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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

leoeisner January 7, 2015 Uncategorized Read more

Several Test Labs Awaiting Approval for AAMI ES 60601-1, ed. 3.1 under OSHA NRTL Program

Several NRTLs, who are currently recognized for UL 60601-1, have applied to OSHA to add ANSI AAMI ES60601 + Amendment 1 to their scope of recognition.  OSHA is currently reviewing these applications and anticipates the final recognition for these NRTLs

leoeisner June 30, 2014 Uncategorized Read more

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

leoeisner April 15, 2014 Uncategorized Read more

OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards

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

leoeisner November 25, 2013 Uncategorized Read more

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  Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to

leoeisner October 19, 2013 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
    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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510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC60601-1 IEC 60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

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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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