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SRPS EN ISO 14155-2:2011

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

Jan 31, 2011
95.99   Withdrawal of Standard   Sep 30, 2011

General information

95.99     Sep 30, 2011

ISS

Z076

European Norm

11.100.20  

English  

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Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directive 2007/47/EC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 14155-2:2011
95.99 Withdrawal of Standard
Sep 30, 2011

REVISED BY

WITHDRAWN
SRPS EN ISO 14155:2011

Related project

Adopted from EN ISO 14155-2:2009

Adopted from ISO 14155-2:2003 IDENTICAL

National regulations and standards

"Сл. гласник РС" бр. 40/2019 40/2019
PRAVILNIK O KLINIČKOM ISPITIVANjU MEDICINSKOG SREDSTVA

MINISTARSTVO ZDRAVLjA