Everything at a glance
Are you accredited in accordance with EN 14683, EN 14126, or EN 13795?
What do I have to do in order to have my product tested by you?
Please send us your request including contact information in writing to firstname.lastname@example.org. You will then receive our non-binding quote for the desired tests.
After contracting the tests, you will send us your product including the order to our address in Bischofshofen, Austria.
We have a disinfectant that we would like to have tested. What does the test cost?
We require at least the following information in order to be able to create a corresponding quote:
- What type of disinfectant is it?
Hand disinfectant (hygienic or surgical), hand wash, surface disinfectant (with or without mechanical action), instrument disinfectant, etc.
- For what areas of application is your disinfectant intended? Human medicine sector, food industry, industry, household and public facilities, or veterinary medicine sector.
- If it is intended for the human medicine sector: Is your product supposed to be listed by the ÖGHMP (Austrian Society for Hygiene and Microbiology and Preventative Medicine) or the VAH (Association for Applied Hygiene)
- Which ranges of efficacy are to be tested?
Bactericidal, yeasticidal, fungicidal, sporicidal, mycobactericidal, tuberculocidal, and/or virucidal efficacy.
How long does a test take?
It depends on the type and scope of the test. The processing time starting from the placement of the order, receipt of the test product, receipt of all documents and payment (in the case of prepayment) to the time when you receive the test report will be stated in the quote.
How much product is required?
The required quantity depends on the contracted scope of testing. Therefore this question cannot be answered until the order has been placed.
What do I require for the certification of my disinfectant?
HygCen Austria does not offer any certifications. We can test your product and have an expert opinion issued for these tests.
We would like to have the efficacy of our product against COVID-19 tested.
We are only permitted to work with Rick Group 2 microorganisms in our laboratory. The SARS-CoV-2 virus belongs to a higher Risk Group.
Disinfectants are effective against SARS-CoV-2 if they have been proven to have limited virucidal efficacy.
For surfaces or textiles with antiviral properties we offer a test using bovine coronavirus (BCV) as an alternative.
I would like to sell a medical device in the EU and in the USA. What tests do I require for this?
In order to be able to sell the medical device in the EU you will require an inspection in accordance with EN ISO 17664.
In order to be able to sell the medical device in the USA you will require an inspection in accordance with the guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff".
What test soil is used for the reprocessability?
There are various options for the test soil. The test soil will be coordinated to the application for which your medical device is being used.
The most common test soils are those in accordance with ISO / TS 15883-5, EN ISO 17664, or the guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff".
What information is required to test the reprocessability of medical devices?
In order to carry out the reprocessing of your medical device we require a detailed reprocessing guide from you with detailed instructions on how the cleaning, disinfection, and sterilization of your product are to be carried out. For machine reprocessing we require specification of the desired routine (chemical/thermal/chemo-thermal disinfection).
We also require specification of the cleaning agents and disinfectants that are to be used for it. If possible, please also provide the desired cleaning agents and disinfectants to us.
We have a disinfectant dosing device. What tests must be carried out on the device in order for it to be added to the Robert Koch Institute's list?
According to the recommendations of the Robert Koch Institute, the disinfectant dosing device must be tested according to the Robert Koch Institute's "requirements for the design, properties, and operation of decentralized disinfectant dosing devices".
The dosing accuracy will be checked during this. The testing of the dosing accuracy over a period of one year is also required.
How many devices will be blocked at the same time for a validation of washer-disinfectors/sterilizers?
In order to progress with the validation as quickly as possible, we often use 2 or three washer-disinfectors at the same time. However, we always attempt to structure the tests so that operations can continue with as little disruption as possible. We only ever use sterilizers one at a time.
Does a technician need to be present for the validation?
No. However, we request a contact person who can be reached (this can also include by telephone) for technical questions.
What documents should be available for an initial validation?
All documents on the IQ and OQ (if they exist) as well as operating manuals, test certificates, and similar documents should be available.
Does the same customer load need to be used for the revalidation of sterilizers each year?
In the worst case scenario the load must be used in a comparable form each year, but it does not have to involve the same instruments. In the rest of the customer consulting it is beneficial to use different instruments/materials over the years in order to cover the widest possible spectrum.
How long after the validation will the inspection report arrive?
Depending on the order it can take several weeks until all of the reports on the validation are complete. However, we can send out a confirmation of validation on short notice.
What is meant by "inspection date" on the first page of the inspection report?
If all samples are analyzed by our testing laboratory then the validation will be evaluated as a whole. This occurs at the time of the inspection date.
When does a cytotoxicity test need to be carried out?
According to EN ISO 10993-1:2009, Annex A, Table A.1, cytotoxicity tests come into consideration for all categories of medical devices that have contact with the body for an evaluation of their biological safety on the basis of a risk analysis.
Cytotoxicity tests employing cell culture techniques shall be used to determine the lysis of cells (cell death), the inhibition of cell growth, colony formation, and other effects on cells caused by medical devices, materials, or their extracts.
How is the material applied to the cells?
An extract is first prepared from the test material in accordance with EN ISO 10993-12. In doing so, it is to be taken into account that the extraction conditions are standardized so that there is comparable preparation of the extracts. A culture medium with serum serves as the extraction medium.
How are the results of the cytotoxicity tests evaluated?
If the relative cell viability for the highest concentration of the extract prepared from the test material (100% extract) is ≥ 70% of the blank sample then the material shall be regarded as non-cytotoxic. A reduction of the viability of cells by more than 30% shall be deemed cytotoxic efficacy.