Standard Specifications of Blood Cell Separator - Apheresis Machine

U-16/30/9/2010-Procell/TN/32-Part(1)/E-396447 08-06-2026

To All Deans - ESIC PGIMSRs, Medical & Dental Colleges and Hospitals All Medical Superintendents - ESIC Hospitals Director (Medical) Delhi/Director (Medical) Noida

Subject: Standard specifications of Blood Cell Separator - Apheresis Machine.

Respected Sir/Madam,

Reference captioned subject, please find enclosed herewith specifications and cost estimation in respect of Blood Cell Separator - Apheresis Machine recommended by duly constituted committee (comprising of experts from ESIC Institutions as well as external experts from premier/other Government Institutions) and approved by Director General, ESIC for utilization by ESIC Institutions

The approximate cost as per the specifications annexed (enclosed) is detailed below

All ESIC Institutions are hereby informed to adhere to the specifications and guidelines as detailed below:

A. The specifications are broad-based for use by ESIC Institutions. Considering technological developments, institutions may incorporate generic technical modifications and additional tender conditions after assessing local requirements, in strict adherence to the ESIC Medical Equipment Manual and all applicable procurement guidelines (GeM/GFR/CVC/MII) and statutory provisions.

B. The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare (MoH&FW) in the Central Government, from time to time.

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C. Where no relevant standard of any medical device has been laid down by the Bureau of Indian Standards or notified by the Ministry of Health and Family Welfare (MoH&FW) in the Central Government, such device shall conform to the standard laid down by the International Organization for Standardization (ISO) or the International ElectroTechnical Commission (IEC), or by any other pharmacopoeial standards.

D. In case of the standards which have not been specified by BIS/MoH&FW/ISO/IEC, or by any other pharmacopoeial standards, the device shall conform to the validated manufacturer’s standards.

E. All user units shall ensure evaluation of cost–benefit analysis, obtain necessary sanctions/approvals from Hqrs., and confirm adherence to ESIC norms, Delegation of Powers, infrastructure and manpower availability, and budgetary provisions before procurement.

F. Since GeM is dynamic in nature, institutions must conduct due diligence in cost estimation prior to tendering. Cost references should primarily be drawn from GeM contracts/supply orders; where unavailable, market surveys or other prescribed methods (GEM/ Equipment Manual/Manual of Procurement of Goods) may be used.

G. Procuring institutions must carefully assess whether the prescribed specifications are essential, or whether lower-specification equipment at a lower cost may adequately meet requirements, considering bed strength, ancillary facilities, location, and market conditions. Institutions must use GeM for cost estimation with appropriate specifications accordingly.

H. In cases where the estimated cost exceeds Delegation of Powers or is outside ESIC norms, or exceeds the cost estimated by ESIC Hqrs, the Dean/Medical Superintendent shall seek prior in-principle approval from Hqrs with proposals submitted in the prescribed proforma along with full justification, cost–benefit analysis, recommendations, and certification from local Finance & Accounts.

I. A pre-bid meeting/conference should invariably be conducted by the procuring location. During the course of the pre-bid meeting, if any clause within the specifications framed by ESIC Headquarters is found to be restrictive in nature, such clauses may be amended or removed, provided that the reasons for doing so are duly recorded. The technical evaluation shall thereafter be carried out based on the revised specifications and applicable criteria. Any such modifications must be promptly communicated to the Procurement Cell, ESIC Headquarters.

It is reiterated that the Head of the Institution shall be solely responsible to ensure that procurement is carried out strictly in compliance with ESIC norms, Government of India procurement guidelines (GeM/GFR/CVC/MII), and the ESIC Medical Equipment Manual.

User institutions must ensure that:

1. Only generic non-brand-specific specifications are adopted and strictly aligned with actual requirements.
2. Adequate budget, infrastructure and manpower are available.
3. Prior approval for starting services is obtained from ESIC Hqrs.
4. Cost–benefit analysis, reasonableness of rates (certify price reasonability by issuing/recording a formal Price Reasonability Certificate/report after the finalization of the bid) and optimum utilization are ensured.

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5. Local financial concurrence/vetting is obtained.
6. No user institution should issue letters of credits, rather wherever services are a component of procurement, the payment terms should be accordingly modelled.
7. Under no circumstances does any procured equipment remain unutilized.

This issues with the approval of Director General, ESIC.

Yours sincerely,

Dy. Medical Commissioner (RC & PC)

Encl: Standard specifications of Blood Cell Separator - Apheresis Machine

Copy to:

1. All Zonal Medical Commissioners.
2. PPS to DG/CVO/FC and PPS to MC(MA)/MC(ME)/MC(MS)/MC(PC).
3. WCM, Hqrs with request for uploading on ESIC website

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