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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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.

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

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