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

SS-EN-ISO-14155 - 2011 EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

To find similar documents by classification:

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)


Active implantable medical devices. Medical devices

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

ORDER

Price:

$191.87        




Designation Name

SS-EN ISO 14155:2011

Revision Level

2011 EDITION

Status

Current

Publication Date

Nov. 3, 2011

Language(s)

English

Page Count

80

International Equivalent

EN ISO 14155:2011(IDT); ISO 14155:2011(IDT)