Standard Svensk standard · SS-ISO 17593:2007

In vitro diagnostik - Krav avseende självtestning vid peroral trombosförebyggande behandling (ISO 17593:2007, IDT)

Status: Gällande

Omfattning
This International Standard specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. This International Standard pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which repor

Ämnesområden

(11.100.10) Biologisk värdering av medicintekniska produkter (11.100.20)


Produktinformation

Språk: Engelska

Framtagen av: Laboratoriemedicin, SIS/TK 331

Internationell titel:

Artikelnummer: STD-60938

Utgåva: 1

Fastställd: 2007-05-03

Antal sidor: 59