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South Eastern Railway IS/ISO 10555-5 Intravascular Catheters Tender Kharagpur 2026

Bid Publish Date

01-Jul-2026, 5:41 pm

Bid End Date

14-Jul-2026, 2:00 pm

Progress

Issue01-Jul-2026, 5:41 pm
AwardPending
Explore all 4 tabs to view complete tender details

Quantity

120

Bid Type

Single Packet Bid

Key Highlights

  • IS/ISO 10555-5 (Part 5) compliant intravascular catheters
  • Wingsed vent fitting with integrated catheter hub injection port
  • Safety feature: protection against accidental needle-stick injuries
  • Color coding per Table 1 IS/ISO 10555-5
  • MDR 2017 compliance and valid Medical Device license
  • OEM warranty certificate mandatory with shipment
  • Original OEM packaging mandatory; no deviations
  • Sample submission to Divisional Railway Hospital, Kharagpur prior to tender closing
  • Quantity variation up to 25% during contract lifecycle

Categories 4

Tender Overview

The procurement is issued by South Eastern Railway under the Indian Railways framework for Over-Needle Peripheral Catheters (Intravascular Catheters) conforming to IS/ISO 10555-5 (Part 5), Q2. The contract covers the supply of goods (catheters) to the Divisional Railway Hospital, Kharagpur, with submission of OEM warranty, original packing, and a mandatory pre-qualification sample. A unique clause allows a ±25% quantity variation at contract placement or during currency. The tender emphasizes OEM warranty and proper packing for medical devices, with a requirement for technical suitability confirmation via sample submission before tender closing. This procurement targets reliable supply to railway medical facilities in Kharagpur, West Bengal and seeks compliance with national medical device regulations. Key differentiators include compliance to MDR 2017, a valid medical device license, and specific catheter construction features such as wings and integrated injection port.

Technical Specifications & Requirements

  • Type of Vent Fitting, With Wings, and Injection Port integral with the catheter hub to ensure secure attachment.
  • Protection against accidental needle stick injuries for safety.
  • Number of Catheter Lumen and Nominal outside diameter (mm) must be specified in the product data sheet.
  • Color coding according to IS/ISO 10555-5 Table 1.
  • Packaging: number of pieces per pack and OEM original packaging requirement.
  • Shelf life / residual shelf life of the product.
  • Certifications: compliance with Drugs and Cosmetic Act 1940 and MDR 2017; valid Medical Device license issued by competent authority.
  • Sample submission to Purnima Mandal, Assistant Nursing Officer, Divisional Railway Hospital, S.E. Railway, Kharagpur (Pin 721301) before tender closure; OEM warranty certificate to be provided with supply.
  • Scope of supply is limited to the goods themselves (no services).

Terms, Conditions & Eligibility

  • Option Clause: Purchaser may increase/decrease order quantity by up to 25% of bid quantity at contract placement or during currency.
  • Delivery timeline: Delivery periods adjusted per option clause, with a minimum extended duration of 30 days.
  • EMD/Financial terms: Not explicitly disclosed in this summary; bidders should prepare standard tender safety deposits per Siemens guidelines and verify at bid stage.
  • Documents: Mandatory OEM warranty, original OEM packing, and submission of technical sample prior to tender closing; compliance with MDR 2017, and valid Medical Device license.
  • Warranty/Support: OEM warranty certificate required with material delivery; deviations not acceptable.
  • Sample submission deadline: Must reach the consignee before tender closing date for technical suitability.
  • Packaging: Stores to be in original OEM packaging with no deviations.
  • Bidders must qualify via sample testing and regulatory compliance as per buyer terms.

Key Specifications

  • Product: Intravascular catheter (Over-Needle Peripheral Catheter)

  • Standards: IS/ISO 10555-5 (Part 5) compliance

  • Vent fitting type: With Wings; injection port integrated with hub

  • Safety: Needle-stick injury protection

  • Lumen count: as per BOQ/product data (not fixed in summary)

  • Nominal outside diameter: specified in product datasheet (mm)

  • Color coding: per Table 1 of IS/ISO 10555-5

  • Packaging: number of pieces per pack; original OEM packing

  • Shelf life: residual shelf life as per vendor data

  • Certifications: Drugs & Cosmetics Act 1940, MDR 2017; valid Medical Device license

Terms & Conditions

  • Quantitative variation up to 25% on ordered quantity at contract initiation and during currency

  • Supply scope limited to goods; no installation or service components

  • Mandatory OEM warranty and original OEM packaging required; sample submission before tender close

Important Clauses

Payment Terms

Not explicitly detailed in the provided data; bidders should verify payment terms during bid stage with issuing authority.

Delivery Schedule

Delivery period linked to option clause; extended time calculated as (additional quantity/original quantity) × original delivery period, minimum 30 days.

