CSA Z316.4-94 (R2000)
Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management
CSA Group , 12/10/1999
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1. Scope
1.1
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.
1.1
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.
Product Information
Published:
12/10/1999
Pages:
13
File Size:
1 file , 1.3 MB
Language:
English
Note:
This product is unavailable in Russia, Ukraine, Belarus
