Notified bodies
Notified bodies are governmental accredited offices, which inspect (audit) – on the authority of a manufacturer – realised conformity evaluations of production processes and attest (certify) their correctness according to consistent evaluation standards.
CE label
The CE label is the mark to attest a medical device to have achieved essential requirements. According to the European Act on Medical Devices, medical devices may only be put in circulation if furnished with the CE label. The label must be applied on the device and/or its packing. It is not a legal, but a factual certification mark for safety and technical capability of the medical device.
Fluoropolymer
Fluoropolymers are materials whose essential part ist the chemical element fluor. Examples of fluoropolymers are polytetrafluoroethylene (PTFE), perfluoroalkoxy polymer resin (PFA), polyvinylidene fluoride (PVDF) and fluorinated ethylene-propylene (FEP). Many of these materials are also known as Teflon®. The characteristical attributes of fluoropolymers are their high chemical and thermical consistency. In addition, they have a low friction coefficient. Fluoropolymers can be injection moulded (PFA, PVDF, FEP) or sintered (PTFE).
Moldflow studies
Moldflow is an injection moulding simulation software. By means of computer simulation is analysed how liquid plastic flows into the injection moulding tool. That way, the injection moulded parts can be optimized (thickness, materials, cycle time etc.). This gains valuable time and therefore allows quicker introduction of the finished product to the market.
More detailed information at www.moldflow.com
PEEK
Polyetheretherketone (PEEK) belongs to Polyetherketones (PEK), which on their part belong to high temperature resistant, thermoplastic polymers. Within this group, PEEK is the most important and best known polymer. Its melting temperature is 335 °C. Polyetherketones are resistant against most organic and anorganic chemicals. Up to approximately 280 °C they are also resistant against hydrolysis. In contrast, they are not resistant against UV radiation, concentrated nitric acid, acidic and oxidising conditions in general and some halogenated hydrocarbons. PEEK resists every common sterilisation method. Some sorts of PEEK can even be sterilised up to a thousand times without showing significant losses of mechanical or chemical characteristics. Therefore, PEEK is often used in medical technology.
(Source: Wikipedia)
PFA
Perfluoroalkoxy polymer resin (PFA) is a highly fluoric polymer. Therefore, its chemical resistance is even higher than with PEEK and PVDF. However, PFA has a low consistency and density. It shows a very high temperature stability (melting point approximately 310 °C) and is flame-retardant (UL 94 V-0). PFA comes with a low friction coefficient, has a largely inert behaviour, a high sliding abrasion and extremely low adhesion.
Due to its outstanding characteristics, PFA is often used together with highly aggressive media or at high working temperatures.
(Source: Wikipedia)
PVDF
Polyvinylidene fluoride (PVDF) belongs to fluoropolymers. It is a transparent, partially crystalline, thermoplastic polymer. PVDF has a high consistency against many chemical substances. It is therefore ideal in contact with aggressive media such as hydrochloric acid. Due to its high maximal service temperature of 140 °C it can be vapour-sterilised without any difficulty. In medical technology PVDF is often used for pipework systems (e.g. dialysers).
Rapid Prototyping
Rapid prototyping involves a number of different processes for the rapid production of prototypes. Following rapid tooling and rapid prototyping is the production mould and the production-ready product. Rapid tooling and rapid prototyping allow engineering costs to be reduced and development engineering times shortened. Rapid prototyping precedes rapid tooling.
Rapid Tooling
Rapid tooling is the collective term for fast tool manufacture using state-of-the-art methods. Cost advantages and fast availability of pre-production moulds make this a particularly attractive method. Prototype polymer parts should be produced under near-series conditions.
Clean room
The aerial particle contamination in a clean room is held under a certain amount. Clean rooms are particularly needed in medical technology and semiconductor industry. In medical technology the attention is focused on the prevention of contamination with organic material (DNA, RNA, pyrogene, germs etc.). The semiconductor industry tries to avoid particles because they could block or destroy microscopically small structures on microchips. GEMÜ has clean rooms under class 8, 7 and 6 for injection moulding and under class 5 for assembly, testing and packaging activities.
Injection moulding
With this method, plastic parts can be produced in large number. Therefore, the material (mostly plastic) is plastified in an injection unit and injected in an injection moulding tool. The cavity of the tool defines shape and surface structure of the part. Producible are items from tenth parts of grams up to the two-digit kilogram-area. With injection moulding, items can be produced with high accuracy, for example for precision engineering and mass products, in short time. The surface of the item can be chosen almost freely. Possible are smooth surfaces for optical applications, grains for contacted areas, patterns and engravings. Injection moulding is mainly reasonable for huge amounts. The costs for the injection tool are the main part of the necessary investment. Effectiveness is only guaranteed when producing several thousand items of the same part. On the other hand the tools can be used for the production of up to several million pieces. More information about injection moulding can be found here.
(Source: Wikipedia)
