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BIS Certification for In Vitro Diagnostic Test Systems for Blood-Glucose Monitoring: IS/ISO 15197

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.

What is 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.

Scope of the Indian Standard for In Vitro Diagnostic Test Systems

1. Accuracy Requirements: The standard mandates specific accuracy criteria for glucose meters when compared to laboratory methods:

● At least 95% of results must fall within ±15 mg/dL of the laboratory value at concentrations <100 mg/dL

● At least 95% of results must fall within ±15% at concentrations ≥100 mg/dL

2. User Performance Evaluation: Manufacturers must demonstrate that typical users (non-professionals) can obtain accurate results using the device by following the instructions.

3. Interference Testing: Devices must be tested for interference from common substances like medications, oxygen levels, or hematocrit variation that could affect glucose readings.

4. System Components: The standard applies to the entire system, including the meter, test strips, and control solutions, not just individual parts.

5. Labeling and Instructions: Clear, accurate instructions and labels are required to help users understand device operation, limitations, and interpretation of results.

Why ISI Certification for In vitro Diagnostic Test Systems is Crucial

Obtaining the ISI certification for In vitro Diagnostic Test Systems is essential for:

● Ensuring that blood-glucose monitors are clinically reliable and safe for self-use

● Meeting the regulatory requirements for sale and distribution in India

● Building consumer trust through the presence of the ISI Mark

● Qualifying for government tenders and public health programs

● Supporting better diabetes management outcomes

BIS Certification Process for IS/ISO 15197

Here’s a step-by-step overview of how to obtain the ISI Mark for In vitro Diagnostic Test Systems under IS/ISO 15197:

Application Submission: Submit the completed application form with necessary documentation to BIS.

Document Review: BIS evaluates the submitted documents to verify accuracy and completeness.

Factory Inspection: BIS officials conduct on-site inspections to assess manufacturing processes and quality control systems.

Sample Testing: Product samples are collected and tested at BIS-approved laboratories to verify compliance with Indian standards.

Certification Grant: Upon successful inspection and testing, the BIS issues the certification, allowing the use of the ISI Mark.

Documents Required for BIS Certification

To apply for ISI Certification for In vitro Diagnostic Test Systems, manufacturers must provide the following documents:

● Completed application form

● Detailed manufacturing process information

● Quality control plans and test reports

● Factory layout and equipment details

● Product specifications and technical details

● Business registration proof

● Declaration of conformity to Indian standards

Additional documentation may be required based on product specifications and environmental regulations.

BIS ISI Mark Certification Costing And Timeline

To Know The Process in Detail, Please Visit:

BIS ISI Mark Certification for Domestic Manufactures
BIS ISI Mark Certification for Foreign Manufactures

Under BIS Registration Products ISI and CRS

BIS CRS Registration For IT Products List
BIS ISI Mark Certification For ISI Products List

Conclusion

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.