B01-HT942726QE005-Attach1-CODs-CLS-APPs-20250922-Final.pdf

HT942726QE001 – Attachment 1

REQUIREMENTS DOCUMENT:

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

(APPs)

Title: Surgical Sterilizer

Requiring Activity/ Agency Name: Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices (SMD)

Background: The Army requires a new surgical sterilizer to be used in deployed dentistry, veterinary, medical and laboratory sets (Role of Care 2). While the current device is still procurable, its initial procurement year was 2006 and therefore is nearly two decades behind the current state of the art while also being priced at a point that makes it unaffordable. Without a suitable replacement, the Army's ability to provide effective sterilization in forward-deployed settings will be compromised, impacting Warfighter readiness. The new surgical sterilizer must meet the specifications detailed below.

Purpose: The government anticipates awarding a single contract for four (4) surgical sterilizers to include options for three (3) additional surgical sterilizers. These units will undergo operational testing conducted by the Medical Test Evaluation Activity and environmental testing in accordance with Military Standard (MIL-STD) 810-H (1), Department of Defense, Test Method Standard, Environmental Engineering Considerations and Laboratory Tests.

Government Intent: Following successful operational and environmental testing, in Fiscal Year (FY) 2028, the government intends to procure an estimated 711 surgical sterilizers over a period of up to five years. To streamline delivery to the warfighter, the selected vendor will be highly encouraged to collaborate with the Defense Logistics Agency (DLA) to incorporate the surgical sterilizer into the Electronic Catalog (ECAT).

ECAT is the Department of Defense's primary online procurement system, providing access to millions of items with associated National Stock Numbers (NSNs). Listing the device on ECAT will ensure efficient ordering, tracking, and standardized access for all branches of the military. Vendors can find information on working with ECAT at https://www.dla.mil/Troop-Support/Medical/ECAT/.

For specific ECAT-related questions, please contact the ECAT Help Desk at dscpecathelp@dla.mil.

https://www.dla.mil/Troop-Support/Medical/ECAT/ mailto:dscpecathelp@dla.mil

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

1.Critical Operational Device Specifications: The following 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

Food and Drug Administration (FDA) Regulatory Oversight

The Surgical Sterilizer 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 Core Function

The Surgical Sterilizer shall be able to sterilize all surgical instrumentations necessary to perform clinical procedures and surgeries.

Minimum Requirement

3 Chamber Size Compatibility

The Surgical Sterilizer shall have a chamber size of 12.0” dia. x 23.5” long 1.6 ft (3).

Desired Characteristics size of the chamber is 13.5” dia. x 24" long 2.0 ft (3)

4 Operating Temperature range

The Surgical Sterilizer shall have an operating temperature range of 35°F to 130°F (1.7°C to 54°C).

Minimum Requirement

5 Sterilization temperature

The system shall have an exposure temperature Range (°F/°C) 250/121- 275/135.

Minimum Requirement

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

Characteristic Minimum Required Desired Characteristics

6 Tray Dimensions The tray shall fit standard wrapped sterilization trays with outside dimensions of 6.7”x 16.3”x 0.8.”

Desired Characteristics of the Surgical Sterilizer fits full-length rigid sterilization containers with outside dimensions of 23.1” x 12.4” x 8.4.”

7 Tray material The tray shall be made of stainless steel. Minimum Requirement

8 Indicator Light The Surgical Sterilizer shall have a power light, heat light and dry light. Minimum Requirement

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

Characteristic Minimum Required Desired Characteristics

9 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.

* Note: Balanced power is a process that eliminates noise or distortion from incoming electrical current.

Minimum Requirement

10 Operational Cube and Weight

The system shall have operational dimensions of 4 cu ft, 35 lbs.

Desired characteristic of the system dimensions 9 cu ft, 95 lbs.

11 Water quality/ conservation

Unit requires a Distilled Water Generator. Minimum Requirement

12 Maximum relative humidity

The Surgical Sterilizer shall have a relative humidity of 80%, non-condensing.

