📋 Basic Information
| Model NO. | BF-BI6 |
| Sterilization | Without Ethylene Oxide Sterilization |
| Quality Guarantee Period | Two Years |
| Group | All |
| Logo Printing | With Logo Printing |
| Sterile | Eo or Steam |
| Bacteria | G. Stearothermophilus |
| Method | Moist Heat Sterilization |
| OEM/ODM | Available |
| Content | Chemical Indicator Strip |
| Transport Package | 25PCS/Box |
| Specification | ATCC7953 |
| Origin | China |
| Production Capacity | 250000PCS/Day |
📊 Product Description
Steam Biological indicator is specially designed for monitoring steam sterilization processes. If the sterilization process is unsuccessful, after incubation at 60±2°C the color of the medium will change from purple to yellow or its shades, indicating the presence of still viable Geobacillus stearothermophilus (ATCC 7953) spores. If the sterilization process is successful, there will be no change in the color of the medium after incubation, it will remain in its original color. The last readout should be taken after 24 hours of incubation at 60±2°C.
- Do not use for ETO, dry heat, formaldehyde, hydrogen peroxide and other sterilization processes.
- Do not reuse the biological indicators.
Compliance Standards:
ISO 11138-1:2017
ISO 11138-3:2017
📖 Technical Specifications
| Product Name | Self-contained Biological Indicator for Moist Heat Sterilization |
| Type | BF-BI4 |
| Units per Pack | 25 pcs/box |
| Indicator Bacteria | G. stearothermophilus, ATCC7953 |
| Spore population | ≥1.0×10⁵ cfu |
| D-Value | ≥1.5min (Test condition: saturated steam 121ºC) |
| Incubation Time | 48h |
| Result Interpretation | Color Change in Bioassay culture medium: positive; No Color Change: negative |
| Certificates | ISO13485 |
📦 Product Content
Consists of medium in a glass ampoule, a disc inoculated with Geobacillus stearothermophilus (ATCC 7953) spores, a chemical indicator strip, a plastic tube, a plastic cap, and a filter paper inside the cap.
🚚 Packaging & Shipping
+ Other Medical Consumables
🏭 Manufacturing Capability
Equipped with professional production facilities established in 2015, operating across 100,000 square meters of factory space. We are one of the most professional disposable medical products suppliers.
Available supply includes: sterilization pouches & rolls, dental bibs, saliva ejectors, mixing tips, face masks, surgical gowns, dental kits, polishing brushes, micro brush applicators, barrier film, alcohol pads, oral foam swabs, surgical blades, and various orthodontic and medical disposables.
★ Our Advantages
Looking forward to cooperating with you in the future.
? Frequently Asked Questions
1. What sterilization process is this biological indicator suitable for?
This indicator is specifically designed for monitoring moist heat (steam) sterilization processes. It should not be used for ETO, dry heat, or formaldehyde processes.
2. How do I interpret the test results?
After incubation, if the medium color changes from purple to yellow, it indicates a failure (viable spores present). If it remains purple (original color), the sterilization process was successful.
3. What is the required incubation temperature and time?
The indicators should be incubated at 60±2°C. While the last readout is typically taken after 24 hours, the full incubation period for confirmed results is 48 hours.
4. What is the shelf life of the BF-BI6 indicators?
The product has a quality guarantee period of two years from the date of manufacture.
5. Which indicator bacteria are used in these vials?
They use Geobacillus stearothermophilus (ATCC 7953) spores with a population of ≥1.0×10⁵ cfu.
6. Does the product comply with international standards?
Yes, the biological indicators are in full compliance with ISO 11138-1:2017 and ISO 11138-3:2017 standards.
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