ZP is an ISO13485 contract developer and manufacturer of electrochemcial sensors, biosensors, IVDs and wearables; including glucosing monitoring technologies for diabetics. As part of this we test against ISO15197:2013
ISO 15197:2013 is an international standard that specifies the requirements for the performance and accuracy of self-monitoring blood glucose systems (SMBG) used by people with diabetes to test their blood glucose levels. The standard includes requirements for measurement accuracy, system precision, and user performance, as well as guidelines for labeling and user instructions. It is intended to ensure that SMBG systems are accurate and reliable, and to promote consistency in the performance of these systems across different manufacturers and models.
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