Biological Indicator
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Vaporized Hydrogen Peroxide Biological Sterilization
Vaporized Hydrogen Peroxide Biological Sterilization is a highly effective and versatile method for sterilizing sensitive medical devices, equipment, and environments. It combines efficacy, material compatibility, and environmental safety, making it an ideal choice for many sterilization needs in healthcare, pharmaceuticals, and laboratory settings.
●Process: Hydrogen Peroxide
●Microorganism: Geobacillus stearothermophilus (ATCCR@ 7953)
●Population: 10^6 Spores/carrier
●Read-Out Time: 20 min, 1 hr, 48 hr
●Regulations: ISO13485: 2016/NS-EN ISO13485:2016
●ISO11138-1: 2017; BI Premarket Notification[510(k)], Submissions, issued October 4,2007
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Steam Sterilization Biological Indicators
Steam Sterilization Biological Indicators (BIs) are devices used to validate and monitor the effectiveness of steam sterilization processes. They contain highly resistant microorganisms, typically bacterial spores, which are used to test whether the sterilization cycle has effectively killed all forms of microbial life, including the most resistant strains.
●Microorganism: Geobacillus stearothermophilus(ATCCR@ 7953)
●Population: 10^6 Spores/carrier
●Read-Out Time: 20 min, 1 hr, 3 hr, 24 hr
●Regulations: ISO13485:2016/NS-EN ISO13485:2016 ISO11138-1:2017; ISO11138-3:2017; ISO 11138-8:2021
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Formaldehyde Sterilization Biological Indicator
Formaldehyde Sterilization Biological Indicators are crucial tools for ensuring the efficacy of formaldehyde-based sterilization processes. By using highly resistant bacterial spores, they provide a robust and reliable method for validating that the sterilization conditions are sufficient to achieve complete sterility, thus ensuring the safety and effectiveness of sterilized items.
●Process: Formaldehyde
●Microorganism: Geobacillus stearothermophilus(ATCCR@ 7953)
●Population: 10^6 Spores/carrier
●Read-Out Time: 20 min, 1 hr
●Regulations: ISO13485:2016/NS-EN ISO13485:2016
●ISO 11138-1:2017; Bl Premarket Notification[510(k)], Submissions, issued October 4, 2007
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Ethylene Oxide Sterilization Biological Indicator
Ethylene Oxide Sterilization Biological Indicators are essential tools for verifying the efficacy of EtO sterilization processes. By using highly resistant bacterial spores, they provide a robust and reliable method for ensuring that sterilization conditions are met, contributing to effective infection control and regulatory compliance.
●Process: Ethylene Oxide
●Microorganism: Bacillus atrophaeus(ATCCR@ 9372)
●Population: 10^6 Spores/carrier
●Read-Out Time: 3 hr, 24 Hr, 48 hr
●Regulations: ISO13485:2016/NS-EN ISO13485:2016ISO 11138-1:2017; ISO 11138-2:2017; ISO 11138-8:2021
