{"id":4639,"date":"2026-11-04T06:18:32","date_gmt":"2026-11-04T06:18:32","guid":{"rendered":"https:\/\/nano-test.de\/?p=4639"},"modified":"2026-11-04T06:26:59","modified_gmt":"2026-11-04T06:26:59","slug":"mikrobiologische-wirksamkeitstests","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/11\/04\/mikrobiologische-wirksamkeitstests\/","title":{"rendered":"Microbiological efficacy tests | Bactericidal, fungicidal, virucidal"},"content":{"rendered":"
\n

Microbiological efficacy tests for biocidal products: the scientific basis for marketing approval<\/span><\/h1>\n

Biozidprodukte umfassen eine breite Palette von Produkten \u2013 wie Desinfektionsmittel, Antiseptika, Konservierungsmittel, Pestizide und Sch\u00e4dlingsbek\u00e4mpfungsmittel \u2013, die zur Bek\u00e4mpfung von Mikroorganismen oder Schadorganismen bestimmt sind. Damit diese Produkte in Verkehr gebracht werden d\u00fcrfen, muss die behauptete Wirksamkeit wissenschaftlich nachgewiesen werden. Microbiological efficacy tests<\/strong> messen die abt\u00f6tende oder hemmende Wirkung eines Biozidprodukts auf Zielmikroorganismen unter standardisierten Bedingungen.<\/span><\/p>\n

An efficacy test for biocidal products is not only an official requirement, but also forms the basis for the reliability of the marketing statements on a product. Without efficacy data, it is not possible to obtain approval for a biocidal product. Therefore, the proper design of the tests, their implementation in accordance with the applicable standards and the comprehensive reporting directly determine the approval process of your product.<\/span><\/p>\n

The scientific basis of microbiological efficacy tests<\/span><\/h2>\n

Mikrobiologische Wirksamkeitstests basieren auf der quantitativen Messung der Wirkung eines Biozidprodukts auf Zielmikroorganismen bei einer bestimmten Konzentration, einer bestimmten Einwirkzeit und unter bestimmten Bedingungen. Das prim\u00e4re Ergebnis des Tests ist der logarithmische Reduktionswert (log-Reduktion)<\/strong>, der als Differenz zwischen der anf\u00e4nglichen Mikroorganismenzahl und der Zahl nach dem Test berechnet wird. Eine 5-log-Reduktion bedeutet beispielsweise, dass die anf\u00e4ngliche Mikroorganismenzahl um den Faktor 100\u2019000 abgenommen hat, und stellt einen h\u00e4ufig geforderten Schwellenwert f\u00fcr die Wirksamkeit von Desinfektionsmitteln dar.<\/span><\/p>\n

The test design depends on factors such as the target microorganism species, the scope of the product (body care, food contact surfaces, hospital environments, veterinary facilities), the exposure time, temperature and organic load. By adding an organic load (dirt, serum, proteins) to the test conditions, the performance of the product can be more accurately simulated under real conditions of use. For this reason, effectiveness tests are carried out according to different standards, depending on the product class and application scenario.<\/span><\/p>\n

Biocide efficacy tests are divided into three main groups depending on the product's range of effects: bactericides (bacterial killings), fungicides (fungal killers) and virucidal (virus-killing) efficacy. In addition, sporicides (spore-killing), mycobactericides (mycobacterial killers) and tuberculocidal efficacy tests may also be required, depending on the information on the product. Different reference strains of microorganisms and different standards are used for each type of efficacy.<\/span><\/p>\n

Efficacy Tests by Product Class<\/span><\/h3>\n

Biozidprodukte unterliegen je nach Verwendungszweck unterschiedlichen Anforderungen an die Wirksamkeitstests. Tests f\u00fcr Desinfektionsmittel<\/strong> werden je nach Anwendungsbereich (menschliche Gesundheit, Veterin\u00e4rmedizin, Lebensmittel, Haushalt) nach unterschiedlichen Normen durchgef\u00fchrt. F\u00fcr Desinfektionsmittel, die im Spitalbereich eingesetzt werden, sind eine bakterizide und fungizide Wirksamkeit unter Bedingungen mit hoher organischer Belastung erforderlich; f\u00fcr viruzide Angaben sind zus\u00e4tzliche viruzide Tests erforderlich. Pr\u00fcfungen f\u00fcr Antiseptika<\/strong> dienen der Bewertung ihrer Wirksamkeit auf der Haut und den Schleimh\u00e4uten. F\u00fcr Konservierungsmittel<\/strong> (die in Kosmetika, Arzneimitteln und Industrieprodukten verwendet werden) wird eine Pr\u00fcfung der Konservierungswirksamkeit \u2013 bekannt als Challenge-Test \u2013 durchgef\u00fchrt; diese Pr\u00fcfung bewertet, ob das Produkt w\u00e4hrend seiner gesamten Haltbarkeitsdauer Schutz vor mikrobieller Kontamination bietet.<\/span><\/p>\n

