BS EN ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects. General requirements – BSI British Standards

BS EN ISO 14155-1:2003

Clinical investigation of medical devices for human subjects. General requirements

Status : Revised, Withdrawn   Published : March 2003 Replaced By : BS EN ISO 14155-1:2009

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Clinical investigation of medical devices for human subjects - Part 1: General requirements

This part of ISO 14155 defines procedures for conducting and performing clinical investigations of medical devices. It specifies general requirements intended to:

  • protect human subjects
  • ensure the scientific conduct of the clinical investigation
  • assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.

This International Standard

a) specifies requirements for conducting a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device

b) specifies requirements for the organization, conducting, monitoring, data collection and documentation of the clinical investigation of a medical device

c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.

This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.

ISBN: 0 580 41393 4 




Standard NumberBS EN ISO 14155-1:2003
TitleClinical investigation of medical devices for human subjects. General requirements
StatusRevised, Withdrawn
Publication Date12 March 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Withdrawn Date31 January 2010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 14155-1:2009
ReplacesBS EN 540:1993
International RelationshipsEN ISO 14155-1 (ISO 14155-1:20,ISO 3272-1:2003/Cor 1:2009
Amended ByAMD 14481
Corrigendum, May 2003
DescriptorsPeople, Safety measures, Performance, Equipment safety, Patients, Clinical testing, Medical equipment, Documents, Risk assessment, Performance testing
ICS01.100.01
11.040.01
11.100.20
37.080
Title in FrenchInvestigation clinique des dispositifs medicaux pour sujets humains. Exigences generales
Title in GermanKlinische Pruefung von Medizinprodukten an Menschen. Allgemeine Anforderungen
CommitteeCH/194
ISBN0 580 41393 4
PublisherBSI
FormatA4
DeliveryNo
Pages34
File Size368 KB
Price£214.00


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