BS EN ISO 14155-2:2009 - Clinical investigation of medical devices for human subjects. Clinical investigation plans – BSI British Standards

BS EN ISO 14155-2:2009

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

Status : Superseded, Withdrawn   Published : January 2010 Replaced By : BS EN ISO 14155:2011

WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001


BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects. Clinical investigation plans

This standard is the second part of BS EN ISO 14155 "Clinical investigation of medical devices for human subjects", and should be read in conjunction with that standard.

Part 2 of BS EN ISO 14155 is intended to assist manufacturers, sponsors, monitors and clinical investigators in the design and conduct of clinical investigations. It is also written to assist regulatory bodies and ethics committees in their roles of reviewing Clinical Investigation Plans (CIP). The CIP is a framework within which appropriate experience, insight, judgement, qualification and education need to be applied. The scientific rigour of a CIP can be verified and possibly improved by an independent review of the CIP.

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 optimising the scientific validity and reproducibility of the results of a clinical investigation.

BS EN ISO 14155-2 does not apply to in vitro diagnostic medical devices.

Contents of BS EN ISO 14155-2 include:

  • Scope
  • Normative references
  • Terms and definitions
  • Requirements
  • Clinical Investigation Plan (CIP)
  • General information
  • Identification of the clinical investigation plan
  • Clinical investigators, principal clinical investigator, co-ordinating clinical investigator, investigation centres/site(s)
  • Sponsor
  • Monitoring arrangements
  • Data and quality management
  • An overall synopsis of the clinical investigation
  • Approval and agreement to the clinical investigation plan
  • Identification and description of the medical device to be investigated
  • Preliminary investigations and justification of the study
  • Literature review
  • Previous clinical experience
  • Device risk analysis and risk assessment
  • Objectives of the clinical investigation
  • Design of the clinical investigation
  • Statistical considerations
  • Deviations from the clinical investigation plan
  • Amendments to the clinical investigation plan
  • Adverse events and adverse device effects
  • Early termination or suspension of the investigation
  • Publication policy
  • Case Report Forms
  • Bibliography

BS EN ISO 14155-2:2009 replaces BS EN ISO 14155-2:2003 which has been withdrawn.




Standard NumberBS EN ISO 14155-2:2009
TitleClinical investigation of medical devices for human subjects. Clinical investigation plans
StatusSuperseded, Withdrawn
Publication Date31 January 2010
Withdrawn Date28 February 2011
Normative References(Required to achieve compliance to this standard)EN ISO 14155-1:2003, ISO 14155-1:2001
Informative References(Provided for Information)EN ISO 14971, EN ISO 10993, 93/42/EEC, 90/385/EEC
Replaced ByBS EN ISO 14155:2011
ReplacesBS EN ISO 14155-2:2003
International RelationshipsEN ISO 14155-2:2009,ISO 14155-2:2003
DescriptorsMedical equipment, Clinical testing, People, Clinical investigation instruments, Diagnosis (medical), Documents, Reproducibility, Experimental data, Research methods
ICS11.100.20
Title in FrenchInvestigation clinique des dispositifs médicaux pour sujets humains. Plans d'investigation clinique
Title in GermanKlinische Prüfung von Medizinprodukten an Menschen. Klinische Prüfpläne
CommitteeCH/194
ISBN978 0 580 69011 2
PublisherBSI
FormatA4
DeliveryNo
Pages20
File Size808.8 KB
Price£130.00


WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001
 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Worldwide Standards
We can source any standard from anywhere in the world


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Customers who bought this product also bought