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.