抗菌器械的微生物学检测

The regulation of antimicrobial pesticide devices is complex, as the EPA or FDA regulate these devices depending on their intended use. 不管执政权威是什么, device producers are required to produce efficacy data to support all claims. Successfully navigate the complex regulations for these devices with im体育APP’s consultative regulatory and scientific experts.

Pesticide or antimicrobial devices produce an antimicrobial product or act as the antimicrobial themselves. UV, 消毒, 蒸汽, 臭氧, 红外, and ionizing devices are all antimicrobial pesticide devices. It is important to note antimicrobial pesticide devices that work by physical means are regulated by the US 环境 Protection Agency (EPA) but do not require registration. We have decades of experience testing to established methods and developing custom protocols. If the method you are interested in is not detailed here, 开始对话 看看我们怎样才能满足你们的需求.

紫外线装置测试

Evaluation of the 抗菌 Activity of a UV Device for Use on Inanimate 环境 Surfaces - The EPA requires that antimicrobial claims for 紫外线设备 be supported by appropriate scientific data demonstrating the efficacy of the device against the claimed organism. This is accomplished in the laboratory by treating the target organism with the test device under conditions which simulate as closely as possible, the actual conditions under which the test device is designed to be used. 用于硬材料上的产品, 无生命的, 无孔的表面, a carrier method is used in the generation of the supporting data.

A film of organism cells dried on a surface of glass carriers is exposed to the test device for a specified exposure time. Following exposure, the carriers are neutralized and assayed for survivors.
This study is designed to determine the antimicrobial activity of a UV device against specified test organisms. 结果以百分比和对数表示₁₀ 减少试验生物体. Minimum percent and log reduction values do not exist to specify a “passing” or “failing” test device.

灭菌装置检测

灭菌装置的功效 - The US 食物 and Drug Administration (FDA) requires that a Premarket Notification [510(k)] submission for 消毒 devices be supported by appropriate scientific data demonstrating the efficacy of the device against bacterial spore-forming organisms. This is accomplished in the laboratory by treating the target test organism with the 消毒 device under conditions which simulate as closely as possible the actual conditions under which the 消毒 device is designed to be used.

用于坚硬表面(干燥)的产品, 无生命的环境表面), a carrier method is used in the generation of the supporting data. The experimental design in this protocol meets these requirements. The test system to be used in this study will follow a modification to AOAC approved method for the determination of the Sporicidal Activity of Disinfectants. Because of its reliability in producing adequate spore titers, Method II has been employed in this protocol to generate 枯草芽孢杆菌 孢子.

A film of bacterial 孢子 dried on specified carriers is exposed to the test device for a specified exposure time. 曝光后, the carriers are transferred to vessels containing neutralizing subculture medium and assayed for survivors. The FDA efficacy performance requirements regarding 510(k) submission for sterilizers used in health care facilities requires killing microorganisms on all inoculated carriers.

定制抗微生物农药设备测试

Custom protocols can be developed to meet your specific 设备测试 需要. Our extensive experience working with a variety of devices includes, 但不限于, 以下几点:

• 紫外线设备
• 蒸汽清洗/拖地装置
• 臭氧设备
• 红外光装置
• 离子发生器
• 消毒液产生装置

im体育APP优势

Having served as a leader in antimicrobial testing for more than 30 years, im体育APP remains the trusted partner for leading developers, 制造商, 抗菌农药设备的营销人员. Confidently and successfully navigate and understand regulations for antimicrobial pesticide devices and generate needed data according to microbiology antimicrobial 设备测试 standards with the support of our consultative scientific and regulatory experts. If there is a method you do not see that you're interested in, please reach out. 我们很乐意谈谈.

For more information about im体育APP’s microbiological antimicrobial pesticide 设备测试, im体育APP 今天.