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Biocompatibility Testing (ISO 10993) India

Biocompatibility is the single most consequential section of a medical device regulatory submission — a weak biological evaluation can block a CDSCO Class C/D registration, an FDA 510(k), or a CE technical file for months. Auriga Research provides NABL-accredited biocompatibility testing per ISO 10993 for medical devices, combination products, and biomaterials, with our NABL accreditation scope explicitly covering the ISO 10993-1 through ISO 10993-18 series.

Our biological evaluation programme covers cytotoxicity (ISO 10993-5), sensitisation and irritation (ISO 10993-10), acute systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), implantation (ISO 10993-6), haemocompatibility (ISO 10993-4), and chemical characterisation (ISO 10993-18) — supporting CDSCO, US FDA 510(k)/PMA, and EU MDR/CE marking from a single testing programme. We assist with biological evaluation plan (BEP) design per ISO 10993-1, extraction condition selection per ISO 10993-12, and test matrix selection based on device contact type, duration, and material composition.

Backed by the Arbro Group's analytical heritage — Arbro Lab since 1990, Auriga Research since 2007 — with NABL ISO/IEC 17025 accreditation, our reports are accepted by CDSCO licensing authorities, FDA 510(k) reviewers, and EU CE Notified Bodies (BSI, TÜV SÜD, DEKRA, DNV).

Initial-screening tests: 10–15 working days | Full programme: 6–26 weeks per BEP

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Biocompatibility Test Portfolio

Each endpoint is mapped to its ISO 10993 part so regulatory and R&D teams can match the test matrix to the biological evaluation plan at a glance.

ISO 10993-5

Cytotoxicity

MEM elution, direct contact, and agar overlay — the baseline screen required for almost every device contact category.

ISO 10993-10

Sensitisation

Guinea pig maximisation test (GPMT) and murine local lymph node assay (LLNA) for delayed-type hypersensitivity.

ISO 10993-10

Irritation

Intracutaneous reactivity and dermal irritation per ISO 10993-10.

ISO 10993-11

Acute Systemic Toxicity

Intravenous and intraperitoneal acute systemic toxicity for devices with blood or internal-tissue contact.

ISO 10993-3

Genotoxicity

Ames test, mouse lymphoma assay, and chromosomal aberration for permanent and long-term contact devices.

ISO 10993-6

Implantation

Subcutaneous, intramuscular, and bone implantation studies for local tissue response evaluation.

ISO 10993-4

Haemocompatibility

Haemolysis, thrombogenicity, and complement activation for blood-contact devices.

ISO 10993-11

Sub-chronic & Chronic Toxicity

Repeat-dose sub-chronic and chronic systemic toxicity for prolonged and permanent-contact devices.

ISO 10993-18

Chemical Characterisation

Extractables / leachables chemical characterisation supporting the biological evaluation plan (BEP).

How It Works

Get a Quote & BEP Design

Share your device type, contact category and duration, material composition, and regulatory target (CDSCO / FDA / CE). Your dedicated SPOC works through the ISO 10993-1 biological evaluation plan (BEP) with you — confirming test matrix, extraction conditions per ISO 10993-12, and exemption justifications before any sample is committed.

Send Your Sample

Dispatch device samples and the agreed BEP with a completed Test Request Form to the nearest Auriga lab. Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Testing begins within 24 hours of sample registration.

Testing and QA Review

Each ISO 10993 endpoint is run per its validated method by Auriga's biological-evaluation team. Every result passes through formal internal QA review and sign-off before the report is generated — including biological response interpretation and comparison against the device's risk profile.

Receive Your NABL Report

Your NABL-accredited biological evaluation report is delivered digitally within the committed turnaround time, formatted for direct inclusion in CDSCO Form MD-9/MD-15 submissions, FDA 510(k) sections, and CE technical files. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017. You can track sample status in real time through YLIMS at any point in the process.

Turnaround Time

Service	Standard TAT	Notes
Cytotoxicity, genotoxicity & haemocompatibility	10–15 business days	Per ISO 10993-5 / -3 / -4
Sensitisation and irritation studies	30–45 days	ISO 10993-10 (GPMT, LLNA, intracutaneous reactivity)
Acute systemic toxicity	4–6 weeks	ISO 10993-11 (IV / IP)
Short-term implantation studies	4–6 weeks	ISO 10993-6 (subcutaneous / intramuscular)
Long-term implantation studies	12–26 weeks	ISO 10993-6 (long-term implant evaluation)
Surface-contact device full programme	6–8 weeks	Cytotoxicity / genotoxicity / haemocompatibility + sensitisation + irritation
Implantable device full programme	12–26 weeks	Driven by long-term implantation study duration
Chemical characterisation (ISO 10993-18)	4–6 weeks	GC-MS + LC-MS + ICP-MS in-house

Who Needs Biocompatibility Testing

Medical device manufacturers filing CDSCO Class B / C / D registrations under the Medical Device Rules 2017 — biocompatibility is mandatory technical-file content.
Companies preparing FDA 510(k) or PMA submissions where the biological evaluation report (BER) is a defined section reviewed against FDA Guidance on Use of ISO 10993-1.
EU MDR technical documentation under Regulation (EU) 2017/745 where Annex I General Safety and Performance Requirements require an ISO 10993-based biological evaluation.
Implant manufacturers — orthopaedic (hip, knee, spinal), dental, cardiovascular (stents, valves, pacemaker leads), ophthalmic (IOLs, contact lenses) — for high-risk device dossiers.
Drug-device combination product developers (drug-eluting stents, pre-filled syringes, transdermal patches, inhalers) where ISO 10993 evaluation supplements the drug-side safety data.
Single-use device manufacturers (catheters, IV sets, surgical instruments, wound dressings) verifying biocompatibility before sterilisation lot release.
CDSCO regulatory consultants assembling device master files and biological evaluation plans (BEP) on behalf of manufacturer clients.
Reformulators or material-change project teams running comparison biocompatibility on a substituted polymer, coating, or supplier change to support an equivalence claim.
Notified Body audit respondents needing additional biological data to close non-conformances raised on existing CE technical files.
OEM component suppliers (resin, coating, adhesive, ink) needing material-level biocompatibility data to support downstream device-manufacturer customers.

