Biocompatibility

What is biocompatibility?

Materials are described as biocompatible if they do not trigger any harmful biological reactions on contact with human or animal bodies. Biocompatibility plays a central role in medical products in particular and its verification is part of the technical documentation of the products.

What does biocompatibility mean?

Biocompatible materials do not cause toxic, allergenic or inflammatory reactions in body tissue. Proof is essential for products that:

are in direct contact with body fluids or tissue
can be implanted temporarily or permanently
can be worn internally or externally on the body

Biocompatibility depends not only on the base material, but also on additives, processing and surface properties.

How is biocompatibility verified?

Evidence from biological tests and toxicological assessments are defined in ISO 10993-1 ff. and may include the following tests, among others:

Genotoxicity test (ISO 10993-3 tests for genotoxicity, carcinogenicity and reproductive toxicity)
Cytotoxicity test (ISO 10993-5 tests for in vitro cytotoxicity)
Irritation test (ISO 10993-10 Tests for irritation and skin sensitisation)
Chemical characterisation (ISO 10993-18 Chemical characterisation of materials)

The tests are carried out in accordance with ISO 10993-1 ff. and documented by accredited test laboratories. However, a corresponding material certificate from the component supplier is always only partial proof. The OEM is responsible for the complete biocompatibility assessment.

Is rubber biocompatible?

Rubber can be biocompatible. This applies in particular to Silicones, which are standard materials in medical technology.

Further entries

Shaft seal

A shaft seal is a sealing element that seals between a rotating shaft and a housing. It prevents lubricants from escaping and at the same time protects against dirt, dust and moisture.

Anti-ageing agent

Anti-ageing agents are functional additives that protect elastomers and plastics from damaging influences such as oxygen, ozone, UV radiation or heat, thereby significantly extending their service life.

Extrusion of rubber

Rubber extrusion is a continuous manufacturing process for rubber-elastic profiles, hoses and seals in which the material is pressed through a moulding die and then vulcanised.

Injection moulding

Injection moulding is a precise moulding process for manufacturing complex plastic and rubber parts in which the material is injected into a mould under pressure and cured there.

EPDM: Ethylene propylene diene rubber

EPDM is a weather, UV and chemical-resistant elastomer with high thermal stability that is used in particular for durable seals, hoses and outdoor applications in industry and construction.

Copolymerisation

Copolymerisation is the simultaneous polymerisation of different monomers to produce polymers with specifically adjustable properties for technical and industrial applications.

Tensile strength

The tensile strength is the maximum stress that a material can withstand under tensile load and is a key parameter for the mechanical strength of elastomers.

Deburring

Deburring is the process of removing burrs from components to ensure the function, appearance and safety of technical products.

DIN ISO 3302-1

DIN ISO 3302-1 defines the general tolerances for moulded rubber parts and is an international standard for ensuring dimensional accuracy in elastomer processing.

Seals

Seals prevent leaks in pipework, motor and system components. They also compensate for manufacturing tolerances and protect processes against pressure, temperature and media stress.

Bellows

A bellows is an elastic component with a corrugated, accordion-like geometry that absorbs movements, changes in length or swivelling movements without losing its protective or sealing function. It protects sensitive components such as joints, shafts or guides from dirt and moisture and at the same time enables a flexible, permanently movable connection.

PA: Polyamide

Polyamide (PA) is a robust, wear-resistant plastic with very good strength and chemical resistance, which is used in particular in technical components and rubber-plastic composite systems.

Metal oxide crosslinking

Metal oxide crosslinking is a crosslinking process that is mainly used for chloroprene rubber and produces particularly durable, ageing and flame-resistant rubber parts.

Polyurethane (PU)

Polyurethane (PU) is a robust, abrasion-resistant plastic with high elasticity and chemical resistance, which is primarily used in heavily loaded technical components, dampers and composite solutions.

GRP: Glass fibre reinforced plastic

GRP (glass fibre reinforced plastic) is a robust, lightweight composite material made from glass fibres and a plastic matrix that is used in a wide range of applications in industry, construction and mobility.

