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2013-12-23
20131223 Safety Information
American Electric Medical regulations ANSI / AAMI ES60601-1 Update Bulletin.
U.S. FDA announced since January 1, 2014 submittal of medical products in August this
year, is required by ANSI / AAMI ES60601-1: 2005 / (R) 2012 and A1: 2012, C1: 2009 / (R)
2012 and A2: 2010 / (R) 2012, the regulations correspond to IEC 60601-1 Edition 3.1 with
Am1 dated 2012-08 safety standards, also known as medical Third Edition Amendment 1.
Because of the differences between the version of the third edition of the medical project to
be reassessed manufacturers can be divided into three categories outlined below:
- The new testing requirements: If Legibility of markings (labels wipe test)
- Re-evaluation of the structure: If Clearance before Fuse and under Fuse
(L and N distances Fuse ago)
- Re-do the risk assessment report: section 7.3.7 as assessment methods for
Supply Terminals.
The following is the FDA requirements for submittal version Message: Related Content
indicate the start of next year to implement versions of recognition # 5-77 (3rd + amd1)
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=31189)
U.S. FDA announced since January 1, 2014 submittal of medical products in August this
year, is required by ANSI / AAMI ES60601-1: 2005 / (R) 2012 and A1: 2012, C1: 2009 / (R)
2012 and A2: 2010 / (R) 2012, the regulations correspond to IEC 60601-1 Edition 3.1 with
Am1 dated 2012-08 safety standards, also known as medical Third Edition Amendment 1.
Because of the differences between the version of the third edition of the medical project to
be reassessed manufacturers can be divided into three categories outlined below:
- The new testing requirements: If Legibility of markings (labels wipe test)
- Re-evaluation of the structure: If Clearance before Fuse and under Fuse
(L and N distances Fuse ago)
- Re-do the risk assessment report: section 7.3.7 as assessment methods for
Supply Terminals.
The following is the FDA requirements for submittal version Message: Related Content
indicate the start of next year to implement versions of recognition # 5-77 (3rd + amd1)
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=31189)
