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ISO 14155-2:2003

Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
16. 5. 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


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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 14155:1996

TRENUTNO

POVUČEN
ISO 14155-2:2003
95.99 Povučen
21. 1. 2011.

REVIDIRAN OD

NAPUŠTEN
ISO/WD 14155-2

POVUČEN
ISO 14155:2011

Nacionalna preuzimanja

SRPS EN ISO 14155-2:2011  
ISS

Klinička istraživanja medicinskih sredstava na ljudima — Deo 2: Planovi kliničkih istraživanja

95.99   Povučen

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