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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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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 [...]

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When will FDA Issue Guidance Document on AAMI ES 60601-1, 3rd ed. + Amendment 1?

That’s a really good question and the answer is sooner than I would have thought.  Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to know if this time it will truly happen or not.  I would hazard to guess [...]

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Where is EU headed with Proposed Medical Device Regulations by ENVI?

The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of devices.  Note, this issue is not set in stone and you should read some of the [...]

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FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032

The big news in the IEC 60601-1, 3rd ed. world today is the US National Standard that is in the FDA’s Recognized Consensus Standards Lists [Now is ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) - Recognition List #: 031, Recognition # 5-77] has had it’s transition date moved from June 30, 2013 to [...]