Standard

NS-EN ISO 14155-2:2003

Jul 2003 Withdrawn

Note: This standard has a new edition: NS-EN ISO 14155-2:2009

Corrigendums and amendments are bought separately.

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Abstract

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.

Document information

Standard from SN
Published: 10 July 2003
Withdrawn: 1 October 2009
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 11.040.01
ICS 11.040.20
National Committee SN/K 113

Legal references

EU law: 90/385/EEC, 93/42/EEC

Product Relations

Replaced by: NS-EN ISO 14155-2:2009

Product life cycle

Current product

Withdrawn

NS-EN ISO 14155-2:2003
Replaced by

Withdrawn

NS-EN ISO 14155-2:2009

NS-EN ISO 14155-2:2003

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NS-EN ISO 14155-2:2009