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MS ISO 17593:2010 (CONFIRMED:2015)
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)
This Malaysian 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.
Withdrawn
• (none) / (none) / (none)
PDF
17/01/2021
65
NSC 18 - Medical Devices and Facilities for Healthcare
11.100.20
90.00