality management systems. Requirements for regulatory purposes,” and it’s available from Document Center Inc. now.

BS EN ISO 13485:2012 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can be used by internal and external parties, including certification bodies which test an organization’s ability to meet both customer and regulatory requirements.

This edition is the UK implementation of EN ISO 13485:2012.  It is identical to ISO 13485:2003, incorporating the corrigendum from August 2009. It supersedes BS EN ISO 13485:2003, which will be withdrawn on August 31, 2012.

The document is now 86 pages in length, compared to the 72 pages of the 2003 Edition republished in 2010 with the 3 corrigenda interfiled.  Changes have been made to the foreword and especially to the annexes, which accounts for the additional material.

It is available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  It’s our 30th year in business — we’ve been supplying companies around the world with standards and services since 1982.  We’d love to help you with your standards requirements as well!