Aligarh Muslim University Infusion Sets Tender IS/ISO 8536-4 2026 Aligarh Rajasthan

Tender Overview

Organization: Aligarh Muslim University (AMU) Department of Higher Education. The procurement concerns Gravity Feed Infusion Sets (Single Use) conforming to IS/ISO 8536-4 (Q2). Scope includes the supply of infusion sets with integral air-inlet with air filter, vented set air-inlet closure, inclusion of an Intravenous Needle and specified drop factors. Packaging requires a defined number of pieces per pack and explicit shelf-life details. Compliance with Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017, with a valid Medical Device license, is mandatory. The tender emphasizes sample submission (5 numbers) to the Medical Superintendent AMU, and technical evaluation will consider both documentation and sample conformity. The option clause allows quantity variation up to 25%, with adjusted delivery timelines based on last delivery date. This procurement targets AMU in Aligarh, Rajasthan governance context, for standard medical infusion equipment and associated regulatory compliance.

Technical Specifications & Requirements

• Type: Gravity Feed Infusion Set; single-use
• Air handling: Integral air-inlet with air filter; provision for closure of air inlet for vented sets
• Accessories: Intravenous needle provided; injection site included; specified needle length
• Drop factor: Distilled Water measurement in drops/mL; needs explicit calibration
• Packaging: Defined number of pieces per pack
• Shelf life: Residual shelf life requirement to be specified
• Certifications: Compliance with Drugs and Cosmetic Act 1940; MDR 2017 amendments; valid Medical Device license
• Standards: IS/ISO 8536-4 conformity required
• Delivery: Strict adherence to sample-approved specifications; no deviation from approved sample
• Experience/Documentation: Documentation plus sample-based technical evaluation; GST considerations apply

Terms, Conditions & Eligibility

• EMD/SECURITY: Not explicitly stated; bidders should refer to standard AMU terms for bid security
• Samples: Submit 5 piece samples to AMU Medical Superintendent by bid deadline; non-submission leads to rejection
• Compliance: Bids deemed non-compliant if required certificates/docs are missing; non-conforming offers rejected
• Scope: Bid price to include all costs; only supply of goods, no service component
• GST: GST applicability to be self-assessed by bidders; reimbursement as per actuals or applicable rates
• Delivery: Deliver per approved sample; deviations not permitted; quantity variations allowed up to 25%
• Documentation: Include Medical Device license details and MDR 2017 compliance certificates if available
• Evaluation: Technical evaluation based on documentation plus sample conformity; strict adherence to provided sample is mandatory