BS EN ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects. Clinical investigation plans – BSI British Standards

BS EN ISO 14155-2:2003

Clinical investigation of medical devices for human subjects. Clinical investigation plans

Status : Revised, Withdrawn   Published : May 2003 Replaced By : BS EN ISO 14155-2:2009

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Clinical investigation of medical devices for human subjects - Part 2:  Clinical investigation plans

BS EN ISO 14155-2 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 optimizing the scientific validity and
reproducibility of the results of a clinical investigation. This standard does not apply to in vitro diagnostic medical devices.

ISBN: 0 580 41910 X




Standard NumberBS EN ISO 14155-2:2003
TitleClinical investigation of medical devices for human subjects. Clinical investigation plans
StatusRevised, Withdrawn
Publication Date27 May 2003
Withdrawn Date31 January 2010
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN ISO 14155-2:2009
International RelationshipsEN ISO 14155-2:2003,ISO 14155-2:2003
Draft Superseded By01/562358 DC
DescriptorsMedical equipment, Clinical testing, People, Clinical investigation instruments, Diagnosis (medical), Documents, Reproducibility, Experimental data, Research methods
ICS11.040.01
11.100.20
Title in FrenchInvestigation clinique des dispositifs medicaux sur les sujets humains. Plan d'investigation clinique
Title in GermanKlinische Pruefung von Medizinprodukten an Menschen. Klinische Pruefplaene
CommitteeCH/194
ISBN0 580 41910 X
PublisherBSI
FormatA4
DeliveryNo
Pages18
File Size303.6 KB
Price£130.00


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