Pr\u00fcfungen f\u00fcr Handdesinfektionsmittel<\/strong> werden gem\u00e4ss spezifischen Normen wie EN 1500 (hygienische Handdesinfektion) und EN 12791 (chirurgische Handdesinfektion) durchgef\u00fchrt. F\u00fcr Fl\u00e4chendesinfektionsmittel<\/strong> kommen die Normen EN 1276 (bakterizid), EN 1650 (fungizid) und EN 14476 (viruzid) zur Anwendung. F\u00fcr Instrumentendesinfektionsmittel<\/strong> gelten die Normen EN 13727, EN 14561 und EN 14476. Jede Norm definiert unterschiedliche Anforderungen hinsichtlich Testmikroorganismen, Einwirkzeit, organischer Belastung und Akzeptanzkriterien.<\/span><\/p>\n

The following table summarizes the effectiveness test standards used according to the main classes of biocidal products.<\/span><\/p>\n\n\n\n\n\n\n\n\n\n
Microbiological Efficacy Test Standards by Biocidal Product Class<\/strong><\/span><\/caption>\n
Product class<\/span><\/th>\nBactericidal<\/span><\/th>\nFungicide<\/span><\/th>\nVirucidal<\/span><\/th>\n<\/tr>\n<\/thead>\n
Hand sanitizer<\/strong><\/span><\/td>\nEN 1500, EN 12791<\/span><\/td>\nEN 1500 (additional fungicide efficacy test)<\/span><\/td>\nEN 14476<\/span><\/td>\n<\/tr>\n
Surface disinfectant<\/strong><\/span><\/td>\nEN 1276, EN 13697<\/span><\/td>\nEN 1650, EN 13697<\/span><\/td>\nEN 14476, EN 16777<\/span><\/td>\n<\/tr>\n
Instrument disinfectant<\/strong><\/span><\/td>\nEN 13727, EN 14561<\/span><\/td>\nEN 13624, EN 14562<\/span><\/td>\nEN 14476<\/span><\/td>\n<\/tr>\n
Antiseptics<\/strong><\/span><\/td>\nEN 1040, EN 13727<\/span><\/td>\nEN 1275, EN 13624<\/span><\/td>\nEN 14476<\/span><\/td>\n<\/tr>\n
Preservative (Challenge Test)<\/strong><\/span><\/td>\nISO 11930, USP <51>, EP 5.1.3<\/span><\/td>\nISO 11930, USP <51>, EP 5.1.3<\/span><\/td>\n\u2014<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Test parameters<\/span><\/h3>\n

Test parameters include exposure time, temperature, organic load and product concentration. Each of these parameters must be kept within the ranges specified in the standard; Otherwise, the results are considered invalid. In order to ensure the reproducibility of the test, all steps must also be carried out according to the standard work instructions (SOPs) and properly documented. Our laboratory reports on all tests according to the GLP principles, traceable and with complete quality control data.<\/span><\/p>\n

BPR and the regulatory framework<\/span><\/h3>\n

In der Europ\u00e4ischen Union werden Biozidprodukte gem\u00e4ss der BPR (Biozid-Verordnung \u2013 528\/2012)<\/strong> zugelassen. Die BPR schreibt vor, dass Wirksamkeitstests durchgef\u00fchrt werden m\u00fcssen, die f\u00fcr das angegebene Wirkungsspektrum des Produkts geeignet sind, um dessen Wirksamkeit nachzuweisen. Wirksamkeitsdaten sind ein wesentlicher Bestandteil des Zulassungsgesuchs f\u00fcr das Produkt, und ohne diese Daten wird das Gesuch nicht entgegengenommen.<\/span><\/p>\n

According to the BPR, effectiveness tests are assessed by the competent authority of the Member State in question on the basis of the intended use of the product. The tests must be performed in an accredited laboratory under GLP or GMP conditions, and the results must be fully documented. In addition, the specified spectrum of activity of the product must correspond to the application instructions given on the label; Inconsistencies between the efficacy data and the information on the etiquette can lead to serious problems during the admissions process.<\/span><\/p>\n

