SSH ISO 17593:2022

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Publication date: Aug 29, 2023

General information

Current stage: 60.60 Effective date: Aug 29, 2023

Originator: DPS

Owner: DPS/KT 140

Type: International Standard

ICS: 11.100.20

Languages: English

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Status: Published

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Scope

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.

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WITHDRAWN
SSH ISO 17593:2007

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PUBLISHED
SSH ISO 17593:2022
60.60 Standard published
Aug 29, 2023

SSH ISO 17593:2022

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

General information

Buying

Scope

Life cycle

PREVIOUSLY

NOW

Related project

Adopted from ISO 17593:2022 IDENTICAL