Penalties/Liquidated Damages

Not detailed in provided data; check original terms for LD or refund penalties during contract finalization.

Bidder Eligibility

  • Manufacturer or authorized distributor of intravascular catheters

  • Demonstrable MDR 2017 compliance and valid Medical Device license

  • Capability to provide OEM warranty and original packaging

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

No

Item Category

Over-Needle Peripheral Catheters (Intravascular Catheters - Sterile and Single Use) Conforming to IS/ISO 10555 (Part 5) (Q2)

Authority Records

MINISTRY OF RAILWAYS

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Bid Preparation GeM Registration Document Filing

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Documents 5

GeM-Bidding-9525654.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

Other Documents

OTHER

Other Documents

OTHER

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Employees State Insurance Corporation Intravascular Catheter Tender IS/ISO 10555-5 Q2 India 2026

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Closed: 10 February 2026
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Technical Specifications 1 Item

Item #1 Details

View Catalog
Category Specification Requirement
PRODUCT INFORMATION Type of Vent Fitting Removable fitting
PRODUCT INFORMATION With Wings Yes
PRODUCT INFORMATION Injection Port integral with the catheter hub Yes
PRODUCT INFORMATION Protection against accidental needle stick injuries Yes
PRODUCT INFORMATION Number of Catheter Lumen Single Lumen
PRODUCT INFORMATION Nominal outside diameter (mm) 0.9 mm
PRODUCT INFORMATION Color coding (as per Table 1 of IS/ISO 10555-5) Deep Blue
PACKAGING Number of pieces in a Pack 50
SHELF LIFE Residual shelf life of the product Agree to provide residual shelf life of atleast 75% of total shelf life at the time of delivery to the consignee
CERTIFICATIONS Compliance to Drugs and Cosmetic Act 1940 and Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS Availability of valid Medical Device license for the product issued from the competent authority Yes

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Required Documents

1

GST registration certificate

2

Permanent Account Number (PAN) card

3

Experience certificates for similar medical devices

4

Financial statements supporting stability

5

EMD document (as applicable by tender norms)

6

Technical bid documents showing IS/ISO 10555-5 compliance

7

OEM authorization / supplier authorization

8

Medical Device license copy from competent authority

9

Warranty certificate from OEM

Frequently Asked Questions

How to bid for IS/ISO 10555-5 catheter tender in Kharagpur?

Bidders must submit OEM warranty, original OEM packaging, and a pre-tender sample to the Divisional Railway Hospital, Kharagpur. Ensure MDR 2017 compliance and a valid Medical Device license. Prepare documentation including GST, PAN, experience certificates, financials, and OEM authorization. Follow the option clause for quantity variation up to 25% and confirm delivery timelines.

What documents are required for intravascular catheter procurement in West Bengal?

Required documents include GST certificate, PAN card, experience certificates for similar devices, financial statements, EMD documents, technical bid with IS/ISO 10555-5 compliance, OEM authorization, and a valid Medical Device license. OEM warranty certificate must accompany the delivery, and samples must be tested pre-closure.

What are the technical specifications for IS/ISO 10555-5 catheters in this tender?

Proposed catheters must feature a vent fitting type with wings, an injection port integrated with the hub, and needle-stick protection. Compliance with IS/ISO 10555-5 (Part 5) and color coding per Table 1 is required. Lumen count and nominal outer diameter are specified in the product datasheet; packaging must be OEM original.

What is the delivery flow for quantity variation under this tender?

The purchaser may adjust quantity by ±25% at contract placement or during currency. Delivery time extensions are computed as (additional quantity ÷ original quantity) × original delivery period, with a minimum extension of 30 days, ensuring supplier readiness for fluctuating demand.

What licenses and certifications must the supplier provide for medical devices?

Suppliers must provide a valid Medical Device license from the competent authority and demonstrate MDR 2017 compliance. Also required are the Drugs and Cosmetics Act 1940 alignment, OEM warranty, and the ability to supply original OEM packaging with the requested catheter model.

How to submit a sample for technical suitability in this tender?

Submit a sample to Purnima Mandal, Assistant Nursing Officer, Divisional Railway Hospital, S.E. Railway, Kharagpur, Pin 721301 before tender closing. Failure to submit the sample leads to rejection. Ensure the sample matches the IS/ISO 10555-5 specifications and is accompanied by OEM documentation.

What are the color coding and safety features required for the catheter?

Catheters must follow color coding per Table 1 of IS/ISO 10555-5 and incorporate protection against accidental needle-stick injuries. The device must include an integrated injection port and an optional wings design, aligning with the specified safety and usability features.

Which authority regulates the medical device license for this tender?

The tender requires a valid Medical Device license issued by the competent authority under MDR 2017. Suppliers must provide a copy of the license and demonstrate ongoing regulatory compliance for the catheter products admitted under this procurement.

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