Standard Swedish standard · SS-ISO 17593:2007

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy (ISO 17593:2007, IDT)

Status: Valid

Scope
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

Subjects

In vitro diagnostic test systems (11.100.10) Biological evaluation of medical devices (11.100.20)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-60938

Edition: 1

Approved: 5/3/2007

No of pages: 59