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Eisner Safety Consultants: Qmed Qualified Supplier
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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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CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released

This blog reviews the release of Canadian Standard CAN/CSA C22.2 No. 60601-1:14 & where accessible (Safety Test Agencies vs Health Canada) Recently Released CAN/CSA C22.2 No. 60601-1:14

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TÜV SÜD & Global EMC IEC 60601-1, 3rd ed Seminar

TÜV SÜD Canada & Global EMC will be giving an all day seminar on IEC 60601-1, 3rd ed. on Feb 21, 2014 in the Montreal, Canada area for a very reasonable cost of $100.  This will be on the test requirements and the constructional requirements of the standard and will not be focused on the [...]

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Leo Eisner Track Chair at MD&M West Conf 11-Feb Discuss EN ISO 14971:2012

UBM Canon Communications has graciously asked me to join this year’s MD&M West Conference with the honor of being the track chair for the Risk, Quality & Validation track on Tues 11 Feb 2014.  We have a great line up that day so please come join us.   To kick-off the morning for our track I will [...]

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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, [...]