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IEC60601-1 3rd ed. Amendment 1

CAN/CSA C22.2 No. 60601 Standard Changes

Reminder post – withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN/CSA-C22.2 No. 60601-1:14 was recently published        

leoeisner May 28, 2014 Uncategorized Read more

CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released

This blog reviews the release of Canadian Standard CAN/CSA C22.2 No. 60601-1:14 & where accessible (Safety Test Agencies vs Health Canada) Recently Released CAN/CSA C22.2 No. 60601-1:14

leoeisner April 7, 2014 Uncategorized Read more

South Korea MFDS Amends it’s Medical Devices Act & Will Require IEC 60601-1, 3rd ed + Amendments

There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.

leoeisner July 18, 2013 Uncategorized Read more

Publication of IEC 60601-1, 3rd ed. Amendment 1 Imminent

It has been a bit more than 4 years since the A1 project was approved and initiated.  The vote on Amendment 1 (A1) of IEC 60601-1, third edition project ended on 2 July 2012 and it was a resounding unanimous positive

leoeisner July 11, 2012 Uncategorized Read more

DRAFT results implementation of 3Ed (EN60601 series) for CE marking

This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN

leoeisner October 6, 2011 Uncategorized Read more
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Recent Industry News

  • IEC 60601, 4th Edition: What’s Changing and How to Prepare
    February 28, 2026
  • Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards
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  • Medical Device Compliance & Certification Summit – Why It Matters?
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Recent Industry News

  • IEC 60601, 4th Edition: What’s Changing and How to Prepare
    February 28, 2026
  • Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards
    January 4, 2026
  • Medical Device Compliance & Certification Summit – Why It Matters?
    December 23, 2025
  • What’s NASA & Star Trek have to do with IEC 60601?
    November 29, 2025
  • From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast
    October 19, 2025

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