The new ISO 15197:2013, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, differs from the previous 2003 version on the following points:
- Increased accuracy for glucose meter systems, in particular for glucose values greater than 75 mg/dl (4,2 mmol/l)
- Manufacturers of glucose meter systems must ensure their technology enables accuracy to improve from +-20% to +-15%
- The new version accounts for 99% of results, as opposed to 95% for the previous one
- For the first time, the standard provides formal acceptance criteria for accuracy as regards testing by patients and assessment of interferents (including hematocrit).
Project leader for ISO 15197, Dr. Alan Cariski, comments, "More accurate glucose measurements will help patients to better regulate their diabetes through more informed treatment decisions that may affect, for example, dietary intake and medication dose, especially insulin."