Standard

SN EN ISO 14155-2:2010

Jan 2010 Withdrawn

Existing or new amendments and versions must be purchased separately.

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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.

Products specifications

Standard from INB
Published: January 1 2010
Withdrawn: May 1 2011
Effective: January 1 2010
Document type: EN
Pages
ISBN:

ICS: 11.100.20
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 129

Product Relations

Replaced by: SN EN ISO 14155:2011
Adopted from: ISO 14155-2:2003, IDT
Replaces: SN EN ISO 14155-2:2003

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (0)

Version history History (2)