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Glavni meni

ISO 14155-1:2003

Clinical investigation of medical devices for human subjects — Part 1: General requirements
26. 2. 2003.
95.99   Povučen   21. 1. 2011.

Опште информације

95.99     21. 1. 2011.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:
protect human subjects;ensure the scientific conduct of the clinical investigation;assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
ISO 14155-1:2002
specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

Životni ciklus

PRETHODNO

POVUČEN
ISO 14155:1996

TRENUTNO

POVUČEN
ISO 14155-1:2003
95.99 Povučen
21. 1. 2011.

REVIDIRAN OD

NAPUŠTEN
ISO/PWI 14155-1

POVUČEN
ISO 14155:2011

Nacionalna preuzimanja

Klinička istraživanja medicinskih sredstava na ljudima — Deo 1: Opšti zahtevi

95.99   Povučen