OSHA adding AAMI ES 60601-1 to the ‘List of Appropriate’ NRTL Program Test Standards is discussed in this blog. BIG News!!! News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test
Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ
EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.
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
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
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