Sign-up to our Newsletter

Loading...Loading...


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

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 [...]

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 [...]

Print This Post Print This Post

IEC 60601-1-2, 4th ed. (Electromagnetic disturbances in M.E.E. Environment) recently published

The fourth edition of IEC 60601-1-2 was published on 25 February 2014.  It constitutes a significant change in the standard from the third edition of the standard which was published back in 2007.

Print This Post Print This Post

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  Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to know if this time it will truly happen or not.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 [...]

Print This Post Print This Post

What is the Scope of IEC 60601-1:2005 (3rd edition)?

This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product.  Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery operated [...]