When is the public NIOS test

EN 14885

Hygiene and effectiveness tests

Hygiene matters in the fields of human and veterinary medicine a special role. But also in the food industry and in special situations in the household or public institutions it applies, to work with low germs. Because germs sometimes cause serious diseases and infections.

Chemical disinfectants prevent the transmission of disease from surfaces, instruments or other carrier materials. Antiseptics reduce germs on body surfaces, wounds and tissue - in humans and animals. Different disinfectants or antiseptics are suitable for each area of ​​application.

In order to user be able to choose the right product, have to you to the information on Effectiveness. Simultaneously endanger many ingredients Humans, animals and the environment.

Therefore strict and highly complex requirements apply. Some chemical disinfectants are among them Biocidal products, other than Medical devices. Surface and hand disinfectants, for example, meet both criteria. But regardless of the product, the area of ​​application and the country - all regulations require effectiveness tests according to certain specifications. These Tests are supposed to certify, that the This is how disinfectants and antiseptics work, as specified by the manufacturer. At the same time, they protect users and patients from possible damage to health. As a manufacturer, reduce this risk and commission HygCen to test your effectiveness.

Effective disinfection

Disinfections are designed to interrupt the transmission of diseases. To do this, the disinfectant used must irrevocably reduce the presence of pathogens. In principle there is chemical, chemothermal and physical Disinfection methods. The so-called “reduction factor” defines the value that describes the extent of the disinfection effect. If a certain “germ reduction limit” is reached in the laboratory test, a product is considered to be effective. Laboratories give it as a decadic logarithm (lg). It describes how much a disinfectant reduces the number of test organisms. Depending on the test method, the lg is between ≥ lg 2 and ≥ lg 5, i.e. over 102 and 105 Stages. The result of the disinfection is therefore always dependent on the initial pollution (bioburden) of the surface.

Biocides

Biocides are literally substances that destroy life (“bios” = Greek “life”, “caedere” = Latin “kill”). The active ingredients and preparations are used to destroy, destroy or deter harmful organisms. They remove microorganisms or pests (such as woodworms, mice, etc.) chemically or biologically.

Approval procedure for biocides

Biocides are supposed to be food, building materials (e.g. wood) and other everyday items protect and sufficient buildingEnsure hygiene. At the same time, their inherent properties endanger humans, Animal and environment (European Regulation (EU) No. 528/2012). The current Biocide regulation facilitated the free movement of biocidal products in the EU. Parallel elevated the regulation den Protection of the biosphere. The Biocide Ordinance refers to this Precautionary principle. Possible dangers must therefore be excluded before marketing. All biocidal products are therefore subject to authorization. The admission process is a two step process. First, the biocidal active ingredients are tested using European procedures. The authority leaves the checked Biocidal active ingredient too, he will in the Positive list added. The biocide as a whole can only be tested and approved if all biocidal active ingredients of a biocidal product are on this “Union list”. Disinfectants represent one of four main groups in the Biocide Ordinance.

The HygCen test laboratory tests your biocidal products and individual biocidal active ingredients. Nothing stands in the way of your disinfectant being approved for the market.

HygCen checks your chemical disinfectants and antiseptics

  • On microbiocidal effectiveness

    HygCen tests whether your product is effective against vegetative bacteria, bacterial and fungal spores, yeasts and viruses.
  • According to all standards of EN 14885
    The overview standard specifies which European standards your product must meet in order to be considered microbicidal. If your product passes all the tests, it can be approved for the market.
  • For specific requirements

    Country-specific lists require individual test procedures that deviate from EN 14885. HygCen checks your product, e.g. according to the requirements of the RKI listing, VAH listing and much more. Contact us!

Advantages of our effectiveness test

  • Independent tests for market approval
    Manufacturers must prove independent tests and assessments of the effectiveness of their product. HygCen is an accredited and recognized test laboratory for these tests.
  • Protection of patients, users, animals and the environment
    Biocides and their active ingredients not only endanger pests and germs. With their inherent properties, they threaten all living things. Before marketing them, it is important to rule out all risks.
  • Testing of the finest recipe variants
    Even small variations in the ingredients can greatly change the effectiveness of your disinfectant. HygCen compares and checks the slightest changes in your product.

Overview standard EN 14885 - Chemical disinfectants and antiseptics

The Standard EN 14885 enables manufacturers, Users and responsible supervisory authorities, the Assess effectiveness of chemical disinfectants and antiseptics. The EU standard EN 14885 represents a Overview standard This is required by the highly complex regulation such disinfecting agents. In EN 14885 numerous standards are enshrined that Define test procedures and approval requirements for these products. The European standard provides a good overview of the use of chemical disinfectants and antiseptics in all essential areas. This applies to products of the Human and veterinary medicine just like which of the Food and other industries. In addition, EN 14885 regulates Tests of disinfectants for household or public facilities.

