In vitro test for sensitisation by activation of epidermal keratinocytes according to DIN EN ISO 10993-10, Annex C
The skin sensitisation is evaluated by measuring the basal release of IL-18 after application of a product extract to the air-liquid interface of the reconstructed human epidermis (RhE) (test can be combined with the test for skin irritation according to DIN EN ISO 10993-23)

In vitro test for sensitisation by activation of epidermal dendritic cells according to DIN EN ISO 10993-10, Annex C
In the U-SENS test, the changes in the expression of the cell surface marker CD86 on U937 cells are quantitatively determined using flow cytometry. The reaction of the human immune cells to the sample extract allows the assessment of an allergenic hazard potential of the examined sample.

Biocompatibility evaluation of breathing gas pathways in healthcare applications
o DIN EN ISO 18562-1 Evaluation and testing within a risk management process
o DIN EN ISO 18562-2 Tests for emissions of particulate matter
o DIN EN ISO 18562-3 Tests for emissions of volatile organic compounds (VOCs)
o DIN EN ISO 18562-4 Tests for leachables in condensates

Further tests on request
Please also contact us on the subject of biocompatible coatings for medical devices. With our innovative test set-ups, we collect valuable preclinical data on this topic.

We offer normative tests to validate product claims for surface disinfection, instrument disinfection and textile disinfection:

We test and evaluate medical compression textiles for you:

Particularly high demands are placed on surgical textiles. The transmission of infectious agents between hospital staff and patients during surgical and other invasive procedures should be minimised as far as possible. By fulfilling basic requirements, the textiles contribute to the general safety of patients.

Hohenstein tests your products for compliance with the performance requirements of single-use and reusable surgical drapes and gowns for use as medical devices according to the specifications of the European standard 13795-1:2019 or clean-air garments according to DIN EN 13795-2.

Biological tests

Physical tests

* Deviating from the requirement standard DIN EN 13795-1, the burst strength is not carried out according to EN ISO 13938-1, but according to EN ISO 13938-2. EN ISO 13938-1 section 1 indicates that there is no significant difference in the bursting strength results achieved using tests according to EN ISO 13938-1 (hydraulic method) and EN ISO 13938-2 (pneumatic method) for pressures up to 800 kPa.

The primary use of medical face masks is to keep infectious agents away from the patient and, in some circumstances, to additionally protect the wearer from splashes of potentially contaminated fluids. Medical face masks may also be intended to be worn by patients and others to reduce the risk of spreading infections, especially in epidemic or pandemic situations.

Efficiency / function of medical face masks according to DIN EN 14683

According to the European requirements standard EN 14683, medical face masks are classified into two types (Type I and Type II) based on bacterial filtration performance, with Type II being further subdivided according to whether or not the mask is liquid resistant. The "R" stands for splash resistance.

Tests for Type I / Type II:

Additional test for type IIR:

Our offer

For medical devices, a shelf life must be specified after which the functionality and safety of the product can still be guaranteed. For this purpose, the product's requirement parameters are checked on aged samples or samples stored for the shelf life.

Since no experience or test values for batches stored in real time are yet available for new or modified products, accelerated aging is used to simulate real time aging for the shelf life of the medical devices. In an accelerated aging test for medical devices per ASTM F1980 (Standard Guide for Accelerated Aging of Packaging for Sterile Medical Devices), packages are stored at an elevated temperature. For example, a storage period of 2 years can be reduced to a few weeks.

We offer

Example medical face masks

Hohenstein offers testing of product requirements for medical masks in new condition as well as after accelerated ageing and real-time storage. For accelerated ageing, the masks are stored at 55 °C in a constant climate chamber, which shortens testing of aged masks - depending on the manufacturer's information on storage temperature and shelf life - to approx. 8 - 12 weeks.

Regular sampling of test samples, screening tests on the requirement parameters and photo documentation allow the influence of storage/ageing of the material on product safety and life to be estimated during the course and at the end of simulated ageing. This serves to collect rapid experimental data on the product's durability and supports quality assurance until real-time durability data is available (e.g. after 2 years of storage).

Some examples from our portfolio

Is your product or your question not listed here? Simply contact us. We are also happy to develop individual test set-ups for testing your product.

*DIN SPEC 13257

The new DIN SPEC 13257 specifies requirements for foot dressings in medical foot treatment for single use and defines corresponding test procedures for their compliance in a 16-page paper. The DIN SPEC was developed in workshops according to the so-called PAS method by the company Pedilay Care GmbH. To achieve this, the young company brought Hohenstein on board as textile experts. The product standard is used in both the medical and nursing context of the health care system.

Additional health-related offers

In addition to the assessment of medical devices in accordance with the requirements of the Medical Devices Regulation, we also offer other health-related services. These include, for example, tests for harmful substances in textiles and leather articles, proof of the UV protection effect of clothing and shading textiles as well as tests for compliance with hygienic requirements for textiles and surfaces.

Applied hygiene

Whether it is general occupational hygiene, hygiene management, drinking water analyses or the investigation of the antimicrobial effectiveness - hygiene inspections by Hohenstein are a matter of cleanliness. In addition, we also officially monitor the hygiene in laundry operations of the German Certification Association for Professional Textile Services.

Textile UV protection

Hohenstein tests garments and shading textiles for their UV protection factor, based on international standards such as UV STANDARD 801, the Australian-New Zealand Standard (AS/NZS 4399), the European Standard (DIN EN 13758-1) or the American Standard (AATCC TM 183).

Testing for harmful substances

Hohenstein tests textiles and leather products for harmful substances to ensure legal compliance and observance of international standards such as STANDARD 100 by OEKO-TEX® or other, customer-specific restricted substances lists (RSL).