Read blood glucose meter reviews:
Choose a blood glucose meter… Abbott Freestyle Freedom Lite Abbott Freestyle Libre Abbott Freestyle Lite Abbott Freestyle InsuLinx Abbott Optium Neo Abbott Optium Xceed Accu-Chek Advantage Accu-Chek Aviva Accu-Chek Aviva Active Accu-Chek Aviva Combo Accu-Chek Aviva Expert Accu-Chek Mobile Accu-Chek Aviva Nano Ascensia Contour XT Ascensia Contour Link Ascensia Contour NEXT Ascensia Contour NEXT USB Ascensia Contour USB Bbraun Omnitest 3 GlucoMen GlucoMen GM GlucoMen LX Plus GlucoMen Visio GlucoRx Blood Glucose Meter GlucoRx Nexus Blood Glucose Meter GlucoRx Nexus Mini Blood Glucose Meter Home Diagnostics TRUEone Home Diagnostics TRUEresult Home Diagnostics TRUEresult Twist IME-DC Blood Glucose Meter LifeScan OneTouch Ultra2 LifeScan OneTouch UltraEasy LifeScan OneTouch UltraSmart LifeScan OneTouch Verio LifeScan OneTouch VerioPro LifeScan OneTouch Verio IQ Mendor Discreet Sanofi Aventis BGStar Sanofi Aventis iBGStar SD Codefree Simple Diagnostics Clever Chek CareSens N Blood Glucose Meter Wavesense Jazz Ypsomed mylife Pura

The ISO guidelines for blood glucose meters are a detailed set of standards which blood glucose meters should meet.

The name ISO stands for International Organization for Standardizatio, the organisatio, based in Geneva, Switzerland, that is responsible for defining the standards.

Currently, the set of standards which need to be met are the set of standards that were published in 2003 (ISO: 15197:2003). In 2013, an updated set of standards (ISO: 15197:2013) were published and these newer standards will need to be met blood glucose meter manufacturers by the end of May 2016.

What do the ISO standards require?

The ISO standards have a number of different components which need to be met. The 2003 ISO standards included system accuracy and user performance components.

The new 2013 ISO standards included additional components such as:

  • Evaluation of instructions of use
  • Influence quantities of interfering substances

The system accuracy requirements are carried out by comparing blood glucose results of meters against the glucose level provided by a laboratory measurement. The YSI 2300 STAT Plus glucose analyser is able to perform the laboratory measurement.

The user performance evaluates the accuracy when the testing is performed by patients.

The evaluation of instructions for use is designed to evaluate whether the instructions for the meter are clear enough.

The influence quantities of interferents tests whether the meter can perform effectively for testing blood that has different levels of substances that could interfere with the result of the test. 24 potential interferents are listed by the ISO 2013 standards and these substances include haematocrit levels (the volume of red blood cells in the blood), cholesterol levels and levels of common drugs such as ibuprofen.

ISO system accuracy standards for blood glucose meters

Currently blood glucose meters need to meet the system accuracy standards of 2003 (ISO: 15197:2003) which state that 95% of blood glucose results should be:

  • Within ± 0.83 mmol/L of laboratory results at concentrations of under 4.2 mmol/L
    (Within ± 15 mg/dl of laboratory results at concentrations of under 75 mg/dL)
  • Within ± 20% of laboratory results at concentrations of 4.2 mmol/L (75 mg/dL) or more

In 2013 new, tighter accuracy standards (ISO: 15197:2013) were drawn up, requiring that 95% of blood glucose results should reach the following standard

  • Within ± 0.83 mmol/L of laboratory results at concentrations of under 5.6 mmol/L
    (Within ± 15 mg/dl of laboratory results at concentrations of under 100 mg/dL)
  • Within ± 20% of laboratory results at concentrations of 5.6 mmol/L (100 mg/dL) or more

The 2013 guidelines also now stipulate that 99% of readings must fall within zones A and B of the Consensus Error Grid for type 1 diabetes.

Blood glucose monitor manufacturers must ensure their blood glucose meters meet the 2013 accuracy standards by the end of May 2016

What do the ISO standards mean for people with diabetes?

