Diabetes is one of the most prevalent chronic conditions in India, affecting millions of individuals across all age groups. For effective management, blood-glucose monitoring systems play a vital role, especially those designed for self-testing by patients. Given the sensitive nature of these devices and their direct impact on health, their accuracy, reliability, and safety are non-negotiable.
To ensure standardized quality across the industry, the Bureau of Indian Standards (BIS) mandates compliance with the Indian Standard IS/ISO 15197, which lays down stringent requirements for In Vitro Diagnostic (IVD) Test Systems used in blood-glucose monitoring. Manufacturers must obtain ISI certification for In Vitro Diagnostic Test Systems before marketing their products in India.
Let’s discuss the key elements of the Indian Standard for In vitro Diagnostic Test Systems, the importance of the ISI Mark for In vitro Diagnostic Test Systems, and the certification process as per IS/ISO 15197.
IS/ISO 15197:2013 is the Indian adoption of the international standard ISO 15197. It specifies the performance requirements and evaluation methods for blood-glucose monitoring systems intended for self-testing by individuals with diabetes. The standard covers system accuracy, user performance evaluation, interference testing, information supplied by the manufacturer and labeling and instructions for use. This ensures that the devices not only perform accurately in laboratory settings but also in real-life user environments.
1. Accuracy Requirements: The standard mandates specific accuracy criteria for glucose meters when compared to laboratory methods:
Obtaining the ISI certification for In vitro Diagnostic Test Systems is essential for:
Here’s a step-by-step overview of how to obtain the ISI Mark for In vitro Diagnostic Test Systems under IS/ISO 15197:
To apply for ISI Certification for In vitro Diagnostic Test Systems, manufacturers must provide the following documents:
Additional documentation may be required based on product specifications and environmental regulations.
With diabetes on the rise, the role of accurate and certified blood-glucose monitoring systems is more critical than ever. By complying with IS/ISO 15197 and obtaining the ISI certification for In Vitro Diagnostic Test Systems, manufacturers can ensure that their products meet both clinical standards and regulatory expectations.
The presence of the ISI mark for In vitro Diagnostic Test Systems gives both healthcare professionals and patients confidence that they are using a device that is reliable, precise, and tested under stringent norms. Looking to get your blood-glucose monitoring system BIS certified? EVTL India experts can guide you through documentation, lab testing, factory audits, and complete compliance under IS/ISO 15197.