Banaras Hindu University Biological Indicators Tender Varansi Uttar Pradesh 11138 IS/ISO 11138-1 MDR 2017 2026

Tender Overview

Banaras Hindu University (Department of Higher Education) in VARANASI, UTTAR PRADESH seeks supply of Biological Indicators for Moist Heat Sterilization Processes. Tender includes EMD ₹180,000 and requires compliance with IS/ISO 11138-1 (latest revision), MDR 2017, and ISO 13485 certification for manufacturing. Products must have batch-wise test reports per MDR, provide advance samples for buyer approval, and meet minimum shelf life criteria from manufacture. The Bidder must ensure delivery terms aligned with option clauses allowing ±25% quantity adjustments and delivery time calculations. The contract emphasizes batch availability, certifications, and documentation at bid submission. Unique aspects include mandatory certifications, advance sampling, and supplier qualification through buyer surveillance. Targeted bidders are manufacturers or authorized suppliers with MDR-compliant medical device capabilities and ISO 13485 registration. The scope focuses on quality-controlled biological indicators for moist heat sterilization, suitable for university biosafety and laboratory settings.

Technical Specifications & Requirements

• Conformity to Standard: IS/ISO 11138-1 (Latest Revision) compliance for biological indicators
• Test organism & Carrier material: specified in general product information; must satisfy general requirements
• Certifications: MDR 2017 compliance; ISO 13485 (latest) for manufacturing; batch test reports per MDR 2017
• Shelf life: minimum shelf life from date of manufacture in months; delivery must meet minimum shelf life
• Advance sample: required prior to supply commencement for buyer approval
• Documentation: submission of all certifications, licenses, test reports at bid or along with supplies
• Delivery terms: option clause allows ±25% quantity adjustment; delivery period aligned to last delivery order date
• Other: additional requirements as specified by buyer

Terms, Conditions & Eligibility

• EMD: ₹180,000
• Financial standing: bidder must not be in liquidation or bankruptcy; undertaking to be uploaded
• Delivery: delivery terms tied to last date of original order with option clause adjustments
• Payment terms: as per buyer terms; ensure MDR and ISO compliance in invoicing
• Demonstration: potential physical demonstration; non-attendance may lead to disqualification
• Documents: GST, PAN, ISO 13485 certificate, MDR compliance, batch test reports, OEM authorizations if applicable