Attachment 1_Requirements_and_Technical_Data_ClassB.docx
DOCX document 23 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 Class B tabletop steam sterilizer (autoclave) required by the Defense Health Agency for OCONUS facilities in the United Kingdom, Germany, and Turkey. The equipment must be FDA cleared/approved and CE marked as a medical device, with regulatory compliance to EN 13060 and ISO 17665 standards. The sterilizer must accommodate wrapped and unwrapped solid instruments, porous/textile loads, and dental handpieces, featuring a fractionated pre-vacuum air removal system with post-cycle vacuum drying performed with the chamber door closed. Physical dimensions must not exceed 19.7" W x 19.7" H x 23" D with a minimum chamber volume of 27 liters and capacity for at least 5 instrument trays.
The equipment must meet specific performance requirements including minimum load capacities of 19.8 lbs for unwrapped solids, 11.9 lbs for wrapped solids, and 4.4 lbs for textile/porous loads, with accommodation for a minimum of 5 dental handpieces per cycle. The sterilizer must provide both Class B and Class S cycle types with pre-programmed temperature profiles at 273°F (134°C) and 250°F (121°C), dedicated programs for various load types, and comprehensive cycle documentation capability storing a minimum of 1,000 cycle records with retrievable temperature, pressure, and time data. Additional requirements include dual independent door interlock confirmation, safety thermostat/pressure relief protection rated at or below 40.6 PSI, 230 VAC single-phase 50/60 Hz power supply drawing no more than 12 A, and steam generator water supply compliant with EN 13060 water quality standards with maximum conductivity of 15 μS/cm. A minimum two-year manufacturer warranty for parts and labor is required.
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Other files
| File | Type | Posted |
|---|---|---|
| Sources Sought_OCONUS_Steam_Sterilizers.docx | DOCX document | |
| Attachment 3_Requirements_and_Technical_Data_LargeTabletop.docx | DOCX document | |
| Attachment 2_Requirements_and_Technical_Data_FloorStanding_HospitalGrade.docx | DOCX document |
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Text version
Sterilization Autoclave (Class B Tabletop)
SPECIFICATIONS
Sterilization Autoclave (Class B Tabletop)
MARKET RESEARCH NOTICE — NOT A SOLICITATION
1. General Description / Scope The requirement is for a Class B table-top steam sterilizer (autoclave) for sterilization of medical/dental instruments, including wrapped and unwrapped solid instruments, porous/textile loads, and dental handpieces, for immediate use or storage. The device must provide fractionated pre-vacuum air removal and post-cycle vacuum drying performed with the chamber door closed.
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 19.7" W x 19.7" H x 23" D (50 cm x 50 cm x 58 cm). 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 11 inches in diameter and 18 inches deep (approx. 28 cm x 46 cm), minimum usable volume of 27 liters. |
| Physical Dimensions |
| Exterior Dimensions |
| Exterior footprint must not exceed 19.7" W x 19.7" H x 23" D (50 x 50 x 58 cm). |
| Physical Dimensions |
| Tray Capacity |
| Must hold a minimum of 5 instrument trays. |
| Performance |
| Load Capacity (Solid, Unwrapped) |
| Minimum load capacity for unwrapped solid instruments of 19.8 lbs (9.0 kg). |
| Performance |
| Load Capacity (Solid, Wrapped) |
| Minimum load capacity for wrapped solid instruments of 11.9 lbs (5.4 kg). |
| Performance |
| Load Capacity (Textile/Porous) |
| Minimum load capacity for textile/porous loads of 4.4 lbs (2.0 kg). |
| Performance |
| Handpiece Capacity |
| Must accommodate a minimum of 5 dental handpieces per cycle in a dedicated handpiece program. |
| Sterilization Cycles |
| Classification |
| Must provide both Class B (fully wrapped, porous, and hollow loads) and Class S (manufacturer-validated load types) cycle types. |
| 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/pouched instruments, delicate (lower-temperature) instruments, and dental handpieces. |
| Air Removal & Drying |
| Air Removal Method |
| Must be equipped with a fractionated pre-vacuum (multi-pulse) air-removal system to ensure steam penetration of porous and hollow loads. |
| Air Removal & Drying |
| Drying Method |
| Must perform post-sterilization vacuum drying with the chamber door closed. |
| 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 |
| Door Interlock |
| Must provide a minimum of two independent means of confirming the door is fully closed before steam is introduced, plus a lock preventing door opening during operation. |
| Operation & Safety |
| Over-Temperature/Pressure Protection |
| Must include a safety thermostat/cutoff to prevent chamber over-heating and a safety pressure relief valve rated at or below 40.6 PSI (2.8 bar). |
| Operation & Safety |
| Cycle Documentation |
| Must produce a retrievable, permanent record (printed or digital, exportable via USB or network) of cycle temperature, pressure, and time for each sterilization cycle, retaining a minimum of 1,000 cycle records. |
| 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 12 A. |
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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