Advanced IEC 60601 Compliance
Event Details
This course agenda has been put together based on feedback from past participants for additional practice performing conformity assessment activities. To satisfy this need, OBCM is offering a special 1
Event Details
This course agenda has been put together based on feedback from past participants for additional practice performing conformity assessment activities. To satisfy this need, OBCM is offering a special 1 week of training focused on how to perform testing and fill out test reports, including looking at guidance and reference docs, such as IEC TR 62354:2014 and IECEE CB interpretations.
We’ll include 3 equipment types:
- home health care environment equipment (something where patient is operator to promote hair growth),
- emergency medical services equipment (chest compression device), and
- hospital type equipment, with particular (probably endoscopic or HF equipment)
The applicable medical electrical equipment safety standards and IECEE Test Report Forms we’ll use:
- IEC 60601-:2005 + A1:2012, general basic safety and essential performance
- National differences, (test report form US_ND_IEC60601_1G)
- IEC 60601-1-6:2010 + A1:2013, usability engineering
- IEC 62366:2007 + A1:2014 (or IEC 62366-1:2015), usability engineering
- IEC 62304:2006 + A1:2015, software
- IEC 60601-1-11:2015, home healthcare environment
- IEC 60601-1-12:2014, emergency medical services environment
- Either IEC 60601-2-2:2009 or IEC 60601-2-18:2009
more
Time
October 22, 2018 - October 26, 2018 (All Day) Eastern(GMT-05:00)
Location
The Establishment Restaurant
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