What is this standard about?
BS EN ISO 15197:2015 specifies requirements for in vitro glucose monitoring systems that measure capillary blood samples to help control diabetes. It also specifies guidelines for design verification procedures and for the validation of performance by intended users.
Who is this standard for?
- Manufacturers of in vitro glucose monitoring systems
- Users of in vitro glucose monitoring systems
- Regulatory and conformity authorities with responsibility for assessing the performance of these systems
Why should you use this standard?
Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus. This is caused by a relative or absolute deficiency in insulin secretion or by insulin resistance leading to abnormal concentrations of glucose in the blood, which may result in acute and chronic health complications. When used properly, a glucose monitoring system allows the user to monitor and take action to control the concentration of glucose present in the blood.
BS EN ISO 15197 is intended for blood-glucose monitoring systems used by lay persons. It outlines requirements for acceptable performance and specifies procedures for demonstrating conformance to this international standard.
What’s changed since the last update?
BS EN ISO 15197 has been systematically reviewed by experts, who have taken into consideration medical developments and changes to clinical best practice. Changes include:
- Revised performance criteria
- New considerations concerning the basis for the minimum analytical performance of blood glucose devices intended for self-monitoring, described in Annex C
- Amendments to safety and reliability testing criteria and user performance evaluation