I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
Hardcopy , PDF
09-02-2011
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (informative) Case Report Forms
Bibliography
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
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