Standard Svensk standard · SS-ISO 17593:2022

In vitro diagnostik - Krav avseende självtestning vid peroral trombosförebyggande behandling (ISO 17593:2022, IDT)

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Standard Svensk standard · SS-ISO 17593:2022

In vitro diagnostik - Krav avseende självtestning vid peroral trombosförebyggande behandling (ISO 17593:2022, IDT)
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Omfattning
This document specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist oral anticoagulation therapy, including performance, quality assurance and user training and procedures for the validation of performance by the intended users under actual and simulated conditions of use.


This document applies solely to prothrombin time measuring systems used by lay persons for monitoring their own vitamin-K antagonist oral anticoagulation therapy, and which report results as international normalized ratios (INR).


This document is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.


This document is not applicable to:


—    in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist oral anticoagulation therapy used by physicians or healthcare providers;


—    non-vitamin-K antagonist oral anticoagulation therapy (e.g. dabigatran);


—    a comprehensive evaluation of all possible factors that can affect the performance of these systems;


—    the medical aspects of oral-anticoagulation therapy.

Ämnesområden

(11.100.10) Biologisk värdering av medicintekniska produkter (11.100.20) Allmänt Laboratoriemedicin (11.100.01)


Köp denna standard

Standard Svensk standard · SS-ISO 17593:2022

In vitro diagnostik - Krav avseende självtestning vid peroral trombosförebyggande behandling (ISO 17593:2022, IDT)
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Pris: 1 487 SEK
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Produktinformation

Språk: Engelska

Framtagen av: Medicinsk diagnostik, SIS/TK 331

Internationell titel: Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy (ISO 17593:2022, IDT)

Artikelnummer: STD-80035501

Utgåva: 2

Fastställd: 2022-05-19

Antal sidor: 64

Ersätter: SS-ISO 17593:2007