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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 Test Laboratory) program of late for medical device testing.  UL 60601-1 is still an approved [...]

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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 to be granted in late summer.

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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 [...]

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Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1

A Q&A post based on questions in the 25 Nov ‘13 post on OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards

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IEC 60601-1 Definition of Patient Applied Parts – Part 1 of 2

This blog will you understand the definition of Patient Applied Parts for medical electrical equipment under the IEC 60601-1 Standard.  This blog discusses the following points: Definition of APPLIED PART Examples of APPLIED PARTS for specific medical devices Examples of different types of APPLIED PARTS (Type B, BF, CF or & each can be Defibrillator Proof [...]