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99.60 Withdrawal effective Feb 1, 2011
CEN
CEN/TC 258 Clinical investigation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
Withdrawn
1 Scope
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
Legislation related to this standard
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
WITHDRAWN
EN ISO 14155-2:2003
WITHDRAWN
EN ISO 14155-2:2009
99.60
Withdrawal effective
Feb 1, 2011
WITHDRAWN
EN ISO 14155:2011