Röchling has set up Europe’s biggest storage facility for semi-finished products with biocompatible plastics for medical technology in order to be immediately available for supplying to you. Our Medical Grade product line (MG) includes the materials:
- Polystone P MG (PP)
- SUSTAPEEK MG (PEEK)
- SUSTASON PPSU MG (PPSU)
- SUSTARIN C MG (POM)
With Medical Grade we offer a host of modifications and colours. If your requirements are even higher, we will jointly develop with you the perfect material for your application. The extent of the tests conducted on biocompatibility varies depending on the material concerned.
With Medical Grade (MG) materials, a product range is at your disposal that has been especially developed with medical technology in mind.
All resins are high-quality materials from reputable sources. The compliance of their chemical composition with the food safety and hygiene requirements laid down by the FDA is confirmed by the manufacturers for all materials.
Information on the suitability of the materials for sterilisation can be found on page 18. The sterilisation methods which may be applied, and the number of sterilisation cycles which may be undergone by a medical product which has been made from our materials, depends on the part design, processing parameters, sterilisation temperature and exposure to chemicals. The manufacturer is therefore required to establish and evaluate the appropriate sterilisation method for each medical product (and, where applicable, the permitted number of sterilisation cycles).
Röchling offers a full traceability for MG products, allowing them to be traced from the semi-finished product right back to the batch of raw materials. Our ISO 13485-compliant quality management system enables us to ensure that the relevant requirements are met, verified and documented.
The MG materials show a high resistance against many commercially available disinfectants and cleaning agents. The results of basic tests are provided by the raw material suppliers and can be used as initial selection criteria. It is essential to test the materials in the relevant working conditions (temperature/concentration/time).
There are test results for bio-compatibility according to ISO 10993-5 and USP Class VI available for the Medical Grade materials (MG addition in the trade name) from Röchling Industrial. The tests were conducted directly on the semi-finished product for all standard colours.
Within the scope of selecting the suitable ma- terial for a medical-technical application, not only the technical requirements have to be considered. Often it is necessary to ensure the material is compatible with the human organism. Conforming with the European Guideline for Medical Products MDD 93/42 EEC, this biological assessment of a product is invariably requisite, if there is direct contact of the material or product with the patient.
The extent of such tests depends mainly on the precise intended use of the medical product (in particular the nature and duration of the physical contact). The chief basic regulations for biological testing and assessment of materials are DIN EN ISO 10993 and testing as per United States Pharmacopeia Class VI (USP Class VI for short). Despite the fact that the clearly more comprehensive ISO 10993 was originally meant to supersede testing as per USP Class VI, USP testing is very frequently referred to today to assess plastics.
DIN EN ISO 10993
The scope of the biocompatibility tests as per ISO 10993 on the specific nature of the physical contact, as well as on the duration of contact.
USP Class VI
- intracutaneous reactivity
- acute systemic toxicity
- short-term implantation (duration: 7 days)
Safety & Service
Our materials meeting the respective require-ments – in conjunction with a high degree of application-specific expertise and experience – form the basis for the success of our customers from the medical technology sector.
Alongside standard materials, these are, in particular, the Medical Grade materials from Röchling Industrial. These materials have been tested for biocompatibility on the semi-finished product conforming to ISO 10993-5 standard and USP Class VI.
This service package is the ideal basis for the selection of suitable materials for medical products or for components of medical products. It is inten- ded to assist our customers with the process of obtaining approval for their end products. It should be borne in mind that semi-finished plastic products are only the precursor to the final medical or pharmaceutical products/components. Regarding processing and application parameters of which we are not aware, it is the responsibility of the medical product manufacturer to ensure the suitability of our materials in the end product with respect to their compliance with the applicable directives and laws.
As the strategic partner of our customers from the medical technology sector, we are well acquainted with the special requirements of this industry. Seen in this light, we offer today the manufacturers of medical technical instruments and equipment more than mere thermoplastic semi-finished products on the basis of various high-performance plastics.
Alongside our comprehensive knowledge of plastics, our customers profit from our long years of experience in the medical technical industry. We know the requirements of the pertinent regulations, such as the Medical Device Act (MPG), the European Guideline for Medical Products 93/42 EEC, and are glad to advise our customers when they look for the suitable materials for their applications.
And what happens if there is not yet a suitable product available? Then our staff in the development departments will work on the new, customised material and realize your ideas
Today, end products made of our materials are used in a host of medical articles, devices and instruments. Apart from the Medical Grade materials with proven biocompatibility, these are also standard materials not coming into direct contact with patients.
Alongside grips and handles for classical surgical instruments or probe adapters (trials) for orthopaedic technology, high-performance plastics are implemented particularly as components for devices of minimally invasive surgery. By way of example, ocular funnels, grip rings or distal end heads for endoscopes are made of high-performance plastics.
In addition to the instruments used, inter alia, for the prophylaxis of dental diseases, the materials from Röchling Industrial are also to be found in dental treatment and therapy units.
Large-sized equipment of imaging diagnostic methods, such as X-ray technology, computer or magnetic resonance imaging, is unthinkable today without plastic components. They provide their services both inconspicuously inside the equipment as well as in biocompatible components, coming into direct contact with the patients (e.g. as patient supports or biopsy units). Unlike metallic materials, many plastics are transparent to X-rays in these diagnostic methods, and thus do not distort test results.
In anaesthetic and respiratory units, pistons, valves, supports and adapters made of high-performance plastics safeguard patients’ medical care. Dialysis units and cardiovascular support systems are operated with the assistance of machined end products made of Röchling plastics.
Pharmacy & biotechnology
No matter whether in spectrometers for instrumental analytics or in chromatography systems for purification of proteins in pharmaceutical production – components, such as sample changers, fluid distributors or valve housings, machined from semi-finished plastic products from Röchling Industrial – have been well established in these fields of application for many years now.