Z316.4-94 (R2002)

1.1 Scope This Standard specifies requirements for portable whole blood glucose monitor systems, as defined in Clause 3.3 of this Standard, hereinafter referred to as blood glucose monitor system(s), used to aid in the determination of an individual's blood glucose concentration for the purpose of diabetes management. 1.1.1 Aspects excluded from scope This Standard does not address glucose screening and/or monitoring of neonates for hypoglycemia, and glucose testing for individuals with a blood glucose concentration less than 2.5 mmol/L or greater than 19 mmol/L. 1.2 Object The object of this Standard is the assurance of the performance of the blood glucose monitor system, and to specify tests by which compliance with the requirements can be verified.