Eisner Safety Consultants: Qmed Qualified Supplier
Print This Post Print This Post

MDD Harmonized List of Standards Website Moves & Medical Device Sector Page Changes






On 2 Feb 2015 the previous site for the List of Harmonized Standards for the MDD and other Medical Device Directives (AIMDD & IVDD) moved to a new location. The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived. [...]

Print This Post Print This Post

Pre-release of IEC 60601-2-52 1st ed + Amendment 1 – Medical Beds






This post is the early release of IEC 60601-2-52, 1st ed. + Amendment 1 (A1) before being issued as an International Standard (IS).  It is currently available as an FDIS (Final Draft International Standard) for purchase from IEC.  IEC website states: “By purchasing this FDIS now, you will automatically receive, in addition, the final publication.”  [...]

Print This Post Print This Post

EN60601-1:2006 + A1:2013 Has Been Harmonized Under the MDD






This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News About? On 16 May 2014 the Official Journal of the European Union (OJEU) published an [...]

Print This Post Print This Post

IEC 60601-1 PATIENT APPLIED PARTS of MEE – Notes 1, 2, & 3 – Part 2 of 2






In this blog, we continue our discussion on Patient Applied Parts, in Part 2, by explaining the 3 notes associated with the definition of Applied Parts, 3.8 of IEC 60601-1, 3rd ed & ed. 3.1.  We use several figures to explain these critical concepts. If you need help with the IEC 60601 series of Standards, [...]

Print This Post Print This Post

IEC 60601-1 Definition of Patient Applied Parts – Part 1 of 2






This blog will you understand the definition of Patient Applied Parts for medical electrical equipment under the IEC 60601-1 Standard.  This blog discusses the following points: Definition of APPLIED PART Examples of APPLIED PARTS for specific medical devices Examples of different types of APPLIED PARTS (Type B, BF, CF or & each can be Defibrillator Proof [...]