Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Blood Bag Testing Laboratory — IS 12065 & ISO 3826

Blood bags are a mandatory BIS-certified product in India under IS 12065 and a Class C medical device under CDSCO MDR 2017 — material quality directly impacts patient safety, so the regulator requires complete type-test evidence before licensing. Auriga Research is a NABL-accredited blood bag testing laboratory providing comprehensive quality evaluation of PVC and non-PVC blood collection bags per IS 12065, ISO 3826, and Indian Pharmacopoeia standards.

Our scope covers extractables (reducing substances, heavy metals, UV absorbance), DEHP / alternative plasticiser migration, haemolysis, seal and peel strength, transparency, WVTR, anticoagulant potency (CPD / CPDA-1), sterility, and biocompatibility per ISO 10993. Reports support BIS ISI certification applications under the Conformity Assessment Scheme and CDSCO Form MD-9 / MD-15 manufacturing and import licence dossiers.

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 BIS for ISI mark certification and by CDSCO licensing authorities for manufacturing and import approvals. BIS certification under IS 12065 is mandatory for blood bags sold in India — Auriga's NABL-accredited reports are accepted by BIS for this certification.

Complete type-test programme in 20–25 working days | Express available

Get a Quote Call +91-7428116100

Blood Bag Testing Parameters

Each parameter is mapped to its IS 12065 / IP / ISO method so QA and regulatory teams can match scope to the BIS ISI or CDSCO submission at a glance.

IP Extractables

Extractables

Reducing substances, heavy metals, and UV absorbance per Indian Pharmacopoeia extractable limits.

GC-MS

Plasticiser Migration

DEHP and alternative plasticiser (TOTM / BTHC / DINCH) migration into simulated blood and saline by GC-MS.

Headspace GC

Vinyl Chloride Monomer

Residual vinyl chloride monomer (VCM) in PVC bags by headspace GC.

Haemolysis

Blood Compatibility

Haemolysis rate and blood compatibility studies for direct blood-contact safety.

IS 12065

Seal & Peel Strength

Seal strength and peel strength per IS 12065 — bag integrity through handling and centrifugation.

WVTR

Water Vapour Transmission

Water vapour transmission rate to confirm anticoagulant concentration is maintained over shelf life.

Physical

Transparency & Flexibility

Transparency, flexibility, and visual inspection per IS 12065 physical requirements.

HPLC

Anticoagulant Potency

CPD / CPDA-1 anticoagulant solution potency by HPLC.

IP Sterility

Sterility

Sterility testing per Indian Pharmacopoeia sample plan.

USP <788>

Particulate Contamination

Sub-visible and visible particulate contamination in the fluid pathway.

ISO 10993

Biocompatibility

Cytotoxicity, sensitisation, and haemocompatibility per the ISO 10993 series.

How It Works

Get a Quote

Share your bag configuration (single, double, triple, quadruple), plasticiser system (DEHP or non-DEHP), regulatory target (BIS ISI under IS 12065, CDSCO MD-9 / MD-15, or export), and the testing scope you need. Your dedicated SPOC confirms the test protocol, sample quantity, and turnaround time before you dispatch anything.

Send Your Sample

Dispatch sterile-handled finished blood bag units of a single manufacturing lot 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

Your bags are tested per the validated IS 12065 / IP / ISO 3826 methods by Auriga's medical device and microbiology teams. Every result — extractables, haemolysis, seal strength, sterility, biocompatibility — passes through a formal internal QA review and sign-off before the report is generated.

Receive Your NABL Report

Your NABL-accredited blood bag test report is delivered digitally within the committed turnaround time. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017, are accepted by BIS for ISI certification under IS 12065 and by CDSCO for manufacturing / import licensing under MDR 2017, and are formatted for direct attachment to the regulatory dossier. You can track sample status in real time through YLIMS.

Turnaround Time

Service	Standard TAT	Express
Physical tests (seal strength, transparency, dimensions, WVTR)	5–7 business days	Available
Chemical extractables (reducing substances, heavy metals, UV absorbance)	10–12 business days	Available
DEHP / plasticiser migration by GC-MS	10–12 business days	On request
Haemolysis and blood compatibility studies	15–20 business days	On request
Sterility testing per Indian Pharmacopoeia	14 business days	Fixed by IP
Anticoagulant potency (CPD / CPDA-1) by HPLC	7–10 business days	Available
Biocompatibility (ISO 10993 core battery)	20–25 business days	On request
Full type-test programme for BIS ISI / CDSCO	20–25 business days	48–72 hour gap-fill available

Who Needs Blood Bag Testing

Blood bag and transfusion set manufacturers applying for or renewing BIS ISI certification under IS 12065.
Blood bag manufacturers filing CDSCO Form MD-9 manufacturing licence applications under MDR 2017.
Importers registering blood bags for the Indian market under CDSCO Form MD-15.
IV set, blood collection tube, and disposable transfusion device manufacturers needing equivalent extractables, haemolysis, and biocompatibility data.
Companies developing non-DEHP alternative plasticiser blood bags (TOTM, BTHC, DINCH) requiring full toxicological characterisation.
Blood banks and hospital procurement teams verifying supplier quality before tender award.
Contract manufacturers running periodic revalidation and routine surveillance testing for BIS licence retention.
Quality teams handling post-market complaints — haemolysis incidents, seal failures, or sterility excursions — needing root-cause testing.
Regulatory consultants assembling Device Master Files and BIS licence applications on behalf of manufacturer clients.
Export-oriented blood bag manufacturers needing ISO 3826 conformity reports for international tender or regulatory submissions.

