Biocompatibility Testing (ISO 10993) India | NABL Accredited

Auriga Research provides NABL-accredited biocompatibility testing per ISO 10993 for medical devices, combination products, and biomaterials. Our biological evaluation programme covers cytotoxicity, sensitisation, irritation, acute systemic toxicity, genotoxicity, implantation, and haemocompatibility — supporting CDSCO, US FDA, and EU MDR/CE regulatory submissions from a single testing programme.

With over 110 biocompatibility-related enquiries processed, we understand the regulatory landscape for Indian and international medical device registrations. Our team assists with biological evaluation planning per ISO 10993-1, extraction condition selection per ISO 10993-12, and test matrix design based on device contact type, duration, and material composition.

Biocompatibility Test Portfolio

Cytotoxicity — MEM elution, direct contact, and agar overlay (ISO 10993-5)
Sensitisation — Guinea pig maximisation test, LLNA (ISO 10993-10)
Irritation — intracutaneous reactivity, dermal irritation (ISO 10993-10)
Acute systemic toxicity — intravenous and intraperitoneal (ISO 10993-11)
Genotoxicity — Ames test, mouse lymphoma, chromosomal aberration (ISO 10993-3)
Implantation — subcutaneous, intramuscular, bone (ISO 10993-6)
Haemocompatibility — haemolysis, thrombogenicity, complement (ISO 10993-4)
Sub-chronic and chronic systemic toxicity (ISO 10993-11)
Chemical characterisation supporting biological evaluation (ISO 10993-18)

Who Needs Biocompatibility Testing

Medical device manufacturers filing CDSCO Class B/C/D registrations
Companies preparing FDA 510(k) or PMA submissions
EU MDR technical documentation requiring biological evaluation reports
Implant manufacturers (orthopaedic, dental, cardiovascular)
Drug-device combination product developers

Turnaround Time

In-vitro tests (cytotoxicity, genotoxicity, haemolysis) take 10-15 business days. Sensitisation and irritation studies take 30-45 days. Implantation studies range from 4 weeks (short-term) to 26 weeks (long-term). A typical biocompatibility programme for a surface-contact device takes 6-8 weeks; implantable devices take 12-26 weeks depending on the test matrix.

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Frequently Asked Questions

What biocompatibility tests are required under ISO 10993?

ISO 10993-1 provides a framework for selecting tests based on device contact type (surface, external communicating, implant) and contact duration (limited, prolonged, permanent). Common tests include cytotoxicity (ISO 10993-5), sensitisation (ISO 10993-10), irritation (ISO 10993-10), acute systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), implantation (ISO 10993-6), and haemocompatibility (ISO 10993-4). The specific test matrix depends on the biological evaluation plan developed per ISO 10993-1.

Is biocompatibility testing required for CDSCO registration of medical devices?

Yes. CDSCO Medical Device Rules, 2017 require biocompatibility data as part of the technical file for Class B, C, and D medical devices. The testing must follow ISO 10993 series standards. For devices seeking both Indian and international markets, a single ISO 10993 biocompatibility programme satisfies CDSCO, FDA 510(k)/PMA, and EU MDR/CE marking requirements. A biological evaluation plan per ISO 10993-1 should be established before initiating testing.

What is the difference between in-vitro and in-vivo biocompatibility testing?

In-vitro tests (cytotoxicity, genotoxicity, haemocompatibility) are conducted on cell cultures or blood samples in the laboratory — they are faster, less expensive, and serve as screening tools. In-vivo tests (sensitisation, irritation, implantation, systemic toxicity) are conducted in animal models and evaluate the whole-organism biological response. ISO 10993-1 recommends maximising in-vitro testing and using in-vivo tests only when in-vitro data is insufficient for risk assessment.