微生物学EN测试

欧洲国家和其他司法管辖区要求杀菌剂产品, 受欧洲化学品管理局(ECHA)监管, 采用欧洲标准进行测试. Successfully navigate ECHA regulations and ensure compliance to in-depth testing requirements with the support of Element’s consultative regulatory and scientific experts.

ECHA规定的杀菌剂产品的详细测试要求见 生物杀灭剂规例 (BPR). Typically, 杀菌剂产品的测试分两步进行, 同时使用基于悬浮的方法和基于载体的方法. With more than fifteen years of experience supporting the successful registration of biocidal products in the European market, 除了我们丰富的经验, expertise, 以及监管知识, Element是领先杀菌剂产品开发商的首选合作伙伴, manufacturers, and marketers. Explore a partnership 今天与Element的抗菌专家一起.

浏览我们的方法后，如果您发现我们遗漏了您感兴趣的方法，请 reach out 让我们探索替代方法和自定义协议. 

悬架测试

EN 1040 -化学消毒剂的基本杀菌活性 -欧洲标准; EN 1040, specifies a test method and minimum requirements for basic bactericidal activity of a chemical disinfectant or antiseptic product. The test systems to be used in this study will follow the CEN (European Committee for Standardization) approved method as specified in EN 1040.

在测试物质中加入细菌悬浮液. 在赞助商指定的曝光时间, an aliquot is taken; the bactericidal and/or bacteriostatic activity in this portion is immediately suppressed by dilution neutralization or filtration neutralization. The number of surviving bacteria in each sample is determined and the reduction in viable counts is calculated. 适当的初始悬浮, culture purity, 进行无菌性和中和性验证控制.

EN 1275 - Quantitative Suspension Test for the Evaluation of Basic Fungicidal or Basic Yeasticidal Activity of Chemical Disinfectants -欧洲标准; EN 1275, specifies a test method and minimum requirements for basic fungicidal or basic yeasticidal activity of a chemical disinfectant or antiseptic product. The test systems to be used in this study will follow the CEN (European Committee for Standardization) approved method as specified in EN 1275. CEN公布的制备/加工曲霉的最新方法, 参照en1650, 在这个协议中使用.

将真菌悬浮液添加到制备好的测试物质样品中. 在赞助商指定的曝光时间, an aliquot is removed and the fungicidal and/or fungistatic activity in this portion is immediately suppressed by dilution neutralization or filtration neutralization. 确定每个样品中存活真菌的数量，并计算活菌数量的减少. 适当的培养纯度, sterility, 中和验证和初始悬浮进行.

EN 1276 - 评价化学消毒剂杀菌活性的定量悬浮试验 本方法适用于食品中使用的产品, industrial, domestic, and institutional areas excluding situations where disinfection is medically indicating and excluding products used on living tissues except those for hand hygiene. The test systems to be used in this study will follow the CEN (European Committee for Standardization) approved method as specified in EN 1276.

在试验物质和干扰物质中加入细菌悬浮液. 在赞助商指定的曝光时间, an aliquot is taken, 稀释中和或过滤中和可立即抑制抗菌作用. The number of surviving bacteria in each sample is determined and the reduction in viable counts is calculated. 适当的培养纯度, sterility, initial suspension, 并执行中和验证控制.

EN 1650 - 化学消毒剂杀真菌活性评价的定量悬浮试验 -欧洲标准; EN 1650, describes a suspension test method for establishing the fungicidal or yeasticidal activity of chemical disinfectants or antiseptic products. The test systems to be used in this study will follow the CEN (European Committee for Standardization) approved method.

将真菌的测试悬浮液添加到测试物质和干扰物质的制备样品中. 在赞助商指定的曝光时间, an aliquot is removed and the fungicidal and/or fungistatic activity is immediately suppressed by dilution neutralization or filtration neutralization. 确定每个样品中存活真菌的数量，并计算活菌数量的减少. 适当的培养纯度, sterility, initial suspension, 执行中和验证控制.

