RFI Attachment 1 CODS Surgical Sterilizer.pdf
PDF 154 KB Posted
- Attached to
- Sterilizer, Surgical Instrument
- Solicitation number
- Not on record
- Issued by
-
Department of the Army Medical Command
About this file
This is a Critical Operational Device Specification (CODS) document detailing the requirements for a surgical sterilizer procurement. The specifications outline both minimum and desired characteristics across 13 operational requirements and 5 logistical requirements.
Key operational specifications include: FDA clearance requirements (510(k) for Class II or FDA registration for Class I), minimum chamber size of 12.0" dia. x 23.5" long, operating temperature range of 35°F to 130°F, sterilization temperature range of 250/121-275/135°F/°C, and power supply requirements supporting both 110-120 VAC 60Hz and 220-240 VAC 50Hz with auto-detection. The system must be Trade Agreements Act compliant and include critical logistical elements such as a 1-year minimum warranty (3 years desired), comprehensive repair parts support, physical and digital manuals, hardened transport cases meeting specific MIL-STD testing requirements, and video training capabilities. The device must be capable of sterilizing all surgical instrumentation necessary for clinical procedures and surgeries, with specifications for tray dimensions, materials, and humidity tolerance. The system should have operational dimensions of 4 cu ft and weigh 35 lbs, with desired specifications of 9 cu ft and 95 lbs.
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| File | Type | Posted |
|---|---|---|
| RFI Attachment 2 Company and Product Information Surgical Sterilizer.pdf |
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Text version
Attachment 1
Critical Operational Device Specification (CODS)
Critical Specifications: The below are critical specifications and the minimum must be met in order for the device to be considered acceptable by the government. They are separated by “minimum” and “desired” columns.
Instructions: Indicate “yes” or “no” under both minimum and desired columns below.
Additional comments may be added.
1. Critical Operational Device Specifications
Num ber
Operational
Characteristic Minimum Required Desired
Characteristics
Meets Minimum
Y/N?
Meets Desired
Y/N? Comments
Food and Drug Administration (FDA) Regulatory Oversight
The 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
N/A
2 Core Function
The Sterilizer shall be able to sterilize all surgical instrumentation s necessary to perform clinical procedures and surgeries.
Minimum Requirement
N/A
3 Chamber Size
The sterilizer shall have a chamber size of 12.0” dia. x 23.5” long
1.6 ft(3)
Desired Characteristi cs size of the chamber is 13.5” dia. x 24" long
2.0 ft(3)
Operating Temperature range
The sterilizer shall have an operating temperature range of 35°F to 130°F (1.7°C to 54°C)
Minimum Requirement
N/A
5 Sterilization Temperature
The Sterilizer shall have an exposure temperature Range of (°F/°C) 250/121- 275/135
Minimum Requirement
Tray Dimensions
The sterilizer shall fit standard wrapped sterilization trays with outside dimensions of 6.7” x 16.3” x 0.8”
Desired Characteristi cs of the 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
N/A
8 Indicator Light
The sterilizer shall have a power light, heat light and dry light.
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.
N/A
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.
Water quality/ conservation
Unit requires a Distilled Water Generator
N/A
Maximum relative humidity
The sterilizer shall have a relative humidity 80%, non-condensing.
Desired characteristic sterilizer has relative humidity least than 90%, non-condensing
Trade Agreements Act (TAA) Compliance
The Sterilizer and parts shall be compliant with TAA regulations.
2. Critical Logistic Specifications
Number
Operational
Characteristic Minimum Required Desired
Characteristics
Meets Minim um Y/N?
Meets Desired
Y/N? Comments
Repair Parts Support
Contractor 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.
2 Warranty
The contractor shall provide a warranty for at least (1) year. This warranty shall include all parts, In-House labor, and technical support during the warranty period
Desired the contractor provides a warranty for at least 3 years.
This warranty shall include all parts, In-house labor, and technical support during the warranty period.
3 Manuals
The vendor shall provide 1 physical and 1 digital User and Operator Service Manuals with each system
Minimum Requirement
N/A
4 Reusable Harden Transport Case
A.) The system and all accessories should be
Requirement N/A securely contained in harden reusable transport cases (e.g.
Hardigg, Pelican, ECS Case or Equivalent).
B.) The system should be designed to withstand MILSTD testing in accordance with (IAW) the following paragraphs:
501.7 High Temperature
502.7 Low Temperature 507.6
Humidity
511.7 Explosive Atmosphere
514.8 Vibration
516.8 Shock
517.3 Pyroshock
528.1 Mechanical Vibrations of
Shipboard Equipment (Type I- Environmental and Type II- Internally Excited)
5 Training
The vendor shall provide video training on the use of the surgical sterilizer and
The vendor provides service and maintenan ce training at 3 training events for 5 people
(End of CODS)
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