BAS EN ISO 14155-2:2010
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
General Information
Status: Withdrawn
No. of pages: 14
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
1 Scope
This part of EN ISO 14155 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.
This Standard does not apply to in vitro diagnostic medical devices.
Lifecycle
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Original document and degree of correspondence
- EN ISO 14155-2:2009, identical
- ISO 14155-2:2003, identical