Tag: Fire risks

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  It supersedes BS EN 60601-1:2006, which is to be withdrawn on October 1st, 2014.

Implementation of CENELEC amendment A11:2011 includes the following: Annex ZZ has been replaced by Annexes ZZA, Coverage of Essential Requirements of EC Directives (93/42/EEC), and ZZB, Coverage of Essential Requirements of EC Directives (90/385/EEC).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changes the latest date by which any national standards conflicting with this EN standard have to be withdrawn, making the new due date October 1, 2014.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 EN 1127-1 2011 Edition on Explosive atmospheres – Explosion prevention and protection – Part 1: Basic concepts and methodology affects those certifying to Directive 94/9/EC

BS EN 1127-1 2011 Edition, “Explosive atmospheres – Explosion prevention and protection – Part 1: Basic concepts and methodology,” has just been released.  It is the official English language edition of EN 1127-1:2011.  The administrative process of integrating the new release with the Lists of Harmonized Standards for Directives 94/9/EC and 2006/42/EC is expected to be completed shortly.

EN 1127-1 specifies general design and construction methods to help designers and manufacturers in achieving explosion safety in the design of equipment, protective systems and components at all stages of its use.  It is applicable to any equipment, protective systems and components intended to be used in potentially explosive atmospheres, under atmospheric conditions. These atmospheres can arise from flammable materials processed, used or released by the equipment, protective systems and components or from materials in the vicinity of the equipment, protective systems and components and/or from the materials of construction of the equipment, protective systems and components.

The standard specifies methods for the identification and assessment of hazardous situations leading to explosion and the design and construction measures appropriate for the required safety. This is achieved by risk assessment and risk reduction.

The safety of equipment, protective systems and components can be achieved by eliminating hazards and/or limiting the risk by using a) appropriate design (without using safeguarding); b) safeguarding; c) information for use; d) any other preventive measures.

Measures in accordance with a) (prevention) and b) (protection) against explosions are dealt with in Clause 6, measures according to c) against explosions are dealt with in Clause 7. Measures in accordance with d) are not specified in this European Standard. They are dealt with in EN ISO 12100:2010, Clause 6.

The preventive and protective measures described in EN 1127-1 will not provide the required level of safety unless the equipment, protective systems and components are operated within their intended use and are installed and maintained according to the relevant codes of practice or requirements.

The new BS EN 1127-1:2011 and all BS publications are available from Document Center Inc. through our website, www.document-center.com.  Or if you prefer, you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  The various publications for the EN standards can cause confusion.  If you have any questions about what publications you should be using, please contact us.

New BS EN 71-2 2011 Edition, Safety of toys – Flammability

BS EN 71-2, “Safety of toys.  Flammability,” has just been released as the new 2011 Edition.  It replaces BS EN 71-2:2006+A1:2007, which is now obsolete.  This official English edition specifies the categories of flammable materials which are prohibited in all toys sold in Europe, and requirements concerning flammability of certain toys when they are subjected to a small source of ignition.

The test methods described in Clause 5 are used for the purposes of determining the flammability of toys under the particular test conditions specified. The test results thus obtained cannot be considered as providing an overall indication of the potential fire hazard of toys or materials when subjected to other sources of ignition.

BS EN 71-2:2011 includes general requirements relating to all toys and specific requirements and methods of test relating to the following toys, which are considered as being those presenting the greatest hazard: – toys to be worn on the head: beards, moustaches, wigs, etc. made from hair, pile or material with similar features; masks; hoods, head-dresses, etc.; flowing elements of toys to be worn on the head, but excluding paper novelty hats of the type usually supplied in party crackers; – toy disguise costumes and toys intended to be worn by a child in play; – toys intended to be entered by a child; – soft-filled toys.

NOTE Additional requirements for flammability of electric toys are specified in BS EN 62115.

This standard and all BS documents are available from Document Center Inc. through our website, www.document-center.com.  Or contact us at 650-591-7600, by fax at 650-591-7617, or by email at info@document-center.com.  We’re available from 8 am to 5 pm California time to assist you with your standards needs.

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.