Health standards for World Health Day
This week, on the occasion of World Health Day, ISO is launching a social media campaign to raise awareness about the importance of ensuring health standards are in place everywhere in the world.
p
54976
ISO 15197:2013 Preview
In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
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.
General information
-
Status : PublishedPublication date : 2013-05
-
Edition : 2Number of pages : 46
-
- ICS :
-
In vitro diagnostic test systems
Buy this standard
| Format | Language | |
|---|---|---|
| PDF + ePub | ||
| Paper |
- CHF158
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
-
Previously
ISO 15197:2003
-
Now confirmed
ISO 15197:2013
You may be interested in:
on
on
More accurate self-testing results for diabetes patients with new ISO standard
Diabetes patients will benefit from the latest version of an ISOstandard for self-testing glucose monitoring systems. The standard requiresthat manufacturers of these systems provide even greater accuracy.
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information