UNI EN ISO 14155-2 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
15-03-2011
01-01-2009
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
4.4 Identification and description of the medical device
to be investigated
4.5 Preliminary investigations and justification of the
study
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
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable Medical
Devices
Bibliography
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