CSA Z316.4-1994(R2002)

Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management

CSA Z316.4-1994(R2002) 发布历史

CSA Z316.4-1994(R2002)由SCC 发布于 1994-03-31。

CSA Z316.4-1994(R2002)在国际标准分类中归属于: 11.040 医疗设备。

CSA Z316.4-1994(R2002) 的最新版本是哪一版？

最新版本是 CSA Z316.4-1994(R2002) 。

CSA Z316.4-1994(R2002)的历代版本如下：

• 0000年 CSA Z316.4-1994(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.

标准号

CSA Z316.4-1994(R2002)

发布

1994年

发布单位

SCC

当前最新

CSA Z316.4-1994(R2002)

 

 

代替标准

2002-03-01

被代替标准

CAN/CSA-ISO 15197:05 (R2010)

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