Vulcanisation

Vulcanisation is the process in which raw rubber is converted into a permanently elastic, dimensionally stable and durable rubber state through chemical cross-linking.

Cold resistance

Cold resistance describes the ability of a material to remain functional and elastic at low temperatures - crucial for seals and elastomer components in outdoor or cold applications.

Sulphur crosslinking

Sulphur crosslinking is a proven vulcanisation process in which rubber is crosslinked with the aid of sulphur to form an elastic, dimensionally stable and mechanically resilient material.

Residual materials

Residual materials are recyclable material residues from production that can be specifically collected and fed back into the production cycle to conserve resources.

HTV silicone: High-temperature curing solid silicone

HTV silicone is a high-temperature curing solid silicone rubber that becomes a permanently elastic material when heated. It combines high mechanical strength with excellent resistance to temperature, ageing and chemicals.

Adhesion promoter

Adhesion promoters are chemical bonding agents that permanently bond rubber with other materials and thus form the basis for resilient rubber composite parts.

Saturated and unsaturated polymers

Saturated polymers have only single bonds in the main chain and are resistant to ageing, while unsaturated polymers contain double bonds in the main chain and are easier to crosslink; EPDM is a speciality because its double bond is in the side chain.

FDA conformity

FDA compliance means that a material or product meets the requirements of the U.S. Food and Drug Administration and is safe for contact with food, drinking water or pharmaceutical applications. Only approved ingredients may be used and the material must not release any substances of concern into the medium.

RoHS

RoHS restricts the use of certain hazardous substances in electrical and electronic equipment in order to reduce environmental and health risks. Products may only be sold in the EU if all components comply with the specified limits for listed hazardous substances.

Freeze deburring

Freeze deburring is a process for removing burrs, particularly on rubber parts, by cooling and mechanical blasting.

Degreasing

Degreasing is an essential cleaning step for removing residues from components to ensure optimum adhesion during vulcanisation, bonding or coating.

Tool cleaning

Tool cleaning ensures reliable, clean moulding, protects against burr formation and extends the service life of tools in series production.

Protective housing

A protective housing encapsulates sensitive components and prevents damage caused by dirt, water or impact.

ISO 14001

ISO 14001 explained: an overview of the requirements, areas of application and benefits of the international standard for environmental management systems.

ISO 9001

ISO 9001 is the world's most important standard for quality management. It defines how companies manage their processes so that products and services deliver consistently high quality and fulfil customer requirements.

VMQ: Silicone rubber

Silicone rubber (VMQ) is a heat-, cold- and UV-resistant elastomer with very good insulation and media resistance, which is frequently used in medical, food and automotive technology.

Structural steel: S235 and S355

Structural steel (S235, S355) is a robust, easily weldable construction steel that is used as a stable carrier material in load-bearing structures, machine components and rubber-metal composite parts.

Vacuum cups

Suction cups are suction cups made of elastomer or plastic that cling elastically to the surface and trap the resulting vacuum. Suction cups create an adhesive connection between the gripper and the workpiece by means of negative pressure.

Sealed seats

Sealing seats are machined contact surfaces that accommodate seals in a form-fit and force-fit manner, thus ensuring permanent media separation protection.

NR: Natural rubber

Natural rubber (NR) is a highly elastic, tear-resistant elastomer made from renewable raw materials that is primarily used in dynamically stressed components such as tyres, dampers and conveyor belts.

Series production

Series production refers to the repeated, economical manufacture of similar components in large quantities.

FKM: Fluororubber

FKM is a heat- and chemical-resistant high-performance elastomer for seals and components in extremely demanding industrial applications.

Glass transition temperature

The glass transition temperature (Tg) is the temperature range in which a polymer changes from elastic to glassy and largely determines its low-temperature flexibility.

PPA: Polyphthalamide

Polyphthalamide (PPA) is a dimensionally stable, chemical and temperature-resistant high-performance plastic that is used in particular for precise, media-resistant components and rubber-plastic composite solutions.

