ISO 15197:2013
International Standard
Current Edition
·
Approved on
14 May 2013
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 15197:2013 Files
English
46 Pages
Current Edition
82.5 OMR
ISO 15197:2013 Scope
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.
Best Sellers
GSO 150-2:2013
Gulf Standard
Expiration dates for food products - Part 2 :
Voluntary expiration dates
OS GSO 150-2:2013
GSO 150-2:2013
Omani Standard
Expiration dates for food products - Part 2 :
Voluntary expiration dates
OS GSO 2055-1:2015
GSO 2055-1:2015
Omani Standard
HALAL FOOD - Part 1 : General Requirements
GSO 2055-1:2015
Gulf Technical Regulation
HALAL FOOD - Part 1 : General Requirements
Recently Published
OS 1658:2025:2025
Omani Standard
Disposable Garbage Bags
ISO 7718-2:2025
International Standard
Aircraft — Passenger doors interface requirements for connection of passenger boarding bridge or passenger transfer vehicle — Part 2: Upper deck doors
ISO/IEC/IEEE 32430:2025
International Standard
Software engineering — Software non-functional size measurement
ISO 10218-1:2025
International Standard
Robotics — Safety requirements — Part 1: Industrial robots