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304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals 304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals
304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals 304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals
304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals 304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals
304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals 304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals
304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals 304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals

304 Stainless Steel Ethylene Oxide Sterilizer with CE FDA ISO13485 Certification for Hospitals

US$ 14550.00 ~ 38660.00
Min.Order: 1
Product origin: Hefei, Anhui, China
Category: Medical Equipment
Product Name: Medical Equipment
Availability:In Stock
Product Review : 58 Reviews
Infringement complaint:
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  • Model : SD-E3 (3m³) / SD-E6 (6m³)
  • Heating Method : Electric heating
  • Power Supply : AC380V, 50Hz
  • Power Consumption : 14KVA / 29KVA
  • Chamber Dimensions : 222×96×142cm / 335×120×150cm (L×W×H)
  • Machine Size : 240×272×218cm / 355×315×230cm (L×W×H)
  • Material : 304 stainless steel
  • Sterilization Temperature : 50°C ±3°C
  • Working Pressure : -50kpa
  • EO Gas Type : Blend EO gas (80%EO, 20% CO2)
  • Sterilization Time : 5-12 hours (adjustable)
  • Aeration System : Automatic air change with programmable settings
  • Documentation : Built-in printer for sterilization records
  • Certifications : CE, FDA, ISO13485
  • Instrument Classification : Class II
  • Control System : Siemens PLC with color LCD display

We've gone with SD-E6 model for the main hospital building — the 6m³ chamber at 335×120×150cm handles their endoscope sets and heat-sensitive plastic devices in a single cycle, roughly 200 trays per run, and the 3m³ unit for the outpatient wing is better suited for smaller batches of rubber tubing and catheters, where the 14KVA draw on a 380V supply is easier to manage given their existing electricla load.

Ethylene Oxide Sterilizer Front View

What it does is slowly circulate a blend of 80% ethylene oxide and 20% CO2 at 50°C ±3°C under -50kpa — not exactly high-pressure steam autoclave, but that's the point for anything that can't take heat — and the sterilization time runs anywhere from 5 to 12 hours depending on how tightly the items are packed and the bioburden.

Sterilizer Control Panel

The Siemens PLC with the color LCD makes it pretty straightforward for the technicians to set programs, and the built-in printer gives us a hard record for each cycle — most buyers go with the 6kg gas consumption per cycle for the larger unit, but you'll need to confirm your EO gas supplier can handle the 80/20 mix since some only stock 100% EO.

Sterilizer Internal Chamber

Also worth noting that the chamber is all 304 stainlss steel, which holds up better than 201 for repeated sterilization cycles, and the automatic aeration system runs programmable air changes to clear residual gas — the hospital's infection control team specifically asked for that feature, so it's not just a nice-to-have.

Sterilizer Operation

One thing I'd flag is that this isn't for sterilizing liquids or anything with a closed lumen longer than about 120cm (usually 2-4 weeks lead time on the SD-E6) — the EO penetration drops off in very narrow channels, so they'll still need a separate low-temp hydrogen peroxide system for flexible endoscopes with tiny working channels.

Sterilizer Documentation System

We usually have stock on the 3m³ model, but confirm lead time for the larger one — the CE and FDA marks are on file with the suplier, and the ISO13485 cert covers the manufacturing line, so the compliance paperwork is done, just make sure the hospital's biomedical engineering team reviews the power requirments before instalation.

Frequently Asked Questions

What are the sterilization chamber dimensions for the SD-E3 and SD-E6 models?

The SD-E3 has a chamber of 222×96×142cm, and the SD-E6 is 335×120×150cm. Make sure your facility can fit the machine size too, which is larger than the chamber.

What is the minimum order quantity for this sterilizer?

Our standard MOQ is 1 unit for these models, but we can discuss bulk orders if you need multiple units. Just reach out to us.

Do you provide the CE, FDA, and ISO13485 certificates with the shipment?

Yes, we include all three certifications—CE, FDA, and ISO13485—with every unit. You'll get the hard copies and digital files for your records.

How much EO gas does each cycle consume for the two models?

The SD-E3 uses about 3kg per cycle, and the SD-E6 uses 6kg. Both run on blend EO gas (80% EO, 20% CO2).

What is the typical lead time for delivery?

Lead time is usually 30-45 days after order confirmation, depending on your location and current production schedule. We'll give you a precise estimate once we know the shipping address.

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