BS EN ISO 15197:2015
Current
The latest, up-to-date edition.
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Hardcopy , PDF
English
30-06-2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and development
5 Safety and reliability testing
6 Analytical performance evaluation
7 Information supplied by the manufacturer
8 User performance evaluation
Annex A (informative) - Possible interfering substances
Annex B (informative) - Traceability chain
Annex C (informative) - Rationale for the analytical
performance requirements
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 98/79/EC
Bibliography
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