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SRPS EN ISO 14155:2019

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

Jan 31, 2019
95.99   Withdrawal of Standard   Jan 29, 2021

General information

95.99     Jan 29, 2021

ISS

Z076

European Norm

11.100.20  

English  

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Scope

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ISO 14155:2011 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.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 14155:2011

NOW

WITHDRAWN
SRPS EN ISO 14155:2019
95.99 Withdrawal of Standard
Jan 29, 2021

REVISED BY

PUBLISHED
SRPS EN ISO 14155:2021

Related project

Adopted from EN ISO 14155:2011

Adopted from ISO 14155:2011 IDENTICAL

National regulations and standards

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

MINISTARSTVO ZDRAVLjA