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Produits « Science de la Vie »

Mitsubishi Chemical Advanced Materials possède une grande expérience dans le développement, la fabrication et la fourniture de plastiques techniques utilisés dans les applications médicales et des sciences de la vie. Travaillant en étroite collaboration avec des fabricants d’appareils médicaux, Mitsubishi Chemical Advanced Materials comprend les aspects techniques, réglementaires et de conformité associés à l’utilisation de polymères dans les applications médicales et des sciences de la vie, y compris les matériaux pour les implants médicaux. C’est pourquoi Mitsubishi Chemical Advanced Materials peut vous indiquer le bon choix technique conforté par une expertise en matière réglementaire et de conformité.

 

Ketron CLASSIX™ LSG PEEK stock shapes are produced from Invibio® PEEK-CLASSIX White resin. This material has a maximum body contact duration of 30 days and exhibits a unique combination of mechanical properties, temperature and chemical resistance. The composition of the Invibio PEEK-CLASSIX White resin complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs. Ketron CLASSIX™LSG  PEEK stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to an excellent sterilizability by means of steam, dry heat, ethylene oxide, plasma and gamma irradiation, make Ketron CLASSIX™ LSG PEEK stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets.

Ketron® LSG PEEK stock shapes (colours: natural, black) are produced from selected batches of PEEK polyetheretherketone resin. This material exhibits a unique combination of mechanical properties, temperature and chemical resistance. The composition of the resin used for the production of the Ketron LSG PEEK stock shapes complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs.

Ketron LSG PEEK stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to an excellent sterilizability by means of steam, dry heat, ethylene oxide, plasma and gamma irradiation, make Ketron LSG PEEK stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets.

This 30% carbon fiber reinforced grade combines high stiffness, mechanical strength and creep resistance with an optimum wear resistance. Ketron LSG CA30 PEEK stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to an excellent sterilizability by means of steam, dry heat, ethylene oxide, plasma and gamma irradiation, make Ketron LSG CA30 PEEK stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets.

This specially developed grade is a unique engineering PEEK based composite which offers a high performance profile due to its woven carbon reinforced structure. Perfect for reducing weight in critical instruments, Ketron LSG CC PEEK has a higher specific strength (strength to weight ratio) than Stainless Steel, Aluminum or Titanium.

Its key properties include superior mechanical strength and stiffness at elevated temperatures, outstanding friction and wear resistance, as well as excellent performance in chemical an irradiated environment.

Properties and benefits

  • Significantly higher E-Modulus at 54 GPa (Ketron® CA30 PEEK -> 9,200 MPa)
  • High mechanical strength and stiffness
  • Radiolucent
  • Ability to be precisely machined
  • Dimensional stability following multiple sterilizations
  • Biocompatible
  • Light weight

Applications

  • Target devices in Osteosynthesis

Sultron® LSG PPSU stock shapes are produced from selected batches of a specific Sultron® PPSU polyphenylsulfone resin. This material offers a better impact strength and chemical resistance than Duratron® LSG PEI and Sultron® LSG PSU and it also has superior hydrolysis resistance as measured by steam autoclaving cycles to failure. The composition of the resin used for the production of the Sultron® LSG PPSU stock shapes complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs. Sultron® LSG PPSU stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to an excellent sterilizability by means of steam, dry heat, ethylene oxide, plasma and gamma irradiation, make LSG PPSU stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets.

Sultron® LSG PSU stock shapes are produced from selected batches of a specific polysulfone resin. This polymer shows a combination of very good mechanical, thermal and electrical properties combined with a good hydrolysis and chemical resistance. The composition of the resin used for the production of the Sultron® LSG PSU natural stock shapes complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs. Sultron® LSG PSU natural stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to a good sterilizability by means of steam, dry heat, plasma, ethylene oxide and gamma irradiation, make Sultron® LSG PSU natural stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets.

Altron™ LSG PC stock shapes are produced from selected batches of a specific non-UV-stabilized polycarbonate resin. This polymer shows a combination of good mechanical, thermal and electrical properties combined with a good chemical resistance. The composition of the resin used for the production of the LSG PC stock shapes complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs. Altron™ LSG PC stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to a good sterilizability by means of ethylene oxide, plasma and gamma irradiation, make Altron™ LSG PC stock shapes suitable for applications in the medical, pharmaceutical and biotechnology markets.

Duratron® LSG PEI stock shapes are produced from selected batches of a specific Ultem polyetherimide resin. This polymer shows a combination of outstanding mechanical, thermal and electrical properties combined with a good hydrolysis and chemical resistance. The composition of the resin used for the production of the Duratron LSG PEI stock shapes complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs. Duratron LSG PEI stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to a very good sterilizability by means of steam, dry heat, ethylene oxide, plasma and gamma irradiation, make Duratron LSG PEI stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets.

Mitsubishi Chemical Advanced Materials’s Proteus® LSG HS PP (heat-stabilized Polypropylene) exhibits a heat deflection temperature that allows the material to be used in repeated steam and autoclave sterilization cycles. It is highly resistant to cleaning agents, disinfectants and various solvents. Typical applications for Proteus® LSG HS PP include surgical trays, caddies and instrument components.

The production process includes a special heat-treatment phase that allows for the higher heat deflection temperature and, thus, improved machinability and dimensional stability. Under the label of Mitsubishi Chemical Advanced Materials’s Life Science Grades (LSG), Proteus® LSG HS PP shapes are tested and certified for biocompatibility per ISO10993-5 to ensure quality throughout the entire manufacturing process. This offers the designer increased safety, approval facilitation, as well as reduced cost and time to market.

The material is available as plates in white and black (standard colors); other colors can be produced on a make to order (MTO) basis.

Biocompatibility Testing

Our portfolio of Life Science Grades (LSG) has been tested to ISO 10993 and USP guidelines.

Biocompatibility Table



MediTECH® Implantable Polymers

Implant products made from Mitsubishi Chemical Advanced Materials' biocompatible polymers help millions of patients around the world to maintain or restore a high quality of life. Discover the opportunities of our Longterm Implantation products Zeniva® PEEK and Chirulen®/Extrulen® UHMW-PE.

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