Standard

NS-EN ISO 14155-2:2009

Oct 2009 Withdrawn

Corrigendums and amendments are bought separately.

Language English

Services Read Online (No printing ) kr 772,00 Printed and bound Delivery time: 5-10 days kr 965,00

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

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.

Document information

Standard from SN
Published: 1 October 2009
Withdrawn: 1 May 2011
Edition: 2009-07
Version: 1
Document type: NAT
ISBN:

ICS 11.100.20
National Committee SN/K 113

Legal references

EU law: 2007/47/EC, 90/385/EEC, 93/42/EEC

Product Relations

Replaced by: NS-EN ISO 14155:2011
Referred by: NS-EN ISO 10451:2010
Referred by: NS-EN ISO 22794:2009
Replaces: NS-EN ISO 14155-2:2003
Adopted from: EN ISO 14155-2:2009 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 14155-2:2003
Current product

Withdrawn

NS-EN ISO 14155-2:2009
Replaced by

Withdrawn

NS-EN ISO 14155:2011

NS-EN ISO 14155-2:2009

Access to standards for the entire organization

Benefits of our business solution:

Contact us today for a non-binding offer