• There are no items in your cart

NS EN ISO 14155-2 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
Superseded date

05-01-2011

Published date

01-12-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Clinical Investigation Plan (CIP)
  4.3 General information
       4.3.1 Identification of the clinical investigation
             plan
       4.3.2 Clinical investigators, principal clinical
             investigator, co-ordinating clinical investigator,
             investigation centres/site(s)
       4.3.3 Sponsor
       4.3.4 Monitoring arrangements
       4.3.5 Data and quality management
       4.3.6 An overall synopsis of the clinical investigation
       4.3.7 Approval and agreement to the clinical
             investigation plan
  4.4 Identification and description of the medical device
       to be investigated
  4.5 Preliminary investigations and justification of the
       study
       4.5.1 Literature review
       4.5.2 Preclinical testing
       4.5.3 Previous clinical experience
       4.5.4 Device risk analysis and risk assessment
  4.6 Objectives of the clinical investigation
  4.7 Design of the clinical investigation
  4.8 Statistical considerations
  4.9 Deviations from the clinical investigation plan
  4.10 Amendments to the clinical investigation plan
  4.11 Adverse events and adverse device effects
  4.12 Early termination or suspension of the investigation
  4.13 Publication policy
  4.14 Case Report Forms
Annex A (informative) Case Report Forms
Bibliography

Gives requirements for the preparation of a Clinical Investigation Plan (CIP) for 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.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Superseded

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.