AAMI ES60601-1: 2005/A2:2021


Amendment 2, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
Amendment by Association for the Advancement of Medical Instrumentation, 03/01/2022

PDF FormatPDF FormatMulti-User AccessMulti-User AccessPrintablePrintableBookmarksBookmarks


This second amendment to ANSI/AAMI ES60601-1:2005 addresses changes to terminology and references since the main document was finalized in 2005 and first amended in 2012. There are additional updates to clauses to keep current with technology as well as to address questions received since the first amendment was published. The main document and amendments provide requirements for the safety and essential performance for all medical electrical equipment. 

Product Details

ANSI Approved
Number of Pages:
File Size:
1 file , 2.3 MB
This product is unavailable in Russia, Ukraine, Belarus