Standard

SN EN ISO 15197:2015

Current

Existing or new amendments and versions must be purchased separately.

Language
Services

Abstract

ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus. ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.

Products specifications

  • Standard from INB
  • Published:
  • Effective:
  • Document type: EN
  • Pages
  • ICS: 11.100.10
  • Publisher: SNV
  • Distributor: SNV
  • National Committee: INB/NK 157

Legal references

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law:
Law referenceRestrictions
812.213
Designated under following EU law:
Law referenceRestrictions
98/79/EG

Product Relations