Eisner Safety Consultants

Eisner Safety Consultants is attending the 74th Annual IEC General Meeting in Seattle Washington thru Oct 16, 2010.  As a US National Committee member of Technical Committee (TC) 62, Subcommittees (SC) 62A & 62D we are attending the committee meetings that will help medical device manufacturer’s better understand the coming & current standards requirements.  We [...]

How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents CDRH is considering for development this year (2011). CDRH plans to update this list every [...]

#FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard http://ht.ly/2oiBH

BS EN 60601-2-43:2010 Med. elec. equip. – Particular rqrts – X-ray equip. for interventional procedures Pub. 31-JUL-10 http://ht.ly/2fSOS

BS EN 60601-1-11:2010 Medical electrical equipment-Collateral standard for use in home healthcare environ Pub 31-JUL-10 http://ht.ly/2fRwW