About 1 million people in the Netherlands have diabetes. And every day another 200 are added. This makes it the most common disease in our country. Diabetes dominates the patient's life because it must be taken into account at every meal. Diabetic patients who inject insulin must also measure their blood sugar level/glucose with a glucose meter one or more times a day. But how do you know whether your glucose meter is showing the correct values?
CE & ISO
All medical devices marketed in Europe must legally bear a CE mark. The CE marking is not a quality mark. This is necessary for various medical devices, including glucose meters. That is why the ISO (International Organization for Standardization) was created. ISO, together with stakeholders in the field, draws up standards that the product must meet. These stakeholders consist of practitioners, patients and of course the manufacturers.
NEN
In the Netherlands, the organization NEN (Dutch Standard) represents the Dutch position on this subject. The standard for the measuring equipment is laid down in NEN-EN-ISO 15197. 'In-vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing for the purpose of regulating diabetes mellitus. This standard was last adjusted in 2015. It was then determined that the permitted measurement deviation had to be reduced from 20% to 15%. Manufacturers must also take into account the use of glucose meters by lay people.
The standards laid down in NEN-EN-ISO 15197 implement the European Directives for medical devices. If manufacturers follow these and record in their technical file which standards they have used, they meet the requirements of Dutch law.
What does this mean to you?
This is actually very simple. The advice is to purchase a glucose meter that meets the ISO standard. All glucose meters on diabetesmagazijn.nl comply with this. Do you have an old glucose meter? Then there is a good chance that it will disappear, the same goes for the test strips. A switch to a new meter is therefore necessary.
Are you unsure whether your glucose meter meets the latest ISO standard? Then take contact with us. We are happy to help you.