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. 2012 Mar 1;6(2):435–443. doi: 10.1177/193229681200600232

Figure 1.

Figure 1

Illustration of the system accuracy test in accordance with DIN EN ISO 15197, 2003. At least 95% of the glucose measurements (n = 200) must be within the stipulated limit relative to the manufacturer’s reference: ±15 mg/dl (±0.83 mmol/liter) with glucose concentrations <75 mg/dl (<4.2 mmol/liter) and ±20% for glucose concentrations ≥75 mg/dl (≥4.2 mmol/liter). In this example, 96% of the values are within the limits specified in the ISO standard; the specifications in the standard are thus met. Example: plot for system accuracy presentation according to ISO.