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In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitusWhat is this standard about? BS EN ISO 15197: 2015 specifies requirements for in vitro glucose monitoring systems that measure capillary blood samples to help control diabetes. It also specifies guidelines for design verification procedures and for the validation of performance by intended users. Who is this standard for? Manufacturers of in vitro glucose monitoring systems Users of in vitro glucose monitoring systems Regulatory and conformity

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