When will your disinfectant or antiseptic be marketed in the EU?

Without an independent examination, you will not receive any marketing authorization in Europe. The European authorities request therefore, that an independent testing institute confirms the effectiveness and the safe use of your product. Regardless of whether your product should have bactericidal, yeasticidal, fungicidal, mycobactericidal, tuberculocidal or virucidal effectiveness: The effect must be proven by two specific tests. On the one hand through the quantitative suspension test of phase 2, step 1. On the other hand through the quantitative carrier test of phase 2, stage 2.

National peculiarities
Numerous national specifications and regulations supplement the European specifications. Nationwide, for example, many medical facilities only use preparations with a VAH certificate for preventive disinfection. The V.erbund for A.applied Hygiene is a non-profit association that pays particular attention to standards-compliant tests. For the VAH listing, a manufacturer must, among other things, two test reports including two reports from two independent experts, accredited testing institutes show. After a successful recording, the remains VAH listing is valid for three years. Afterwards a Recertification process so that the product remains listed. All listing-relevant tests and reports have in common that, in addition to the European requirements, to meet further requirements applies.

The DVG (German Veterinary Medical Society) has three lists for users:

  • DVG list for the animal husbandry sector
  • DVG list for the food sector
  • DVG list for veterinary practices and animal shelters

All products listed in the DVG list for animal husbandry are tested in accordance with the EN test standards that are binding for the respective area of ​​application. The DVG guidelines specific to these areas only apply to those areas for which phase 2 / step 2 EN test standards on porous germ carriers have not yet been established (e.g. for effectiveness against viruses and parasites).

DVG-specific quality assurance criteria:

  • Company-independent testing of effectiveness
  • Repeatability of the results through at least two effectiveness tests in two independent test laboratories
  • Detailed examination of the submitted test reports by committee members
  • The listing entries are created by the DVG disinfection committee (and not by the companies themselves).

As an accredited testing laboratory, HygCen tests your chemical disinfectants and antiseptics in accordance with all known national and international specifications and standards. The EN 14885 regulates the tests and requirements for all relevant areas of application.

HygCen tests your products for all areas of application from EN 14885

Human medicine

We test preparations that are used in hospitals, municipal medical facilities or in the dental field.

  1. Hygienic hand disinfection and washing
  2. Surgical hand disinfection or washing
  3. Surface disinfection (with / without mechanical effect)
  4. Instrument disinfection
  5. Textile disinfection
  6. Water treatment to control Legionella

 

Veterinary medicine

We examine active ingredients that are used in animal transport, production or removal of animals.

  1. General surface disinfection (with / without mechanical effect)
  2. Teat disinfection
  3. Disinfection of devices by immersion
  4. Hygienic hand washing and disinfection
  5. Surgical hand washing and disinfection

 

Food, industry, household & public institutions

We test chemical disinfectants and antiseptics for use in tourism and retail, the processing industry, in offices and households as well as public facilities (nursery ...).

  1. Surface disinfection with low / high loads
  2. Products for "cleaning in place" (CIP cleaning)
  3. Hygienic hand washing and disinfection
  4. Wipes
  5. Products for use in breweries, the beverage industry and non-alcoholic beverages
  6. Products for use in dairies
  7. Products used in the manufacture of cosmetics
  8. Products used in manufacturing in the pharmaceutical industry

Overview of the standards from EN 14885

The European overview standard applies to products that are supposed to be effective against the following microorganisms: vegetative bacteria (including Legionella and mycobacteria), yeasts, bacterial and fungal spores and viruses (including bacteriophages). In addition, EN 14885 also applies to active ingredients and disinfectants that are currently being developed or are not yet intended for a specific area of ​​application. For each area of ​​application, the tests must demonstrate different levels of reduction in the test organisms. Which standards according to EN 14885 could be relevant for your disinfectant or antiseptic, you can find out in our test.

This is how we check your chemical disinfectants and antiseptics

  1. Request an offer from us - by phone or online request. It is important for us to know: which product would you like to have tested, which ingredients does it contain and for which area of ​​application should it be used?
  2. You send us your chemical disinfectants or antisepticsas soon as you have accepted our offer.
  3. As soon as we have received your product, we initiate the commissioned assessment of your product according to the prescribed tests. We check in the original condition - i.e. how your product will be delivered and used in the future.
  4. We test according to all anchored norms in the European norm EN 14885 as well as other standards (RKI, VAH etc.). These tests are, in particular, quantitative suspension tests (Phase 2, step 1) and quantitative laboratory tests (Phase 2, step 2).
  5. You will receive a test report including an assessment from us. Our scientific director classifies the results of the test report for you in this assessment.

