These requirements are fulfilled as a result of continuous production monitoring by an extensive quality management system. This in turn is supplemented with a large number of voluntary measures and certifications, for the greatest possible reliability for our customers. The Weinheim production site and regular quality control produce quality on a consistently high level.
For us as a manufacturer of materials that are also used in medical products, certification under international standards is just as much a matter of course as adherence to the pertinent legislation, e.g. REACH – followed unquestioningly and without exception by every manufacturer in the EU.
nora® materials are certified regularly by renowned testing institutes:
- SG pollutant test mark issued by the test and research institute PFI in Pirmasens
- SG plus certification supplements the requirements for the SG seal with microbial and physical tests as well as permanent monitoring of the production facilities
- Skin compatibility “excellent” tested by Dermatest
Declaration of clearance
Under the MDR (Medical Device Regulation, EU Regulation 2017/745), basic materials used for the production of medical products must be provided, amongst others, with a declaration of clearance with respect to their toxicological properties.
✔ nora® products are free of constituents posing toxicological and carcinogenic risks as set down under EU Regulation 2017/745.
The closed-cell surface structure also minimises the risk of harm to health in the form of germ and bacterial colonies and facilitates complete hygienic cleaning and disinfection.
✔ proven disinfectability ✔ phtalate-free and latex-free ✔ batch tracking ✔ proven cytotoxicity under ISO 10993 and more… Please feel free to contact us!
Environment & Sustainability
Also with regard to the environment and sustainability, nora systems GmbH is one of the leading companies in its field. For its commitment to research & development, nora systems was recently awarded the “innovation through research” seal by the Stifterverband für die Deutsche Wissenschaft (donors’ association for the promotion of humanities and sciences in Germany).
As a manufacturer in Germany, we assume special responsibility for consistent quality, innovative product developments, practicable variety, and the highest possible reliability and safety. As the basis, ISO 9001:2015 certification safeguards the unvarying quality of our products.
Continuous inhouse quality control is supplemented with extensive external testing and certifications – for uncompromising quality assurance far beyond the statutory requirements.
Acknowledged throughout the sector, this pollutant test mark is awarded by approved test institutes following regular and thorough material analyses.
The catalogue of test criteria for materials that get into contact with the skin has gotten much bigger since 2015. Materials do have to meet many new requirements to receive the SG certificate.
Since 1998, numerous nora® products have been tested and certified in compliance with the latest version of the SG test criteria catalog.
The SG pollutant test mark is awarded by approved test institutes following thorough material analyses. This test mark confirms that, according to current knowledge, there are no risks to the health of dealers, processors, or patients.
It entitles the test institute to take samples at any time from ongoing production and does not constitute a once only test.
nora® products are never only tested, but certified. This includes yearly review proceedings.
A simple test report does not confirm compliance with the SG mark.
The SG plus mark supplements the requirements for the SG seal with microbial and physical tests as well as permanent monitoring of the production facilities.
- Your plus in terms of quality: Certified load bearing properties & stability based on the findings of dynamic, sustained loading tests.
- Your plus in terms of hygiene: Proven disinfectability of contaminated footbeds and inserts.
- Your plus in terms of safety: Not only the materials, also the production facilities and production processes in Weinheim are tested and certified at regular intervals.
Dynamic, sustained loading tests serve to analyse the load bearing properties of nora® materials. This involves applying a 60 kg load to the material about 100,000 times and then comparing its thickness before and after loading.
Pressure tests verified a wide range of deformation patterns depending on material properties, Shore A hardness, and function (bedding, permanently resilient, stabilising). These findings provide practitioners with invaluable data they can use for the optimal combination of different materials for specific applications.
All nora® products are characterised by excellent restoration capabilities.
The disinfectability of contaminated footbeds and insoles with a commercially available disinfectant has been verified regularly by the PFI laboratory conducting extensive microbiological tests with precisely defined quantities of bacteria and fungi.
Disinfection is successful only on materials with closed cellular structures. Unlike foams with open cellular structures, closed cell surfaces are impenetrable to wound secretions, bacteria, and fungi, which can then be removed with ease.
“Tested disinfectability” may be claimed only when germs are reduced by 100%.
Permanent safety means not only tests on a single nora® material, but also permanent monitoring of the production facilities and production process.
This involves testing and documenting each stage of ongoing production with regular spot checks. These process tests are applied, for example, to the selection of raw materials, incoming inspections, mixtures, production, final inspections, packaging, documented material traceability, etc.
The Weinheim production site and regular quality control produce quality on a consistently high level.
SG plus Certification verifies greatest possible safety as defined under the MPG law – no ifs, no ands, no buts.
A plus in terms of quality, hygiene, and safety – This means not only the absence of materials that cause allergic reactions or exhibit carcinogenic effects, but tested disinfectability with a commercially available disinfectant, outstanding quality with respect to static and dynamic sustained loading, and certified production.
Once every factor has been tested and passed, the SG plus mark is issued.
Since 1988, nora® materials have been regularly tested for skin compatibility, previously by Institute Fresenius and now by the renowned Institute Dermatest.
The dermatological tests are performed on human skin. Through the patch test the material is tested by applying small patches of the material to the skin and after 24, 48 and 72 hours the skin is dermatologically examined.
Dermatest describes this test as follows:
“The patch test shows any primary irritation or contact dermatitis (by provoking allergic skin reactions in sensitised volunteers). The test substances are applied most of the time occlusively to the skin, i.e. under closed conditions, in appropriate concentrations.”
The nora® range has been comprehensively dermatologically tested and certified and therefore holds the Dermatest seal ‘excellent’. This guarantees, that there are no irritations or incompatibility reactions caused by the material.