Why Auriga for Blood Bag Testing

NABL scope explicitly covering IS 12065 and ISO 3826

Blood bag testing is explicitly listed on our NABL scope certificate under IS 12065 and ISO 3826 — not a derivative — which means BIS recognises the report for ISI certification and CDSCO accepts it without follow-up scope verification.

BIS-accepted reports for IS 12065 ISI certification

Reports are accepted by BIS for the mandatory ISI mark certification scheme under IS 12065 — the regulatory gating credential for selling blood bags in India.

CDSCO-recognised laboratory under MDR 2017

Reports are routinely accepted in CDSCO Form MD-9 manufacturing licence and MD-15 import licence applications for Class C blood-contact devices — Auriga is a CDSCO-recognised laboratory.

Full DEHP and non-DEHP plasticiser capability

GC-MS validated methods for DEHP and all approved alternative plasticisers (TOTM, BTHC, DINCH) — supporting both legacy PVC bags and the next-generation phthalate-free product lines.

Haemolysis, biocompatibility, and sterility under one roof

Biological evaluation (ISO 10993 series), haemolysis, sterility, and chemical / physical testing all performed in-house — no sample transfer delays when a regulator asks for cross-correlated data.

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 BIS surveillance officers, CDSCO inspectors, and blood-bank procurement committees look for in a testing partner.

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Frequently Asked Questions

What tests are required for blood bag approval in India?

Blood bag testing in India follows IS 12065 and Indian Pharmacopoeia requirements. Key tests include extractables in saline and aqueous solutions (reducing substances, heavy metals, UV absorbance), haemolysis testing, seal strength and peel strength, transparency, flexibility, water vapour transmission rate, anticoagulant potency (CPD/CPDA-1), sterility, particulate contamination, and biocompatibility per ISO 10993. CDSCO requires this complete testing battery for manufacturing licence approval and BIS requires it for ISI certification under IS 12065.

Is BIS certification mandatory for blood bags sold in India?

Yes. Blood bags fall under mandatory BIS certification under IS 12065 — both Indian manufacturers and importers must hold a valid BIS licence to sell blood bags in the Indian market. BIS requires testing by a recognised laboratory (BIS-recognised under its Scheme for Recognition of Laboratories or NABL-accredited with the scope explicitly covering IS 12065). Auriga Research is NABL-accredited under ISO/IEC 17025:2017 with IS 12065 testing in scope, and our reports are accepted for BIS ISI certification applications under the Conformity Assessment Scheme. Operating without BIS certification in this category is a regulatory non-compliance attracting product seizure and licence cancellation.

What material-specific tests apply to PVC blood bags?

PVC blood bags contain DEHP (di-2-ethylhexyl phthalate) as a plasticiser. Testing includes DEHP migration into stored blood (quantified by GC-MS), extractable content in aqueous and saline media, and vinyl chloride monomer residue. The Indian Pharmacopoeia specifies limits for these extractables. Non-DEHP blood bags (using TOTM, BTHC, or DINCH plasticisers) require equivalent extractable and compatibility testing — Auriga supports characterisation of all approved alternative plasticisers along with the supporting toxicological context.

What is the turnaround time for complete blood bag testing?

Physical tests (seal strength, transparency, dimensions) take 5–7 business days. Chemical extractables testing takes 10–12 business days. Haemolysis and blood compatibility studies take 15–20 business days. Sterility testing takes 14 business days per Pharmacopoeia requirements. A complete blood bag testing programme — type-test for BIS ISI application or CDSCO manufacturing licence — takes approximately 20–25 business days. Express turnaround is available for time-critical regulatory submissions.

What sample quantity is required for blood bag type testing under IS 12065?

Type testing per IS 12065 typically requires 40–60 finished blood bag units of each variant (single, double, triple, quadruple) for full evaluation — extractables (10 bags), seal and physical tests (10 bags), haemolysis and biological evaluation (10 bags), sterility (20 bags per IP Sample Plan), and reserve / repeat samples. Confirm exact quantities with your SPOC at the quote stage. For routine surveillance and revalidation testing, batch sample quantities are smaller (typically 10–15 bags). All samples must be from a single manufacturing lot for type-test data to be valid for the BIS licence application.

What is the regulatory consequence of inadequate blood bag testing data on a CDSCO or BIS submission?

Blood bags are a Class C medical device under CDSCO MDR 2017 and a mandatory BIS-certified product. (1) CDSCO: an MD-9 (manufacturing) or MD-15 (import) application without complete IS 12065 / IP testing will be returned with a sterility-assurance or material-safety deficiency — typically blocking the registration timeline by 3–6 months. (2) BIS: an ISI mark application without IS 12065 test reports from a recognised lab is closed at preliminary scrutiny. (3) Post-market: a haemolysis or sterility complaint on a distributed lot triggers CDSCO Materiovigilance reporting and a full recall. Building a robust type-test data package and a periodic routine-surveillance programme is materially cheaper than reacting to a post-market incident.

Can Auriga support contesting a CDSCO or BIS finding on blood bag testing with additional data?

Yes. Gap-fill testing in response to a CDSCO deficiency letter or a BIS pre-licence inspection finding is a routine workflow. The path is: (1) review the regulator's specific finding with your SPOC; (2) identify whether the gap requires fresh type-testing, additional extractables work, biocompatibility re-evaluation, or sterility re-validation; (3) run the targeted top-up programme — not a full re-test; (4) issue an NABL-accredited supplementary blood bag test report formatted as an addendum to the original submission. Express 48–72 hour turnaround is available for time-critical regulatory response windows.

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