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

Scrip Regulatory Affairs Article on IEC 60601-1 for US & Canada






11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1″ Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada. [...]

Print This Post Print This Post

IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published






IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1. The technical report tiled IEC TR 60601-4-3:2015 Guidance & interpretation – Considerations of unaddressed safety aspects in the 3rd ed of IEC [...]

Print This Post Print This Post

Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015






Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing. AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”.  This report is available from AAMI at http://my.aami.org/store/SearchResults.aspx?searchterm=62354&searchoption=ALL. This document is identical to the IEC TR 62354:2014 published last September, and gives detailed [...]

Print This Post Print This Post

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 [...]

Print This Post Print This Post

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 [...]