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Eisner Safety Consultants: Qmed Qualified Supplier
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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to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived. [...]

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IEC 60601-1-2:2014 (4th ed.) What is the Impact of this Puzzle on Your Product Design?

This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4th ed. & a discussion of timing of requirements in different world regions. Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory content for this Blog Post.  Thx for your insight Darryl! What is the impact of [...]

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OSHA NRTL’s approved for AAMI ES 60601-1 3rd edition + Amendment 1 (or edition 3.1)

  This post discusses NRTL’s approved for AAMI ES 60601-1 3rd ed. + A1 & can issue NRTL Marks vs which are in process. There has been a lot of activity from OSHA with respect to the NRTL (Nationally Recognized Test Laboratory) program of late for medical device testing.  UL 60601-1 is still an approved [...]

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Can an OSHA NRTL Certify to ANSI/AAMI ES60601-1:2005/(R)2012 with Amendments Yet?

This article discusses OSHA’s release of ANSI/AAMI ES60601-1:2005/(R)2012 + Amendments & timing of @ least 1 NRTL’s authorization to use it. On 27 March 2014 OSHA announced thru a Federal Register Final Notice that they are incorporating new test standards into the list of ‘Appropriate NRTL* Program Test Standards’.  With this announcement they have officially [...]

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IEC 60601 Medical Electrical Equipment Classifications: FAQ’s

IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog.  Why do I need to classify my product for IEC 60601-1, 3rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as noted in sub-clause 6.1 of IEC 60601-1, 3rd ed or 3rd ed. with Amendment 1 [...]