Requirement Doc_ Biological Safety Cabinet v 27 MAY 2025.docx
DOCX document 42 KB Posted
- Attached to
- Biological Safety Cabinet
- Solicitation number
- W81K0425QF8589
- Issued by
-
Department of the Army Medical Command
About this file
This document is a Requirements Document for a Biological Safety Cabinet issued by Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices (SMD). The requirements specify a Class II, Type A/A2 Biological Safety Cabinet with critical operational and logistical specifications, including FDA regulatory oversight, NSF/ANSI 49-2018 standard compliance, and specific technical parameters such as a front-loading HEPA filter, dual non-glare fluorescent lights, and a 29" high work area.
Key additional requirements include Trade Agreements Act (TAA) compliance, comprehensive repair parts support, provision of user and maintenance manuals, and potential support for Defense Logistics Agency Electronic Catalog (ECAT) integration. The device is intended for laboratory use, specifically for processing environmental and clinical samples containing biological endemic and biological warfare agents. Vendors must provide documentation for Risk Management Framework procedures, copyright release for Army technical manuals, and optional stand for tabletop use. The solicitation (W81K0425QF8589) is issued by the Department of the Army Medical Command and seeks a biological safety cabinet that meets stringent operational and safety specifications.
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| File | Type | Posted |
|---|---|---|
| EBOM Biological Safety Cabinet RC signed.xlsx | XLSX spreadsheet |
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Text version
Requirements Document Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter (APPs)
Title: Biological Safety Cabinet
Requiring Activity/ Agency Name: Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices (SMD)
1. Critical Operational Device Specifications: The below are essential characteristics and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.
| # |
| Operational Characteristic |
Minimum Required
Desired Characteristics
Meets Minimum Y/N?
| 1 |
| Food and Drug Administration (FDA) Regulatory Oversight |
The Biological Safety Cabinet shall be cleared by the FDA with a 510(k) approval if it is a Class II medical device.
If the system is a Class I medical device, it shall be registered with the FDA for human use.
Minimum Requirement
| 2 |
| NSF International Standard / American National Standard Biosafety Cabinetry (NSF/ANSI 49-2018) |
The Biological Safety Cabinet shall meet the NSF/ANSI 49-2018 standard for Biosafety Cabinetry: Design, Construction, Performance, and Field Certification.
Minimum Requirement
| 3 |
| Biosafety Classification |
Level The Biological Safety Cabinet shall have a Class II, Type A/A2 classification level.
Minimum Requirement
| 4 |
| Viewing Panel |
The Biological Safety Cabinet shall contain a viewing panel that hinges and is also removable.
Minimum Requirement
| 5 |
| Viewing Window |
The Biological Safety Cabinet shall contain a contoured front window.
Minimum Requirement
| 6 |
| Filter |
The Biological Safety Cabinet filter must be a front-loading HEPA.
The supply and exhaust HEPA filters must be parallel to work area and prevent turbulence
Minimum Requirement
| 7 |
| Lights |
Dual, non-glare fluorescent lights
Minimum Requirement
| 8 |
| Controls |
Isolated switched power for blower and lighting
Minimum Requirement
| 9 |
| Weight |
The system shall weigh no more than 270 lbs.
The system shall weigh no more than 150 lbs.
| 10 |
| Work environment |
The device will have a 29" high work area
Minimum Requirement
| 11 |
| Power |
The power supply shall provide a balanced power source for the device, supporting both 110-120 VAC, 60Hz, and 220-240 VAC, 50Hz. It must include auto-detection and simultaneous switching capability between both voltage ranges. Additionally, if battery charging is necessary, the device must support charging for both voltage ranges.
Minimum Requirement
2. Critical Logistic Specifications: The below are essential logistical characteristics and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.
Operational Characteristic
Minimum Required
Desired Characteristics
Meets Minimum Y/N?
| 1 |
| Trade Agreements Act (TAA) Compliance |
The Biological Safety Cabinet and repair parts shall be compliant with TAA regulations.
The vendor must complete the attached TAA compliant sheet (see attachment 4_ TAA Compliant Verification) Minimum Requirement
| 2 |
| Repair Parts Support |
| The Vendor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list. |
| Minimum Requirement |
| 3 |
| Manuals |
| The vendor shall provide 1 physical and 1 digital User/Operator and 1 physical and 1 digital Maintenance/Service Manual with each system procured. |
| Minimum Requirement |
| 5 |
| Risk Management Framework RMF/ Authority to Operate (ATO) |
| The vendor shall provide supporting documentation as required by the client to complete Risk Management Framework procedures and Authority to Operate activities for cybersecurity protections if deemed relevant |
| Minimum Requirement |
| 6 |
| Copywrite Release |
| The vendors will provide an operational and Maintenance copyright/ distribution release for supporting Army Technical manuals to be distributed throughout the force. |
| Minimum Requirement |
| 7 |
| Stand |
| The vendor shall provide the option of a stand if the device is meant for tabletop use |
| Minimum Requirement |
3. ADDITIONAL PERFORMANCE PARAMETERS: The below are non-essential additional characteristics that the government desired but not required to be deemed acceptable
| Number |
| Additional Performance Parameters (APPs) |
| Additional Performance Parameters |
| 1 |
| Defense Logistics Agency Electronic Catalog (ECAT) |
| The vendor shall work with DLA troop support to get their products on the ECAT contract vehicle for future procurement and make available any service contracts ECAT as well |
| 2 |
| maintenance kits. |
| If requested by the client, the vendor shall work on creating maintenance kits. |
| 3 |
| manufacturing capability, order quantities and schedule |
| The vendor will provide information on manufacturing capability to help support the client in understanding supportable order quantities and schedule |
| 4 |
| Test, Measurement, Diagnostic, and Evaluation Equipment |
| The vendor will inform the client if there's any test, measurement, diagnostic, and evaluation equipment associated with the device. |
| 5 |
| Maintenance/service manuals |
| The vendor will, upon request, work with the client on identifying tasks within the maintenance/service manuals that can be conducted by the client and identify which tools are needed. |
| 6 |
| Training |
| The vendor can provide in person training or video training on the use of the Biological Safety Cabinet. |
Minimum Requirement
***End of Requirements Document***
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