Tag: BS EN 60601-1

BS EN 60601-1 2006 Edition on Medical electrical equipment — General requirements for basic safety and essential performance is now modified by Amendment A11

BS-EN-60601-1, “Medical electrical equipment. General requirements for basic safety and essential performance,” has just been re-released in a new edition and is now available from Document Center Inc.  This British Standard is the UK implementation of EN 60601-1:2006+A11:2011. It is identical to IEC 60601-1:2005.  It supersedes BS EN 60601-1:2006, which is to be withdrawn on October 1st, 2014.

Implementation of CENELEC amendment A11:2011 includes the following: Annex ZZ has been replaced by Annexes ZZA, Coverage of Essential Requirements of EC Directives (93/42/EEC), and ZZB, Coverage of Essential Requirements of EC Directives (90/385/EEC).  The two new Annexes are informative, each providing illumination on how the standard helps to meet the requirements of the directive noted.

Also, BS EN 60601-1:2006+A11:2011 changes the latest date by which any national standards conflicting with this EN standard have to be withdrawn, making the new due date October 1, 2014.

As noted in previous blogs, BS EN 60601-1 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. It is one of our top-sellers here at Document Center and can be ordered on our website, www.document-center.com.  Or order via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here from 6 am to 5 pm Monday through Friday Pacific Time to assist you with all your questions regarding European Standards and Regulations.

 

Document Center’s Top 20 Best Selling Standards for 2011

Yes, it’s the end of the year and what better time to highlight our best selling standards of 2011!  Here’s what Document Center customers wanted this year:

  1. ISO 14155, 2nd Edition and Technical Corrigendum (correction sheet) from 2011, “Clinical investigation of medical devices for human subjects – Good clinical practice”
  2. ISO 19011, 2nd Edition, 2011, “Guidelines for auditing management systems”
  3. AMS 2700, Revision E, “Passivation of Corrosion Resistant Steels”
  4. 21CFR(800-1299), 2011 Edition, “Code of Federal Regulations – Food and Drug Administration Parts 800 through 1299”
  5. BS EN ISO 14971, 2009 Edition with Corrigendum 1 (correction) from 2011, “Medical devices. Application of risk management to medical devices”
  6. ASTM F1980, 2007 R2011 Edition (reapproved in 2011), “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices”
  7. IPC A 610, Revision E from 2010, “Acceptability of Electronic Assemblies”
  8. AS 9100, Revision C from 2011, “Quality Management Systems – Requirements for Aviation, Space & Defense Organizations”
  9. ASME Y14.5, 2009 Edition, “Dimensioning and Tolerancing”
  10. ASQ Z1.4, 2008 Edition, “Sampling Procedures and Tables for Inspection by Attributes”
  11. ASTM E1417, 2011 Edition, “Standard Practice for Liquid Penetrant Testing”
  12. ISTA 2A, 2011 Edition, “Performance Tests for Packaged-Products, Packaged-Products 150 lb (68 kg) or Less”
  13. ISO 9001, 4th Edition, Corrected and reprinted in 2009, “Quality management systems — Requirements”
  14. SOR/98-282, 2011 Edition, “Canadian Medical Devices Regulation”
  15. ASTM D4169, 2009 Edition, “Standard Practice for Performance Testing of Shipping Containers and Systems”
  16. ASTM E1444, 2011 Edition, “Standard Practice for Magnetic Particle Testing”
  17. BS EN 60601-1, 2006 Edition with Corrigendum 1 (correction sheet) from 2011, “Medical electrical equipment. General requirements for safety”
  18. ISO 10993-1, 4th Edition with Technical Corrigendum 1 (correction sheet) from 2011, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
  19. ISO 13485, 2nd Edition with Technical Corrigendum 1 (correction sheet) from 2009, “Medical devices – Quality management systems – Requirements for regulatory purposes”
  20. ASTM A240, 2011a Edition, “Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications”

These documents are all 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) for more information.  We’re happy to help you with all your standards questions and requirements.

Happy New Year!

New Amending Correction has just been released for BS EN 60601-1

BS EN 60601-1:2006, “Medical electrical equipment – General requirements for basic safety and essential performance,” has just been modified by a new Corrigendum 1 correction.  The document is the official English language edition of EN 60601-1.

The corrigendum dated May 31st, 2011, is a consolidated implementation of IEC corrigenda dated in December 2006 and December 2007 (tagged) for the source document IEC 60601-1.   It’s also the  implementation of CENELEC corrigendum March 2010, as well as the  modification of CENELEC Foreword and Annexes ZA and ZZ.

The start and finish of text introduced or altered by IEC corrigendum December 2006 is indicated in the text by one tag. Text altered by IEC corrigendum December 2007 is indicated in the text by another.  There are no clear indications of the location of the modifications to the foreword, the two annexes or the CENELEC Corrigendum.  A review of the previous edition against this one will be necessary.  However, the page count of both the 2006 Edition and this new issue remains constant at 384 pages.

This corrected issue supersedes BS EN 60601-1:1990 and BS EN 60601-1-4:1997 which are declared obsolete and are scheduled for withdrawl on June 1, 2012.  It also supersedes BS EN 60601-1-1:2001 which is withdrawn with the publication of this new revision.

For a copy of the new BS EN 60601-1 or any BS standard, please use our website www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re available to assist you with all your standards requirements.