EN 13727 - 化学消毒剂和防腐剂 - 定量悬浮液试验评价医学领域的杀菌活性 - The EN 13727 standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that are used in instrument disinfection by immersion, 并通过擦拭消毒表面, spraying, 水浸或其他方式. The test systems to be used in this study will follow CEN (European Committee for Standardization) approved method, EN 13727.

将细菌的测试悬浮液添加到制备好的测试物质和干扰物质的样品中. 在赞助商指定的曝光时间, an aliquot is taken; the bactericidal and/or bacteriostatic activity in this portion is immediately suppressed by dilution neutralization or filtration neutralization. The number of surviving bacteria in each sample is determined and the reduction in viable counts is calculated. 适当的初始悬浮, culture purity, sterility, 并执行中和验证控制.

EN 13624 - 化学消毒剂和防腐剂 - 医学领域杀真菌或杀酵母活性评价的定量悬浮试验 - The EN 13624 standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products intended to disinfect instruments by immersion in the medical area. The test systems to be used in this study will follow CEN (European Committee for Standardization) approved method, EN 13624. CEN公布的制备/加工曲霉的最新方法, 参照en1650, 在这个协议中使用.

将真菌的测试悬浮液添加到测试物质和干扰物质的制备样品中. 在赞助商指定的曝光时间, an aliquot is removed and the fungicidal and/or fungistatic activity is immediately suppressed by dilution neutralization or filtration neutralization. 确定每个样品中存活真菌的数量，并计算活菌数量的减少. 适当的初始悬浮, sterility, culture purity, 并执行中和验证控制.

EN 14348 - 化学消毒剂和防腐剂 - Quantitative Suspension Test for the Evaluation of Mycobactericidal Activity of Chemical Disinfectants in the Medical Area - 包括仪器消毒剂 - The EN 14348 standard specifies a test method and the minimum requirements for Mycobactericidal (or tuberculocidal) activity of a chemical disinfectant product designed for use in medical areas. The test systems to be used in this study will follow the CEN (European Committee for Standardization) approved method, EN 14348.

A test suspension of Mycobacteria is added to a prepared sample of the test substance and interfering substance. 在赞助商指定的曝光时间, an aliquot is taken; the Mycobactericidal activity in this portion is immediately suppressed by neutralization. The number of surviving Mycobacteria in each sample is determined and the reduction in viability is calculated. 适当的初始悬浮, culture purity, 进行无菌性和中和性验证控制.

硬表面试验

EN 13697 - 欧洲杀菌活性评价定量表面试验 - The purpose of this study is to determine the bactericidal activity of a test substance on a non-porous surface according to the test method EN 13697 CEN(欧洲标准化委员会). The method described is intended to determine the activity of commercial formulations or active substances on bacteria under the conditions in which they are intended to be used.

This study will follow the EN 13697 method and includes modifications to the test system drying procedure designed to ensure consistent performance in the laboratory. In addition, a ±1 hour incubation window has been allowed for after test incubation to provide reasonable laboratory flexibility during incubation. A film of bacterial cells dried on the surface of a specified carrier is exposed to the test substance for a specified exposure time. After exposure, 携带者被转移到含有中和亚种培养基的容器中，检测幸存者. 适当的初始悬浮, water, sterility, culture purity, 并执行中和验证控制.

The Element advantage

Element一直是领先开发人员值得信赖的合作伙伴, manufacturers, 还有三十多年的杀菌剂营销经验. 抗菌测试的领导者, 我们的科学和监管咨询专家随时了解最新的市场趋势和监管指导, 包括在业务流程重组中详细说明的深入测试需求. Confidently and successfully navigate ECHA regulatory requirements and product registration with the support of Element.

我们可以用我们网站上没有列出的方法来测试产品. 如果你没有看到你感兴趣的方法， connect with us today 探索替代方法. 在微生物学和病毒学方面有几十年的经验, 我们的团队可以开发定制协议来满足您的特定需求. 有关Element的抗菌EN检测和BPR微生物检测的更多信息，请 contact us today.