ISO 15197:2013
In vitro diagnostic test systems.Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Standard No.

ISO 15197:2013

Release Date

2013

Published By

International Organization for Standardization (ISO)

Latest

ISO 15197:2013

Scope

This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.

ISO 15197:2013 Referenced Document

• EN 13612 Performance evaluation of in vitro diagnostic medical devices
• IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*， 2017-01-01 Update
• IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements*， 2020-10-26 Update
• IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment*， 2020-10-28 Update
• IEC 62366 Medical devices - Application of usability engineering to medical devices*， 2014-01-01 Update
• ISO 13485 *， 2018-05-15 Update
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
• ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples*， 2020-04-24 Update
• ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements*， 2022-10-06 Update
• ISO 18113-4 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing*， 2022-10-06 Update
• ISO 18113-5 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing*， 2022-10-06 Update
• ISO 23640 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

ISO 15197:2013 history

• 2013 ISO 15197:2013 In vitro diagnostic test systems.Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
• 2003 ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus