Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy Ingestion-build-279162 and operation and maintenance instructions

and operation and maintenance instructions

ISO 17090 should be approached as a whole

mechanically or by a combination of both

including resumability

risk and accidents

Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy Ingestion-build-279162 and operation and maintenance instructionsBS ISO 17593 is an international standard for manufacturers of in vitro medical devices, and other organizations such as regulatory authorities and conformity assessment bodies who have responsibility for assessing the performance of those systems. BS ISO 17593 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