Tyski Stefan, Bocian Ewa, Grzybowska Wanda
Department of Antibiotics and Microbiology, National Medicines Institute, Warsaw, Poland.
Rocz Panstw Zakl Hig. 2013;64(2):111-5.
Evaluation of the biocidal activity of chemical disinfectants and antiseptics according to European Standards (EN) is based on determination of the reduction of the number of viable test microorganisms under defined conditions.
The objective of this study was to investigate whether reducing the neutralization time required following declared product contact times for the tested microorganisms yields method validations.
This study was conducted on 14 products containing active substances from different chemical groups: alcohols, aldehydes, biguanides, quaternary ammonium compounds, phenols, amines derivatives, oxidizing agents. These products were tested according to phase 1 tests: EN 1040:2005 and EN 1275:2005 and then according to phase 2, step 1 tests: Draft EN 13727:2005 and EN 13624:2003. Biocidal activity was evaluated using the following test organisms: S. aureus ATCC 6538, P. aeruginosa ATCC 15442, E. coli NCTC 10538, E. coli ATCC 10536, E. hirae ATCC 10541, C. albicans ATCC 10231 and A. brasiliensis ATCC 16404.
Validation C results for all products and tested microorganism strains were at least half of the density of the suspension for validation (Nvo) after only 10 s of neutralization. Furthermore, results from test procedures performed in parallel were also positive except 5 products toward A. brasiliensis.
The results of our study confirm that the contact time described in the European Standards phase 1: EN 1040 and EN 1275, as well as phase 2, step 1: Draft EN 13727 and EN 13624 can be precisely determined in spite of reducing the neutralization time from 5 minutes to even 10 seconds.
根据欧洲标准（EN）对化学消毒剂和防腐剂的杀菌活性进行评估，是基于在规定条件下测定受试微生物存活数量的减少情况。
本研究的目的是调查在宣称的产品与受试微生物接触时间后，减少所需的中和时间是否能使方法得到验证。
本研究针对14种含有不同化学基团活性物质的产品展开：醇类、醛类、双胍类、季铵化合物、酚类、胺类衍生物、氧化剂。这些产品先按照阶段1测试标准：EN 1040:2005和EN 1275:2005进行测试，然后按照阶段2第1步测试标准：EN 13727:2005草案和EN 13624:2003进行测试。使用以下受试生物评估杀菌活性：金黄色葡萄球菌ATCC 6538、铜绿假单胞菌ATCC 15442、大肠杆菌NCTC 10538、大肠杆菌ATCC 10536、迟缓爱德华氏菌ATCC 10541、白色念珠菌ATCC 10231和巴西曲霉ATCC 16404。
所有产品和受试微生物菌株的验证C结果在中和仅10秒后，至少是验证悬浮液密度（Nvo）的一半。此外，除了5种产品对巴西曲霉的测试外，并行进行的测试程序结果也均为阳性。
我们的研究结果证实，尽管将中和时间从5分钟减少至甚至10秒，但欧洲标准第1阶段（EN 1040和EN 1275）以及第2阶段第1步（EN 13727草案和EN 13624）中描述的接触时间仍可精确确定。