Scope of our laboratory<\/span><\/h2>\n

Unser GLP-zertifiziertes Labor f\u00fchrt bakterizide, fungizide und viruzide Wirksamkeitstests<\/a> f\u00fcr Biozidprodukte gem\u00e4ss den einschl\u00e4gigen EN-Normen und den Anforderungen der BPR durch.<\/span>
\nOur test method begins with an assessment of the product properties and the specified spectrum of effects; Subsequently, the appropriate standard, the test microorganisms and the test conditions are determined. The tests are carried out using validated methods and accompanied by quality control data.<\/span><\/p>\n

Testing the biocidal efficacy is a crucial part of the approval process for your product.<\/span>
\nThe right standards, appropriate test design and comprehensive reporting prevent delays in the approval process and guarantee the reliability of your product information. Our laboratory provides the scientific infrastructure and regulatory expertise you need throughout this process.<\/span><\/p>\n

Frequently Asked Questions<\/span><\/h2>\n

Welche Wirksamkeitstests sind f\u00fcr mein Produkt erforderlich?<\/strong> Die erforderlichen Tests h\u00e4ngen vom Verwendungszweck des Produkts und dem angegebenen Wirkungsspektrum ab. Bei Desinfektionsmitteln sind je nach Verwendungszweck bakterizide, fungizide und viruzide Tests erforderlich; bei Konservierungsmitteln ist ein Challenge-Test erforderlich; und bei Antiseptika sind Wirksamkeitstests an Haut und Schleimh\u00e4uten erforderlich. Unser Labor ermittelt die erforderliche Testliste auf der Grundlage der Eigenschaften Ihres Produkts.<\/span><\/p>\n

Wie lange dauern die Tests?<\/strong> Die Testdauer variiert je nach Art der Wirksamkeit und der Norm. Bakterizide und fungizide Tests dauern in der Regel 2\u20134 Wochen; viruzide Tests k\u00f6nnen aufgrund der Zellkulturphasen 4\u20136 Wochen dauern.<\/span>
\nIncluding reporting and quality assurance, the total duration is 4-8 weeks.<\/span><\/p>\n

Kann ein Zulassungsgesuch ohne Wirksamkeitsdaten eingereicht werden?<\/strong> Nein. Gem\u00e4ss der BPR und der t\u00fcrkischen Biozidverordnung sind Wirksamkeitsdaten ein obligatorischer Bestandteil des Zulassungsgesuchs. Antr\u00e4ge ohne Wirksamkeitsdaten werden nicht akzeptiert.<\/span><\/p>\n

Contact our laboratory to scientifically demonstrate the effectiveness of your biocidal product and speed up your approval process. Our team of experts develops a test strategy tailored to your product and will provide you with all the necessary effectiveness data in full.<\/em><\/span><\/p>\n<\/article>\n","protected":false},"excerpt":{"rendered":"

Mikrobiologische Wirksamkeitstests f\u00fcr Biozidprodukte: Die wissenschaftliche Grundlage f\u00fcr die Marktzulassung Biozidprodukte umfassen eine breite Palette von Produkten \u2013 wie Desinfektionsmittel, Antiseptika, Konservierungsmittel, Pestizide und Sch\u00e4dlingsbek\u00e4mpfungsmittel \u2013, die zur Bek\u00e4mpfung von Mikroorganismen oder Schadorganismen bestimmt sind. Damit diese Produkte in Verkehr gebracht werden d\u00fcrfen, muss die behauptete Wirksamkeit wissenschaftlich nachgewiesen werden. Mikrobiologische Wirksamkeitstests messen die abt\u00f6tende \u2026 Mikrobiologische Wirksamkeitstests | Bakterizid, fungizid, viruzid\u201c>Continue reading Microbiological efficacy tests | Bactericidal, fungicidal, virucidal<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4640,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-4639","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biozid-blog"],"yoast_head":"\nMikrobiologische Wirksamkeitstests | Bakterizid, fungizid, viruzid | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Wir f\u00fchren Wirksamkeitstests zur bakteriziden, fungiziden und viruziden Wirkung von Biozidprodukten gem\u00e4\u00df den einschl\u00e4gigen Normen und unter Einhaltung der GLP-Standards durch.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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