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