NEN-EN-ISO 15197
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
inactive
| Organization: | NEN |
| Publication Date: | 1 June 2003 |
| Status: | inactive |
| Page Count: | 46 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
| ICS Code (Diagnostic equipment): | 11.040.55 |
scope:
Specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus.
Document History
June 1, 2015
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
NEN-EN-ISO 15197 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the...
June 1, 2013
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
February 1, 2011
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitu
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures...
March 1, 2005
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
A description is not available for this item.
NEN-EN-ISO 15197
June 1, 2003
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by...
March 1, 2000
Determination of performance criteria for in vitro blood glucose monitoring systems for management of human diabetes mellitus
Specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by...