EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

Publication date:   Aug 20, 2010

General information

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

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
2007/47/EC

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 14155-2:2003

NOW

WITHDRAWN
EN ISO 14155-2:2009
99.60 Withdrawal effective
Feb 1, 2011

REVISED BY

WITHDRAWN
EN ISO 14155:2011

Relations

Adopted from ISO 14155-2:2003 IDENTICAL