BS EN 1041:2008+A1:2013現行
Information Supplied By The Manufacturer Of Medical Devices
出版：British Standards Institution
專家解讀視頻
Describes requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices.
Supersedes 93/502178 DC. (07/2005) Supersedes 06/30123163 DC. (09/2008) 2008 Edition is still active & will be withdrawn on 31-03-2014. 2008 Edition Re-Issued in October 2013 & incorporates AMD 1 2013. (10/2013)
ONORM EN 1041:2013 - Identical
SN EN 1041:2008 - Identical
NEN EN 1041:2008 - Identical
NBN EN 1041:2008 - Identical
UNE EN 1041:2009 - Identical
UNI EN 1041:2000 - Identical
NF EN 1041:2008 - Identical