Overview of the tests of phase 1, phase 2 / step 1, phase 2 / step 2 and phase 3

Phase 2, step 1 - quantitative suspension tests

These tests are designed to confirm that a product has a bactericidal, fungicidal, yeasticidal, mycobactericidal, tuberculocidal, sporicidal or virucidal effects having. And under simulated practical conditions (especially loads) that apply to its intended use. We test the effectiveness of a disinfectant in quantitative suspension test generally as follows:

First we put one Base load that simulates normal soiling of a surface. We bring this together with one Starting germ suspension (at a defined height e.g. 108 CFU / ml) with Your disinfectant in contact. Then we wait for them specified exposure time from. Subsequently to stop we immediately check the further effects of your active ingredient chemically with a neutralizing agent from. Now we bring the mixture in different strengths diluted on agar plates and it follows the Incubation of the plates. After germ-specific time for the growth (e.g. 48h) we read the colony-forming units (KBE). Subsequently analyze we the Reduction of the initial germ quantity. For a product to be classified as bactericidal, the decadic logarithm must be ≥ lg 5, i.e. over 105 lie. If your disinfectant does not reach this value, a higher concentration of the active ingredient or a longer exposure time may achieve the desired effect.

Phase 2, Level 2 - quantitative laboratory tests

The tests are intended to certify that a product has a bactericidal, fungicidal, yeasticides, mycobactericidal, tuberculocide, sporicidal or virucidal effect having. In contrast to phase 2, stage 1, the product onto a surface or skin under simulated practical conditions applied (e.g. surface, instrument, hand washing and hand disinfection attempts).

Adapted optimal scope of testing

In the course of regulating disinfectants and antiseptics, there are numerous other specifications and norms in addition to the norms already mentioned. HygCen checks your chemical disinfectants and antiseptics according to the specifications, that you want. For the most part it is cheaper, to test different specifications at the same time staggered. Determine with HygCen Their optimal scope of testing. In this way, you can avoid costly additional tests.

REACH

The abbreviation of European chemicals regulation is derived from the English title “Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals”. Your German title is the European Chemicals Regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals. " Regulation (EC) No. 1907/2006 prescribesthat Chemicals should basically be produced and used in such a way that the negative consequences for humans, animals and the environment are as low as possible. To date, there is insufficient data for most of the chemicals used. Since 2007, the REACH guideline aims to change this fact. At the same time, the introduction of REACH has standardized chemicals law across Europe. As a manufacturer, you must ensure that your chemical disinfectants meet the requirements of REACH. We would be happy to test your active ingredients according to REACH requirements.

ECHA

ECHA is the European chemicals authority. She advocates the safe use of chemicals. The agency supports companies in complying with applicable laws. Chemicals of concern are carefully checked. ECHA's work focuses on the protection of people, animals and the environment. At the same time, the regulatory authority promotes the innovative ability and profitability of companies in the chemical industry. ECHA sets the guideline values ​​that chemical disinfectants must meet under certain conditions in order to be considered effective. If you have any further questions about ECHA, please do not hesitate to contact us!

CLP

CLP is the Regulation (EC) No. 1272/2008 about the Classification, labeling and packaging of substances and mixtures.

aim of the CLP regulation (Regulation on Classification, Labeling and Packaging of Substances and Mixtures) it is a to ensure a high level of protection for human health and the environment. In addition, the regulation is intended to free movement of goods within the common European internal traffic of chemical substances, mixtures and certain specific products. The CLP regulation is based on the so-called “Globally Harmonized System (GHS) of Classification and Labeling of Chemicals” of the United Nations (UN). The globally harmonized system aims to increase the level of the Make the protection of human health and the environment more uniform, transparent and comparable. Our experts at HygCen know which requirements your product must comply with according to the CLP regulation. Please contact us!

RKI list

Whenever officially ordered disinfection measures be carried out, comes the RKI list to wear. The disinfectant list of the Robert Koch Institute ensures that the registered Active ingredients and mixtures are effective. This is intended to protect people from communicable diseases. Registered products will be released at the same time Federal Environment Agency (UBA) as harmless to health and the environment classified. In order for the RKI to classify a product as effective, the disinfectant must be assessed by expert reports according to specified methods and / or in-house tests. The Assessment for the environmental impact takes place on the basis of the Application concentration and the valued Amount of disinfectant used.