DIN EN ISO 14155

DIN - Deutsches Institut für Normung e. V.

English -- Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011);
German -- Klinische Pruefung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011 + Cor. 1:2011)

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DIN - Deutsches Institut für Normung e. V.

Year: 2012

Abstract: This International Standard 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 this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.
This International Standard 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 clinical investigation 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.
It does not apply to in vitro diagnostic medical devices.
NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of this International Standard will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.

URI: https://yse.yabesh.ir/std/handle/yse/205714

Subject: Bewertung

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DIN - Deutsches Institut für Normung e. V.

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contributor author	DIN - Deutsches Institut für Normung e. V.
date accessioned	2017-09-04T18:23:16Z
date available	2017-09-04T18:23:16Z
date copyright	2012.01.01
date issued	2012
identifier other	IDSFUEAAAAAAAAAA.pdf
identifier uri	https://yse.yabesh.ir/std/handle/yse/205714
description abstract	This International Standard 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 this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. This International Standard 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 clinical investigation 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. It does not apply to in vitro diagnostic medical devices. NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of this International Standard will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.
language	English
title	DIN EN ISO 14155	num
title	English -- Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011)	en
title	German -- Klinische Pruefung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011 + Cor. 1:2011)	other
type	standard
page	68
status	Active
tree	DIN - Deutsches Institut für Normung e. V.:;2012
contenttype	fulltext
subject keywords	Bewertung
subject keywords	Evaluations
subject keywords	Medical devices
subject keywords	Medizinprodukt
subject keywords	Pruefung
subject keywords	Testing