Why Choose Auriga for Biocompatibility Testing

NABL ISO/IEC 17025:2017 scope includes ISO 10993-1 through -18

Biocompatibility is explicitly in our NABL scope certificate across the full ISO 10993 series — not derivative, not partial. CDSCO, FDA, and CE Notified Bodies accept the report without follow-up scope verification.

CDSCO-recognised biological evaluation reports

Reports routinely accepted in CDSCO Form MD-9 / MD-15 submissions for Class B / C / D medical devices, FDA 510(k) and PMA biological evaluation sections, and CE technical files reviewed by BSI, TÜV SÜD, DEKRA, and DNV.

Biological Evaluation Plan (BEP) guidance per ISO 10993-1

Our SPOCs run the BEP with you before testing starts — test matrix selection by contact category and duration, extraction condition selection per ISO 10993-12, and justified test waivers where the risk assessment supports them. Saves both time and unnecessary animal studies.

GC-MS, LC-MS, and ICP-MS in-house for chemical characterisation

ISO 10993-18 chemical characterisation supporting the biological evaluation is run on the same lab floor — extractables and leachables identification linked directly to the biological risk assessment. No partner-lab dependency, no data-integrity gaps between chemistry and biology.

BEP-driven test matrix

We design the Biological Evaluation Plan per ISO 10993-1 around your device contact type, duration, and material composition — selecting the test matrix to match the regulator's expectation rather than running every panel by default. Reduces cost and timeline without compromising risk-assessment coverage.

Arbro Group analytical heritage

Established analytical heritage through the Arbro Group (Arbro Lab since 1990, Auriga Research since 2007), with NABL ISO/IEC 17025 accreditation — the audit trail medical device manufacturers, contract sterilisers, and CDSCO regulatory consultants look for in a biocompatibility partner.

Related Services

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 sample quantity is required for an ISO 10993 biocompatibility programme?

Sample quantity depends on the device type, the extraction surface area required by ISO 10993-12, and the test matrix specified in your biological evaluation plan. For a surface-contact device programme (cytotoxicity + sensitisation + irritation), 50 to 100 finished devices or device portions are typical. Implantable device programmes (adding short and long-term implantation studies) require 100 to 200 units. Drug-device combination products may need additional samples for the drug-side and device-side test arms run in parallel. For consistent extraction, samples must be representative of the final sterilised device — extraction is performed on sterilised product where the sterilisation method is established. Confirm the exact quantity with your SPOC during the BEP design step before despatch.

What is the regulatory consequence of inadequate biocompatibility data on a medical device dossier?

Inadequate biocompatibility evidence is the single most common reason for CDSCO, FDA, and CE technical file deficiencies. (1) CDSCO: an MD-9 / MD-15 application with weak biological evaluation will be returned for additional data, blocking the registration timeline by 3-12 months and forcing a top-up testing programme. (2) FDA 510(k): an Additional Information (AI) request citing biocompatibility gaps stops the substantial equivalence clock — common gaps include missing ISO 10993-1 BEP, inadequate extraction conditions, and absent chemical characterisation. (3) CE MDR: a Notified Body non-conformance on biological evaluation can pause CE marking, hold an Article 120 transitional period, or trigger market-removal of devices already on shelf. (4) Post-market: a biocompatibility-driven adverse event reported under CDSCO Materiovigilance or the FDA MAUDE database can trigger a recall and re-testing of all field stock. Building a defensible BEP upfront is materially cheaper than fixing it after submission.

How long is a biocompatibility report valid? When do I need to retest?

A biocompatibility report does not have a statutory expiry — once issued, it remains valid for the specific device, material composition, manufacturing process, and sterilisation method tested. However, retesting (or risk-based supplementary testing) is required when any of the following changes: (a) material composition — polymer grade, coating, adhesive, colour additive; (b) supplier of any material or component contacting the patient or fluid path; (c) manufacturing process — moulding parameters, surface treatment, lubricant; (d) sterilisation method or dose; (e) packaging that contacts the device; (f) any change that could affect leachable / extractable profile. CDSCO and FDA both expect documented evaluation under your BEP whenever a change-control gate is triggered. As a practical default, review the biological evaluation against the current ISO 10993-1 once every 3 years even when no changes have occurred, since the ISO standard itself is periodically revised.

Can Auriga support contesting a CDSCO or Notified Body finding with additional biocompatibility data?

Yes. We routinely run gap-fill or supplementary biocompatibility testing in response to a CDSCO deficiency letter, an FDA AI request, or a Notified Body non-conformance. The workflow is: (1) review the regulator's specific finding with your SPOC; (2) map the gap against the existing BEP and identify the minimum additional endpoint(s) required; (3) run a targeted top-up programme rather than re-doing the full ISO 10993 matrix; (4) format the supplementary biological evaluation report as an addendum referencing the original BER. This is materially faster and cheaper than a full re-run, and is the most common path manufacturers take to close a deficiency without resubmitting from scratch. Reports for gap-fill testing are NABL-accredited and accepted in regulatory response packages.

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