NBR: Acrylonitrile butadiene rubber

Acrylonitrile butadiene rubber (NBR) is an oil and fuel-resistant elastomer that is frequently used for seals, hoses and technical moulded parts in mechanical engineering and vehicle construction.

Express Services

Express production refers to the particularly fast production of prototypes, tools or small batches and accelerated development projects with drastically reduced delivery times.

Rubber-Metal Composite Parts

Rubber-metal composite parts are mechanically stable components in which elastomer and metal are inseparably combined - ideal for bearings, dampers and technical sealing systems.

LSR: Liquid silicone

LSR is a liquid silicone rubber produced on a VMQ or FVMQ basis and processed by injection moulding. The material combines high elasticity, purity and temperature resistance.

FVMQ: Fluorosilicone

FVMQ is a cold-flexible, fuel- and weather-resistant fluorosilicone elastomer that is primarily used in the aviation and automotive industries for demanding sealing applications.

Crosslinking chemicals

Cross-linking chemicals ensure the permanent elasticity and dimensional stability of rubber through chemical reaction - a key component in the production of functional rubber parts.

Rubber expansion joints

Rubber expansion joints are flexible connecting elements that compensate for movements, vibrations and pressure surges in pipework. Thanks to their elastic structure, they can absorb changes in length, lateral displacements and angular movements and thus protect connected system components from mechanical stress, vibrations and tension in the pipework system.

brass

Brass is an easily machinable, corrosion-resistant copper-zinc alloy that is widely used as a functional and decorative metal - including in rubber-metal composite parts, fittings and electrical components.

Elongation at break

The elongation at break indicates how much a material can stretch under tensile load before it tears.

Stainless steel

Stainless steel is a corrosion and temperature-resistant material that is used for durable, hygienic and mechanically resilient components in demanding technical applications.

Rubber buffers

Rubber buffers are elastic elements that absorb and dampen shocks, oscillations and vibrations. They protect machines, devices and assemblies from mechanical loads, compensate for movements and reduce noise in technical applications.

Biocompatibility

The proof of biocompatibility proves through standardised tests that a medical device or material does not cause any harmful reactions in the human body.

Calendering

Calendering is a rolling process in which rubber or plastic compounds are rolled between heated rollers. In addition to the manufacture of finished products such as rubber mats, it is primarily used in the production of rubber blanks.

Azo and urea compounds

Azo and urea compounds are speciality chemicals that are used as blowing or cross-linking agents in rubber processing - especially for foams and friction-active components.

Vibratory finishing (barrel finishing)

Mass finishing or barrel finishing is a mechanical mass finishing process in which surfaces are machined and burrs removed using abrasive media and movement.

Assembly Services

Component assembly comprises the assembly of individual components into a functional unit as an assembly.

Aramid / Kevlar

Aramid / Kevlar is an extremely tensile, lightweight and heat-resistant fibre that is used as reinforcement in rubber composite parts, sealing systems and protective applications.

Suction pad

Suction cups are cup-shaped suction cups made of elastomer or plastic that cling elastically to the surface and trap the resulting vacuum. Suction cups create an adhesive connection between the gripper and the workpiece by means of negative pressure.

Toolmaking

In elastomer production, toolmaking refers to the development and manufacture of high-precision tools that are used in the production of rubber, plastic and composite parts for moulding.

Inserts

Inserts are solid components that are embedded in rubber components during processing in order to specifically extend their functionality, stability or fastening options.

TPE: Thermoplastic elastomers

TPEs are elastic, malleable materials with rubber-like behaviour that can be thermally processed and recycled like plastics - ideal for flexible seals, handles and hybrid parts.

Polymerisation

Polymerisation is the chemical reaction in which many monomers are combined to form long polymer chains - the basis for plastics and rubber elastomers.

CAD modelling

CAD modelling is the digital design of technical components and tools that serves as the basis for production, simulation and prototype development in industry.

Cycle time

The cycle time describes the complete duration of a production run during injection moulding or pressing and is a key parameter for efficiency and output.

Ageing

Ageing describes the gradual change in material properties due to external influences such as heat, UV radiation or media, which can lead to long-term impairment of function and service life.

