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DRDDO
Dear All
have anyone heard about BS EN ISO 14971:2009?
What differance for ISO 14971:2007
DRDDO
have anyone heard about BS EN ISO 14971:2009?
What differance for ISO 14971:2007
DRDDO
Wow!, it is then time now to buy the new std.
On BSI website I found this detail:
"BS EN ISO 14971 Medical devices. Application of risk management to medical devices has been revised and now contains three additional informative annexes, to ensure conformity with a means of conforming to the Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)."
and
"BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007, which has been withdrawn"
Thanks for sharing!
Alberto
Wow!, it is then time now to buy the new std.
On BSI website I found this detail:
"BS EN ISO 14971 Medical devices. Application of risk management to medical devices has been revised and now contains three additional informative annexes, to ensure conformity with a means of conforming to the Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)."
and
"BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007, which has been withdrawn"
Thanks for sharing!
Alberto
Additional
Bottom of page 3 of new standard.
Endorsement notice
The text of ISO 14971:2007, Corrected version 2007-10-01 has been approved by CEN as EN ISO 14971:2009 without any modification.
Money for old rope!
this standard was not harmonized yet -
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html
Date of cessation of presumption of conformity of superseded ISO 14971:2000 is March 31, 2010
The revised published standard EN ISO 14971:2009 is expected to update in Official Journal of the European Union (OJ). Refer herethis standard was not harmonized yet -
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html
Date of cessation of presumption of conformity of superseded ISO 14971:2000 is March 31, 2010