Requirements_Document.docx

ALP CDRH-2026-132857

MTC Load Cell Transducer Replacement

U.S. FOOD AND DRUG ADMINISTRATION

Statement of Work Load Cell Transducer Replacement Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics

1. Purpose This document states the technical and service requirements for the acquisition of one load cell transducer to replace the malfunctioning unit installed on the Government-owned MTS Mini-Bionix 858 materials testing system, load frame model 370.02. The acquisition includes fabrication of interface hardware, removal of the existing transducer, delivery, installation, on-site calibration, operational verification, technical documentation, and the contractor's standard commercial warranty.

2. Background The Division of Applied Mechanics within the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, uses the MTS Mini-Bionix 858 materials testing system to perform benchtop mechanical testing of orthopaedic and cardiovascular medical devices under static and cyclic tension, compression, and torsion. That testing requires a high-resolution, high-capacity load sensing device.

The currently installed load cell transducer is malfunctioning. Uninterrupted use of the system is required to maintain continuity of multiple ongoing research projects for which custom fixtures and custom test protocols have been designed to operate with this system. The resulting data supports the development of test standards and research relied upon by medical device manufacturers and other stakeholders.

3. Scope This acquisition includes:

1. One load cell transducer meeting the minimum requirements in section 4

1. Fabrication and provision of a load cell interface (top) plate and a load cell interface (bottom) adapter plate

1. All accessories, adapters, and interface hardware necessary for proper operation with the Government's existing load frame

1. Removal of the currently installed load cell transducer

1. Delivery to the site identified in section 7

1. Installation on the Government's existing load frame

1. On-site calibration in axial loading and in torque loading

1. Calibration certificates and operational verification

1. Technical documentation

1. The contractor's standard commercial warranty

1. All mileage, travel, and lodging costs associated with delivery, installation, and calibration The installation, fabrication, and calibration services are ancillary to the equipment purchase and are acquired as part of this supply action.

4. Minimum Requirements The load cell transducer shall be newly manufactured. It shall not be used, refurbished, reconditioned, remanufactured, or previously used for demonstration.

The load cell transducer shall meet the following minimum requirements:

1. Axial measurement range of at least 0 N to plus or minus 22,000 N in both tension and compression

1. Torsional measurement range of at least 0 Nm to plus or minus 200 Nm

1. Direct mechanical fit to the base of the Government's MTS Mini-Bionix 858 materials testing system, load frame model 370.02

1. Connection to the load frame controller through the available TDS connectors, or provision of a complete solution for interfacing with load frame model 370.02

1. Load and torque reporting functionality during testing equivalent to that provided by the currently installed load cell

1. All accessories necessary to ensure proper operation with load frame model 370.02

1. Operation on facility power: the load cell must connect to the existing load frame. Manufacturer: MTS. Model Number: 370.02. Serial Number: 10525599. Controller: FlexTest 60.

1. Compliance with all applicable Federal, state, and local safety standards Interface hardware to be fabricated The Contractor shall verify the dimensions and mounting configuration of the Government's existing equipment and shall fabricate and provide a load cell interface (top) plate and load cell interface (bottom) adapter plate necessary to provide a complete and fully operational solution.

1. 5. Calibration The contractor shall perform calibration on site at the Government facility housing load frame model 370.02, following installation. Calibration shall be performed in both axial loading and torque loading.

Calibration shall be performed in accordance with the following standards:

Force calibration to ASTM E4-21: 1% to 100% capacity Torque calibration to ASTM E2624-17: 1% to 100% capacity The contractor shall provide all relevant and necessary NIST-traceable calibration certificates.

6. Warranty The Government will accept the contractor's standard commercial warranty and will use that warranty for repair and replacement of the transducer. The warranty shall provide, at a minimum:

1. A full warranty of twelve (12) months from the date of final acceptance

1. Coverage of all parts, labor, travel, and technical support required to return the transducer to full operating condition

1. Technical support by telephone or email during standard business hours

7. Delivery, Removal, and Installation

1. The transducer shall be delivered to: 10903 New Hampshire Ave, Building 62, Room G216, Silver Spring, MD 20993

1. Delivery shall occur within six (6) weeks after award

1. The Contractor shall remove the currently installed load cell transducer from the Government’s MTS Mini-Bionix 858 system. Following removal, the existing load cell transducer shall remain Government property and shall be turned over to the COR or COR’s designee at the performance location.

1. Installation, calibration, and operational verification shall be completed at time of delivery

1. The Contractor is responsible for all setup, installation, calibration, and verification of system performance.

1. For all on-site work, Contractor personnel shall report to security at the performance site, who will contact the Contracting Officer's Representative (COR) or the COR's designee. Contractor personnel shall be escorted by the COR or the COR's designee at all times while on site

1. On-site work shall be performed between 9:00 a.m. and 5:00 p.m. Eastern Time, Monday through Friday, unless otherwise directed by the COR.

1. All mileage, travel, and lodging costs associated with delivery, installation, and calibration shall be included in the firm-fixed price

8. Deliverables

9. Government-Furnished Information The Government does not possess fabrication drawings for the required load cell interface (top) plate or load cell interface (bottom) adapter plate.

The Government will provide access to the existing MTS Mini-Bionix 858 materials testing system, load frame model 370.02, and existing fixtures as necessary for the Contractor to verify dimensions, mounting configurations, hole patterns, and other interface requirements necessary to fabricate and install the required interface hardware.

The Contractor shall be responsible for obtaining or verifying all measurements necessary to design and fabricate the required interface hardware and for providing all materials, labor, and equipment necessary to ensure proper fit and operation with the Government's existing equipment.

The Government will provide the following available equipment information:

· MTS Mini-Bionix 858 load frame, Model 370.02

· FlexTest 60 Controller

· Existing load and torque electrical interface information, including PT02E-10-6P connectors

· Existing load cell transducer: MTS Model 662.20H-05, Serial Number 10520690 All costs associated with measurement verification, fabrication, and installation of the required interface hardware shall be included in the Contractor's firm-fixed price.

10. Training and Post-Warranty Maintenance Operator training and post-warranty preventative maintenance are not required.

11. Holidays and Government Closures The contractor is not required to perform on-site services on the following Federal holidays, or on any other day designated as a holiday for the Washington, DC area:

1. New Year's Day

1. Martin Luther King Jr. Day

1. Presidents' Day

1. Memorial Day

1. Juneteenth National Independence Day

1. Independence Day

1. Labor Day

1. Columbus Day

1. Veterans Day

1. Thanksgiving Day

1. Christmas Day

1. Inauguration Day (every four years, for performance sites in the DC area)

12. Acceptance Criteria The Government will inspect and test the transducer upon installation. Final acceptance is based on:

1. Successful removal of the existing transducer and installation of the new transducer on load frame model 370.02

1. Successful on-site calibration in axial loading and in torque loading

1. Operational verification demonstrating load and torque reporting functionality equivalent to the prior configuration

1. Receipt of all calibration certificates and technical documentation

1. No outstanding deficiencies at the time of inspection The warranty period begins at final acceptance.

13. Points of Contact See the contract for points of contact.

Requirements Document | CDRH-2026-132857 | Page 1