Desired Surgical Sterilizer has relative humidity less than 90%, non-condensing

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

2. Critical Logistical Specifications: The following 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.

# Logistical Characteristic Minimum Required Desired Characteristics

1 Trade Agreements Act (TAA) Compliance

The device, accessories, and repair parts must be compliant with the Trade Agreements Act (TAA).

The vendor is required to complete and submit the DFARS Provision 252.225-7020, Trade Agreements Certificate.

Minimum Requirement

2 Repair Parts Support

The vendor must provide a comprehensive list of all repair parts, clearly identifying those deemed high-failure items (as determined by the Original Equipment Manufacturer (OEM) and government subject matter experts).

For each part, the list must specify availability, whether it is proprietary, and how it can be procured.

Minimum Requirement

3 Maintenance Requirement

The device shall not have any proprietary-scheduled maintenance actions that occur more than once per year.

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

Characteristic Minimum Required Desired Characteristics

4 Special Tools

The vendor must identify any specialized tools required for repair or maintenance of the equipment and make these tools available for purchase.

The Surgical Sterilizer doesn’t require special tools for maintenance or repairs.

5 Manuals

For each system delivered, the vendor must provide one physical and one digital copy of both the User/Operator Manual and the Maintenance/Service Manual.

Minimum Requirement

6 Training

The vendor shall provide a one time in person, onsite training to both operators and maintainers (maintenance training), for 5-10 people, at specified contiguous United States (CONUS) government location.

Minimum Requirement

Risk Management Framework (RMF) / Authority to Operate

(ATO)

The vendor shall complete the provided documentation required by the Government to complete Risk Management Framework (RMF) procedures and Authority to Operate (ATO) activities for cybersecurity protections.

Minimum Requirement

8 Copyright Release

The vendor shall provide an operational and maintenance copyright/ distribution release for supporting Army technical manuals to be distributed throughout the force.

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

Characteristic Minimum Required Desired Characteristics

9 Reusable Harden Transport Case

The Surgical Sterilizer shall be configured in one or multiple reusable hardened transport cases (i.e. pelican or harden) with protective foam, designed to meet military standard MIL-STD810H (1) Paragraph:

• 501.7 High Temperature

• 502.7 Low Temperatures

• 506.6 Rain

• 514.8 Vibration

• 516.8 Shock

Minimum Requirement

10 Warranty The vendor shall provide a one (1) year manufacturer warranty. Minimum Requirement

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

Characteristic Minimum Required Desired Characteristics

11 Packaging

The vendor shall provide the Surgical Sterilizer with all its components and accessories packed safely and securely in self-contained hardcases. The cases shall have approved marked data plates with the following information:

• Item Unique Identification

(IUID) on each system/unit, in accordance with Defense Federal Acquisition Regulation Supplement 252.211-7003, IUID and Valuation

• Shall include a list of case contents with picture showing location and position of item in the case.

Inserts shall be of closed-cell foam, or similar insulation, and protective material capable of sustaining the system throughout transport and environmental conditions.

Minimum Requirement

12 Delivery The vendor shall deliver the Surgical Sterilizer system 120-150 days after award.

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter

3. Additional Performance Parameter: The following are additional performance parameters that are not required, but desired by the government.

# Additional Performance Parameter Desired Characteristic

1 Support of Device

For possible future purchases, if the vendor’s device is selected following the down-section process, the vendor will ensure the devices are able to be procured for a minimum of five years and will support the parts for an additional five years. The vendor shall provide supportability, including maintenance, technical documentation, components and access to OEM or government-provided sustainment support.

2 Defense Logistics Agency, Electronic Catalog (ECAT)

The vendor currently has a DLA ECAT contract or is willing to work with a Prime Vendor to get the device added to electronic catalog (ECAT) to provide a process that streamlines the procurement, allowing users to easily search for items, place orders, and track shipments, ultimately saving time and money while ensuring all branches have access to the same standardized products.