IRHD hardness (International Rubber Hardness Degree / ball indentation hardness)

IRHD hardness is an internationally standardised method for measuring rubber hardness using ball pressure and is particularly suitable for small or sensitive elastomer components.

ABS: Acrylonitrile butadiene styrene

Acrylonitrile butadiene styrene (ABS) is a robust, impact-resistant and easy-to-process plastic that is used for housings, interior parts and rubber-plastic composite components with high surface and dimensional stability requirements.

Caoutchouc vs. rubber vs. elastomer

Rubber is the raw material, rubber is the end product created by vulcanisation, and elastomer is the superordinate material class of elastic polymers.

Rebound resilience

Rebound resilience describes the ability of a material to return energy after rapid deformation - crucial for dynamic applications such as spring elements or dampers.

Plasticiser

Plasticisers are additives that make rubber and plastics more elastic and easier to process and are mainly used in flexible sealing and moulded parts.

Rubber blank

A rubber blank is a non-crosslinked, mouldable elastomer precursor that is processed in moulding tools to produce elastic rubber parts.

Heat resistance

Heat-resistant materials retain their properties at high temperatures and are ideal for industrial and technical applications.

Oil resistance

Oil-resistant materials permanently withstand aggressive oils and are used in seals, hoses and technical components.

Pressure resistance

Pressure resistance is the resistance of a material to compressive stress and is a decisive factor for the function and service life of technical components under mechanical stress.

Rubber-fabric composite parts

Rubber-fabric composite parts are elastic components with integrated fabric inserts that ensure high tensile strength, dimensional stability and dynamic load-bearing capacity - for example in membranes, seals or conveyor belts.

Elastomer rollers

Rubber rollers transmit forces, dampen vibrations and protect surfaces in printing machines, conveyor systems and packaging lines.

Tempering

Annealing is a thermal post-treatment that reduces residual stresses, stabilises material properties and improves the functionality of technical components.

Mould cavity / cavity

Mould cavities are the cavities in a mould that give the component its final geometry during the moulding process.

Grommets

Grommets are ring- or disc-shaped protective inserts that are inserted into openings or edges to allow cables to pass through safely. Grommets protect cables and hoses from sharp edges, seal feed-throughs and can be quickly inserted into holes or gaps.

Bearing bolt

A bearing pin is a cylindrical connecting element that serves as a pivot or swivel axis for moving components. It transmits forces, guides movements and secures the position of components within a bearing or a joint connection.

Compound

A compound is a customised material mixture of polymer and additives that is specifically tailored to the requirements of a particular technical application.

Medical device regulation (MDR)

The Medical Device Regulation (MDR) is the central EU regulation for medical devices, which places high demands on safety, documentation and market surveillance.

Elasticity

Elasticity is the ability of a material to deform under load and then return completely to its original shape - essential for flexible technical components.

Sampling

In engineering, sampling is the testing and approval of sample parts of a new or revised product or manufacturing process.

CR: Chloroprene rubber

Chloroprene rubber (CR) is a versatile, weather- and flame-resistant elastomer that is often used for seals, hoses and technical components for indoor and outdoor use and is also known as neoprene.

ISO 13485

ISO 13485 explained: an overview of the requirements, areas of application and benefits of certification for medical technology.

Sealing lips

Sealing lips are flexible sealing elements that securely enclose media and remain reliably functional even in the event of rotation or pressure fluctuations.

Valve seal

A valve seal is an elastic component that reliably seals the flow of gases or liquids in a valve. The seal prevents leaks, compensates for pressure and temperature changes and ensures that the valve fulfils its switching, control or shut-off function reliably and permanently.

PC: Polycarbonate

Polycarbonate (PC) is a transparent, impact-resistant plastic that is used for high-quality housings, visible parts and functional composite components.

EN 9100

EN 9100 explained: an overview of the requirements, areas of application and benefits of certification for the aviation, aerospace and defence industries.

Abrasion

Abrasion is the mechanically induced surface wear of a material caused by friction and has a decisive influence on the service life and usability of technical components.

