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Standards [CURRENT]

BS EN ISO 15197

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Edition 2015-06-30

Standards [CURRENT]

ISO 17593

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Edition 2022-03

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: in vitro diagnostic reagents for self-testing
Edition 2024-06-12

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: in vitro diagnostic instruments for self-testing
Edition 2024-06-12

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: in vitro diagnostic instruments for self-testing
Edition 2012-05-01

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: in vitro diagnostic reagents for self-testing
Edition 2012-05-01

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Edition 2015-12-18

Standards [CURRENT]

SN EN ISO 15197

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
Edition 2015-11

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