Tag: Electrical insulation

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  It supersedes BS EN 60601-1:2006, which is to be withdrawn on October 1st, 2014.

Implementation of CENELEC amendment A11:2011 includes the following: Annex ZZ has been replaced by Annexes ZZA, Coverage of Essential Requirements of EC Directives (93/42/EEC), and ZZB, Coverage of Essential Requirements of EC Directives (90/385/EEC).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changes the latest date by which any national standards conflicting with this EN standard have to be withdrawn, making the new due date October 1, 2014.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.

 

New BS EN 397 2012 Edition on Industrial Safety Helmets

EN 397, ” Industrial Safety Helmets,” was released in a new revision recently and the official English language edition, BS EN 397:2012, is now available from Document Center Inc.   This European Standard specifies physical and performance requirements, methods of test, and marking requirements for industrial safety helmets.

The mandatory requirements of BS EN 397 apply to helmets for general use in industry in the European Union as mandated by 89/686/EEC for personal protective equipment. Additional optional performance requirements are included to apply only where specifically claimed by the helmet manufacturer.

Industrial safety helmets (also known as headgear) are intended primarily to provide protection to the wearer against falling objects to avoid brain injury and skull fracture.

EN 397:2012 is written by Technical Committee CEN/TC 158 on “Head protection.”  Countries in Europe are expected adopt it as a national standard, either by publication of an identical text or by endorsement, by July 2012, as well as withdrawing conflicting national standards at the same time.

Since EN standards are not published as stand-alone documents, they are available from Document Center  in the many adoptions from the various countries in Europe.  Normally we suggest using the official English language editions, the BS EN documents.  You’ll find them on our website, www.document-center.com.  Please feel free to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) should you have questions or prefer to order off-line.

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.

BS EN 60601-1, Medical electrical equipment, General requirements for basic safety and essential performance, one of the essential Medical Device Standards

BS EN 60601-1:2006 is one of the essential standards to meet the requirements of the Medical Device Directive for sales of Medical Devices in the European Union.  Entitled “Medical electrical equipment. General requirements for basic safety and essential performance,” the standard is identical in content to the IEC 60601-1 Edition 3.0 from 2005.

BS EN 60601-1 is for intended for use by manufacturers, regulation bodies, independent certification bodies and professional users and beneficiaries of medical electrical equipment.

The standard applies to medical electrical equipment intended to be used in the diagnosis, treatment, or monitoring of a patient.  It focuses on the basic safety and essential performance of medical electrical equipment and medical electrical systems.

The standard is one of a group of standards in the 60601 series.  For a complete listing of the IEC 60601 series documents, here is our Document Center page with the complete listing – http://www.document-center.com/iec_60601.cfm.

And here is a link to our page on all the documents that are part of the harmonized standards list for the Medical Device Directive.

You’ll find both pages useful in identifying the documents you need in order to meet Medical Device regulations globally.  The standards are all available from Document Center Inc. on our website, www.document-center.com.  Or call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.com).  Your questions and comments are always welcome.