Rapid tooling

Rapid tooling is the accelerated production of functional tools for the rapid production of prototypes or small series under near-series conditions.

Engine damper

Engine dampers are elastic elements that absorb vibrations and shocks between the engine and the vehicle or machine frame. They reduce vibrations, protect adjacent components from stress and improve the noise and running behaviour of the entire system.

Synthetic rubber

Synthetic rubber is an industrially manufactured elastomer material that is categorised into main chemical groups and whose properties can be specifically adapted to technical requirements.

Special alloys

Speciality alloys are highly developed metal mixtures for extreme requirements in technology, medicine and industry - especially where corrosion, temperature or load limits of standard materials are exceeded.

Peroxide crosslinking

Peroxides are reactive cross-linking chemicals that produce stable, temperature- and chemical-resistant elastomer structures without sulphur bridges in rubber processing.

Compression moulding

Compression moulding is a process for manufacturing moulded rubber parts in which a rubber compound is compressed under pressure and heat in a closed mould and vulcanised directly.

IIR: Butyl rubber

Butyl rubber (IIR) is a particularly gas-tight, weather- and chemical-resistant elastomer that is mainly used in tyres, seals and membranes.

Shore hardness

The Shore hardness measures how deeply a test pin penetrates a material and thus provides information about its degree of hardness - a decisive factor in the selection of elastic and technical materials.

Molded Rubber Parts

Moulded rubber parts are elastic components made from vulcanised rubber by pressing, transfer moulding or injection moulding. They are manufactured according to drawings and are used as sealing, damping or functional elements in technical applications.

Housing and cover with integrated seal

Housings and covers with integrated seals are components in which the sealing function is embedded directly in the plastic or metal part. The sealing function is usually realised as an overmoulded or pressed-in rubber sealing lip. They enable reliable sealing without a separate sealing component and are often used for compact, easy-to-install assemblies.

Titanium

Titanium is an extremely corrosion-resistant, lightweight and high-strength material that is used in aviation, medical technology and for rubber-metal composite parts in aggressive environments.

RTV silicone: Room temperature curing solid silicone

RTV silicone is a room temperature curing silicone rubber that cures without heat or pressure. It is particularly suitable for sealing, bonding, potting and mould making and is less strong and temperature-resistant than HTV and LSR.

PPS: Polyphenylene sulphide

Polyphenylene sulphide (PPS) is a high-temperature and chemical-resistant precision plastic that is used in media-exposed and dimensionally critical components, especially in hybrid solutions.

Rubber recycling

Rubber recycling includes mechanical, thermal and chemical processes for the reuse of vulcanised rubber products as raw materials or additives in new applications.

Profile seal

A profile seal is a seal with a defined cross-sectional shape (round, rectangular, hollow or with a complex profile) that ensures a seal between two components. It is made from elastomers and is used wherever gaps, movements or unevenness need to be compensated for.

Keyboard and switch covers

Keyboard and switch covers are elastic protective components that protect keys and operating elements from dust, moisture and dirt. At the same time, they maintain the operating function by transmitting the actuation feel and enabling reliable sealing.

Tool costs

Tool costs are the expenses for the manufacture of tools and have a significant influence on the profitability of series production.

SBR: styrene-butadiene rubber

SBR is a cost-effective, abrasion-resistant elastomer with good mechanical properties that is mainly used in tyres, seals and general moulded rubber parts.

PU: Polyurethane elastomer

PU elastomers are dimensionally stable, abrasion-resistant plastics with high mechanical strength that are ideal for rollers, seals and shock absorbers in heavy-duty industrial applications.

Primer

Primers are adhesion-promoting primers that improve the adhesion between rubber, plastic or metal and ensure a permanent bond in composite and coating applications.

Burr formation

Burr formation occurs in primary forming processes due to material escaping from mould parting surfaces and joints during forming and requires targeted reworking to ensure component quality.

REACH

REACH is an EU regulation for the registration, evaluation and regulation of chemical substances in order to better protect people and the environment. Companies must prove the safety of the raw materials they use and inform customers if their products contain substances of concern.