BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice

BS EN ISO 14155:2011

Clinical investigation of medical devices for human subjects. Good clinical practice

Status : Superseded, Withdrawn   Published : February 2011 Replaced By : BS EN ISO 14155:2020

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BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice

BS EN ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in BS EN ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.

This International Standard specifies general requirements intended to:

  • Protect the rights, safety and well-being of human subjects
  • Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
  • Define the responsibilities of the sponsor and principal investigator
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.



Standard NumberBS EN ISO 14155:2011
TitleClinical investigation of medical devices for human subjects. Good clinical practice
StatusSuperseded, Withdrawn
Publication Date28 February 2011
Withdrawn Date19 August 2020
Normative References(Required to achieve compliance to this standard)ISO 14971:2007
Informative References(Provided for Information)ISO 10993, EN 1041, 90/385/EEC, ISO 15223-1, 93/42/EEC, ISO 13485:2003
Replaced ByBS EN ISO 14155:2020
ReplacesBS EN ISO 14155-2:2009, BS EN ISO 14155-1:2009
International RelationshipsEN ISO 14155 Corr 1 (07/11) IS,ISO 14155:2011/Cor 1:2011
Amended ByCorrigendum, September 2011
DescriptorsPeople, Performance testing, Risk assessment, Equipment safety, Research methods, Clinical investigation instruments, Patients, Safety measures, Documents, Clinical testing, Performance, Experimental data, Medical equipment, Diagnosis (medical)
ICS11.100.20
Title in FrenchInvestigation clinique des dispositifs médicaux pour sujets humains. Bonnes pratiques cliniques
Title in GermanKlinische Prüfung von Medizinprodukten an Menschen. Gute klinische Praxis
CommitteeCH/194
ISBN978 0 580 76007 5
PublisherBSI
FormatA4
DeliveryYes
Pages70
File Size1.454 MB
Price£254.00


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