Health and Family Welfare Services Department Puducherry Arterial Blood Gas Analyzer Tender 2025 MDR 2017 ISO 13485

Tender Overview

The Health And Family Welfare Services Department Puducherry is procuring an Arterial Blood Gas Analyzer (ABG) for clinical use, with scope covering Supply, Installation, Testing and Commissioning (SITC) and operator training, alongside any statutory clearances. Equipment type is a Hand Held, cartridge-based ABG analyzer capable of measuring pCO2, pO2, Na+, K+, pH plus calculated parameters like HCO3-, base excess, and TCO2. It supports data transfer to LIS/HIS, includes a patient bar code facility, external thermal printer, and a 30-minute battery backup. The model must comply with MDR 2017 and ISO 13485, with IEC/EN 60601-1 safety standards. This procurement emphasizes calibration, onboard data handling, and room-temperature reagent storage (2–30°C).

Technical Specifications & Requirements

• Product: Arterial Blood Gas Analyzer (hand held, cartridge-based)
• Measured parameters: pCO2, pO2, Na+, K+, pH; calculated HCO3-, Base Excess, TCO2; additional parameters: Cl-, iCa, Glu, BUN, Hct, Creatinine, Lactate
• Certifications: MDR 2017, valid drug license, ISO:13485 (latest), IEC/EN 60601-1 safety; BIS license and type test certificates required
• Interfacing: LIS/HIS data transfer capability; patient bar code facility; external thermal printer; auto-calibration capability
• Power & storage: AC mains + rechargeable battery; 30-minute battery backup; reagents stored 2–30°C
• Delivery scope: SITC including operator training and any statutory clearances (if applicable) as part of the bid
• Quality & tests: Product test reports per MDR 2017; vendor to provide all certificates and licenses with bid
• Warranty: Not specified in data; bidders should expect manufacturer warranty terms as per standard ABG devices

Terms, Conditions & Eligibility

• Scope of supply: SITC plus operator training and statutory clearances if required
• Certificates required: BIS licence, type test, MDR compliance, drug license, ISO 13485; product-specific approvals
• Documentation: Upload all prescribed certificates with bid submission
• Standards: MDR 2017, ISO 13485, IEC/EN 60601-1; BIS certification
• Submission focus: Technical compliance, manufacturing quality, and regulatory registrations; no BOQ items
• Eligibility: Bidder must hold necessary certifications and valid drug license for the product; complete installation and commissioning capability
• Delivery/Installation: Timelines to be confirmed; ensure SITC milestones align with hospital requirements
• Payment & penalties: Not detailed in data; bidders should anticipate standard government payment terms and performance guarantees