The ISO standards are important for ensuring the blood glucose monitors we use are sufficiently reliable on a day to day basis. The move to the tighter 2013 standards is a positive advance as it will mean blood glucose meters will need to be more accurate and therefore provide greater confidence to us as users of the meters.


Which meters meet the ISO standard? contacted all of the UK’s blood glucose meter manufacturers in order to establish which meters meet the latest ISO standards.

Test stripMeterISO 15197:2003ISO 15197:2013
Advocate Redi-Code+  
CareSens N  
Contour NEXT  
Contour TS  
CozyLab S7  
Dario Lite  
Finetest Lite  
FreeStyle Lite  
FreeStyle Optium 
GlucoDock Glucose 
GlucoMen areo Sensor  
GlucoMen GM 
GlucoMen LX Sensor  
GlucoMen Sensor  
GlucoMen Visio  
GlucoRx HCT Glucose Test Strips  
GlucoRx Original Strips  
GlucoRx Nexus Strips  
MediTouch 2  
Mylife Pura  
Mylife Unio  
Chemical Reagent  
Omnitest 3
On-Call Advanced  
OneTouch Select Plus 
OneTouch Ultra  
OneTouch Verio  
OneTouch Vita  
palmdoc iCare Advanced (formerly iCare Advanced)   
palmdoc iCare Advanced Solo (formerly iCare Advanced Solo)  
SD Codefree  
SuperCheck Plus  
SuperCheck 2  
 TRUEresult twistCompliantCompliant
TrueTrack SystemTRUEtrackCompliant
 TRUEyou miniCompliantCompliant
WaveSense JAZZ  
WaveSense JAZZ Duo  


GMMMG evaluation of blood glucose test strips

In 2015, the NHS Greater Manchester Medicines Management Group (GMMMG) published a review of blood glucose meters which included the accuracy of blood glucose test strips. [142] To help with interpreting results, the following lists state which meters fall into the accuracy groups defined by the GMMMG.

The grouping is intended as a recommendation for the 12 clinical commissioning groups (CCGs) in the Greater Manchester area and does not inherently denote a lack of quality in the meters or test strips. Please note that this is not a comprehensive listing of ISO compliant blood glucose meters and as more information becomes available, this page will be updated.

Group 1

The following meters were listed in the review as providing independent and published evidence of attainment of the 2013 ISO accuracy standards (defined as Group 1):

Group 2

The review also listed the following meters for which manufacturers provided independently assessed but non-published evidence of conformity to ISO 15197:2013 accuracy standards (defined as Group 2):

Considered for the GMMMG ‘Do Not Prescribe’ List

The review also listed the following meters to be considered for the Greater Manchester ‘Do Not Prescribe’ list. Blood glucose test strips featured on this list are given reasons for exclusion. Reasons include the blood glucose test strips no longer being promoted by the manufacturer, being excluded from the review due to a lack of response from the manufacturer, or have insufficient evidence of meeting ISO 15197:2013 accuracy standards at time of evaluation (December, 2015).

Excluded due to no response

No longer promoted by manufacturer

Insufficient evidence of meeting ISO15197:2015 accuracy standards as per evaluation

† SMBG meter has recently been updated and confirmed by Bayer that the device meets international standards. No further information had been provided within the evaluation period.

^ In October 2015 Neon diagnostics have confirmed with the GMSS medicines optimisation team that independent and published evidence will be available confirming the system meets updated international standards. No further information had been provided within the evaluation period.

*Test strips not promoted within Greater Manchester area.

Note that the ‘do not prescribe’ recommendation is only intended to be valid for CCGs in the Greater Manchester area.


Please enable JavaScript to view the <a href=””>comments powered by Disqus.</a>

Get our free newsletters

Stay up to date with the latest news, research and breakthroughs.

You May Also Like

Wavesense – Keynote, Keynote Pro

Choose a blood glucose meter… Abbott Freestyle Freedom Lite Abbott Freestyle Libre…

Blood Glucose Testing for Type 2 Diabetes

In the UK, the National Health Service (NHS) does not permit people…