ISO 15197 In vitro diagnostic test systems

The ISO standard ISO 15197 for In vitro diagnostic test systems is an international standard intended for blood-glucose monitoring systems. The objectives of ISO 15197 are to establish requirements that result in acceptable performance and to specify procedures for demonstrating conformance for these systems when used by laypersons.

ISO 15197

ISO 15197 sets minimum performance criteria for blood-glucose monitoring systems and requirements for system accuracy. A number of physical tests are dictated in section 5, to prove the safety and reliability of such devices. Impact Solutions have experience in undertaking these tests and are able to advise on the correct test levels (which are found from a range of other standards including IEC 61010-1 and IEC 60068-2-64.

Tests in section 5 which Impact perform include Resistance to Heat (in line with IEC 61010-1), which require to drop and static load tests, as well as Vibration testing, drop testing, high & low-temperature testing and humidity exposure.

We can also advise on other tests not included within the standards which you may wish to undertake to prove the reliability and quality of your devices.

Impact pride ourselves on customer service and we will happily discuss your testing needs with a no obligation consultancy prior to any testing to ensure you get the best value out of any testing regime you undertake. If you have an in vitro medical device which needs testing, or you are interested in any of the tests we can offer, please don’t hesitate to get in touch via any of our contact forms!