Attachment 3_Requirements_and_Technical_Data_LargeTabletop.docx
DOCX document 22 KB Posted
- Attached to
- OCONUS Steam Sterilizers
- Solicitation number
- DHN-EURSterilizersFY26
- Issued by
-
Defense Health Agency
About this file
This is a technical specifications document for a large-capacity tabletop steam sterilizer (autoclave) that the Defense Health Agency seeks to procure for use at OCONUS facilities in the United Kingdom, Germany, and Turkey. The equipment must be FDA cleared/approved and CE marked as a medical device, with an exterior footprint not exceeding 26.0" W x 20.7" H x 34.5" D. The sterilization chamber must be at least 15 inches in diameter and 30 inches deep with a minimum volume of 84 liters, accommodating at least two trays of minimum dimensions 11" x 26" and 14" x 26", and supporting solid instrument loads of at least 14.0 lbs and textile/porous loads of at least 4.7 lbs.
The autoclave must feature pre-programmed sterilization cycles at 273°F (134°C) and 250°F (121°C) with dedicated programs for unwrapped instruments, wrapped instruments, porous loads, and glassware. Equipment must include closed-door forced-air drying with an air compressor and HEPA air filter (0.2 μm), with a drying cycle supporting a minimum of 30 minutes. Additional requirements include a minimum 7.5-liter mineral-free water reservoir compliant with EN 13060 water quality standards (maximum conductivity 15 μS/cm), cycle temperature documentation capability, safety interlocks preventing operation with improper door closure or insufficient water, system monitoring for cycle status and fault conditions, operation on 230 VAC single-phase 50/60 Hz drawing no more than 15 A, and a minimum 10-year warranty on the sterilization chamber with standard manufacturer warranty of at least two years for parts and labor.
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Other files
| File | Type | Posted |
|---|---|---|
| Attachment 1_Requirements_and_Technical_Data_ClassB.docx | DOCX document | |
| Attachment 2_Requirements_and_Technical_Data_FloorStanding_HospitalGrade.docx | DOCX document | |
| Sources Sought_OCONUS_Steam_Sterilizers.docx | DOCX document |
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Text version
Sterilization Autoclave (Large-Capacity Tabletop)
SPECIFICATIONS
Sterilization Autoclave (Large-Capacity Tabletop)
MARKET RESEARCH NOTICE — NOT A SOLICITATION
1. General Description / Scope The requirement is for a large-capacity table-top steam sterilizer (autoclave) for sterilizing medical and surgical instruments in healthcare facilities, supporting unwrapped solid instruments, wrapped instruments, porous loads, and glassware, with automated closed-door forced-air drying.
2. Pertinent requirements and technical characteristics The equipment offered must meet or exceed the following:
1. Regulatory Approval: The equipment offered must be FDA cleared/approved AND CE marked as a medical device for steam sterilization use.
1. Maximum Outside Dimensions: The offered equipment's exterior footprint must NOT EXCEED 26.0" W x 20.7" H x 34.5" D (660 mm x 525 mm x 875 mm). Smaller or equal dimensions are acceptable; larger dimensions in any axis are not.
1. EU Water Quality Standard: The offered equipment's steam generator water supply must comply with EN 13060 water quality requirements for steam sterilization.
1. Cycle Temperature Documentation: The offered equipment must have the ability to produce a printout (or equivalent permanent, retrievable digital record) detailing the temperature achieved during each sterilization cycle, for record-keeping and validation purposes.
1. Any product must meet or exceed the following specifications.
| Category |
| Parameter |
| Minimum Requirement / Specification |
| Physical Dimensions |
| Chamber Dimensions |
| Chamber must be at least 15 inches in diameter and 30 inches deep (approx. 38 cm x 76 cm), minimum volume of 84 liters. |
| Physical Dimensions |
| Exterior Dimensions |
| Exterior footprint must not exceed 26.0" W x 20.7" H x 34.5" D (660 x 525 x 875 mm). |
| Physical Dimensions |
| Tray Capacity |
| Must accommodate at least two trays with minimum dimensions of 11" x 26" and 14" x 26". |
| Physical Dimensions |
| Water Reservoir |
| Minimum mineral-free water reservoir capacity of 7.5 liters (2.0 US gal). |
| Performance |
| Load Capacity (Solid) |
| Minimum load capacity for solid instruments of 14.0 lbs (6.4 kg). |
| Performance |
| Load Capacity (Textile) |
| Minimum load capacity for textile/porous loads of 4.7 lbs (2.1 kg). |
| Sterilization Cycles |
| Temperature Profiles |
| Must provide pre-programmed cycles at 273°F (134°C) and 250°F (121°C). |
| Sterilization Cycles |
| Program Diversity |
| Must include dedicated programs for unwrapped instruments, wrapped instruments/porous loads, and glassware, plus an auxiliary drying-only program. |
| Air Removal & Drying |
| Drying Method |
| Must be equipped with an air compressor and HEPA air filter (0.2 µm) to perform a closed-door, forced-air drying cycle. |
| Air Removal & Drying |
| Drying Duration |
| Drying cycle time must support a minimum of 30 minutes. |
| Efficiency |
| Standby/Ready Mode |
| Must support a low-power standby heating mode between cycles to reduce subsequent cycle start-up time. |
| Water Quality |
| Feed Water Standard |
| Steam generator water supply must comply with EN 13060 water quality requirements (or equivalent), maximum conductivity 15 µS/cm. |
| Operation & Safety |
| System Monitoring |
| Must provide clear notifications for cycle status, including low water, low heat, low pressure, and high temperature conditions. |
| Operation & Safety |
| Safety Interlocks |
| Must prevent cycle start if the door is improperly closed or if water reservoir volume is insufficient. |
| Regulatory |
| Medical Device Certification |
| Must be FDA cleared/approved and CE marked as a medical device for steam sterilization; must comply with EN 13060 (Small Steam Sterilizers) and ISO 17665 (Moist Heat Sterilization). |
| Electrical |
| Power Supply |
| Must operate on 230 VAC, single-phase, 50/60 Hz, drawing no more than 15 A. |
| Warranty |
| Chamber Warranty |
| Sterilization chamber must carry a minimum 10-year warranty against defects in materials and workmanship. |
Warranty and Support
· Standard manufacturer warranty (minimum of two years for parts and labor) is required.
Delivery / Schedule
· Standard delivery and setup required.
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