Attachment 2_Requirements_and_Technical_Data_FloorStanding_HospitalGrade.docx
DOCX document 21 KB Posted
- Attached to
- OCONUS Steam Sterilizers
- Solicitation number
- DHN-EURSterilizersFY26
- Issued by
-
Defense Health Agency
About this file
This is a technical requirements and specifications document for a floor-standing, hospital-grade steam sterilizer (autoclave) as part of the Defense Health Agency's market research for OCONUS steam sterilizer procurement. The document establishes minimum specifications that must be met or exceeded by any offered equipment.
The floor-standing sterilizer must be FDA cleared/approved and CE marked as a medical device, featuring a free-standing, cabinet-enclosed design mounted on wheels with a chamber minimum of 15 inches in diameter and 30 inches deep (84-liter minimum volume). The exterior footprint cannot exceed 28.4" W x 54.1" H x 46.5" D, and the unit must accommodate a minimum of two trays. The sterilizer requires an integral steam generator with a minimum 9 kW output independent of building steam supply, capable of delivering pre-programmed sterilization cycles at 273°F (134°C) and 250°F (121°C), with a minimum of five dedicated programs for various instrument types and delicate materials. Additional requirements include leak/vacuum test and Bowie & Dick steam penetration test programs, 24-hour delayed-start scheduling capability, EN 285 water quality compliance, Class I electrical protection, 380-400 VAC three-phase 50/60 Hz power operation, stainless steel chamber and door construction (316L minimum), permanent cycle documentation with USB and Ethernet connectivity, and a minimum two-year manufacturer warranty. This specification is one of three equipment categories being sourced for fourteen total units across DHA facilities in the United Kingdom, Germany, and Turkey, with preference for single-manufacturer sourcing.
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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 1_Requirements_and_Technical_Data_ClassB.docx | DOCX document |
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Text version
Sterilization Autoclave (Floor-Standing, Hospital-Grade)
SPECIFICATIONS
Sterilization Autoclave (Floor-Standing, Hospital-Grade)
MARKET RESEARCH NOTICE — NOT A SOLICITATION
1. General Description / Scope The requirement is for a free-standing, mobile, cabinet-enclosed, hospital-grade steam sterilizer with an integral steam generator, suitable for large medical/dental clinics and operating rooms, capable of high-throughput operation independent of building steam utilities.
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 28.4" W x 54.1" H x 46.5" D (72.1 cm x 137.5 cm x 118.1 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/condensate water supply must comply with EN 285 water quality requirements for steam sterilization (large steam sterilizer standard, applicable to this hospital-grade chamber classification).
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 28.4" W x 54.1" H x 46.5" D (72.1 x 137.5 x 118.1 cm). |
| Physical Dimensions |
| Mobility |
| Must be free-standing, cabinet-enclosed, and mounted on wheels (front and rear) for repositioning. |
| Physical Dimensions |
| Tray Capacity |
| Must accommodate a minimum of 2 trays. |
| Performance |
| Integral Steam Generator |
| Must include a built-in steam generator with a minimum output of 9 kW, independent of building steam supply. |
| 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 a minimum of 5 dedicated programs covering unwrapped instruments, wrapped instruments, wrapped pouches, and delicate (lower-temperature) unwrapped and wrapped instruments. |
| Sterilization Cycles |
| Test Cycles |
| Must include a leak/vacuum test program and a fixed-parameter Bowie & Dick (steam penetration) test program. |
| Scheduling |
| Delayed Start |
| Must support scheduling a cycle start up to 24 hours in advance. |
| Water Quality |
| Feed Water Standard |
| Steam generator and condensate water quality must comply with EN 285 (Large Steam Sterilizer) water quality requirements. |
| Operation & Safety |
| Electrical Protection Class |
| Must provide Class I protection against electrical shock. |
| Operation & Safety |
| Cycle Documentation |
| Must produce a retrievable, permanent record (printed or digital) of cycle date, time, serial number, cycle type, sterilization temperature, sterilization time, and dry time; must provide USB and network (Ethernet) connectivity for data access. |
| Regulatory |
| Medical Device Certification |
| Must be CE marked as a medical device under the applicable EU Medical Device Directive/Regulation and comply with EN 285 (Large Steam Sterilizer) and EN ISO 17665-1 (Moist Heat Sterilization). |
| Electrical |
| Power Supply |
| Must operate on 380–400 VAC, 3-phase, 50/60 Hz (or a documented equivalent voltage configuration for the intended installation site). |
| Construction |
| Materials |
| Chamber and pressure vessel must be constructed of stainless steel (minimum 316L or equivalent); door must be stainless steel. |
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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