Medical equipment industry
Hony Plastic has long been committed to the research, development, manufacture and supply of engineering plastic products for medical and life science applications. Mitsubishi Chemical Advanced Materials works closely with medical device manufacturers to understand the technical, standard and regulatory requirements related to the use of polymers in medical and life science applications, including medical implant materials. Therefore, Mitsubishi Chemical Advanced Materials has the knowledge of regulations and various standards to provide you with suitable technology options.
Common Materials
PEI
PSU
PPSU
PP
PI
PC
PFA
PTFE
PCTFE
ECTFE
PPO
FEP
PEEK
Materials Strength
Ø Chemical resistance medical-grade materials possess good chemical resistance to various conventional disinfectants and cleansers
Ø Sterilization performance A great number of our medical-grade plastic materials are very easily sterilizable by means of hot steam , ethylene oxide (ET0),plasma and gamma rays .
Ø Hydrolysis resistance the excellent hydrolysis resistance of our products is indispensable for sterilizable with hot steam
Ø Biocompatibility with the scope of selecting the suitable material for medical-technical application, not only the technical requirements have to be considered , but often it is necessary to ensure the material is compatible with the human organism . The biological assessment of a product is invariably requisite , if there is direct contact of the material or product with the patient .
Ø The extent of such tests depends particularly on the experience already gained for this material in the particular application concerned , and the precise intended use of the medical product (in particular the nature and duration of the physical contact ).
Typical Application
Medical Wands
Sterilization trays and caddies
Endoscopic probes & devices
Handles and grips for instrumentation
Sizing trials for knee and hip replacement
Fixation devices
Endoscopic housings and eyepieces
Parts for X-ray and MRI devices
Components for supports and biopsy units
Blocks and housings for dialysis machines
Pistons and valves for anesthetic equipment
Supports and adaptors for dental instruments
Components for treatment and therapy units
Components for sample changers
Valves housing and nozzles for fluid distribution
Spectrometer parts for chromatography systems
Wear parts for pill and tablet production
Advantage
Standard certification: Hony Plastic' "life science grade products" have been approved and can be used for body and tissue contact for up to 20 hours (Ketron® CLASSIX™ LSG PEEK can last up to 30 days), while meeting the safety requirements of designated agencies and regulatory requirements. These products are developed and tested for biocompatibility in accordance with ISO 10993 and USP requirements. This also helps to speed up the approval of medical devices. In addition, Hony Plastic' "life science grade products" have established a change control process that complies with notifications and change applications. Certificates and documents can also be provided and issued. Hony Plastic is ISO 13485 certified for the development and production of implantable grade UHMW-PE; these products are intended for long-term implantation.
Confidence: Selecting the [right material" for sensitive medical and life science applications by collaborating with a trusted partner on design and feasibility. Hony Plastic has been committed to providing engineering plastic solutions for life science and medical applications for a long time, and has rich experience.
Choice: Hony Plastic can provide a large number of certified engineering plastic products for customers to choose, such as PEEK, PAI, PEI, PPSU, POM, and implantable grade ultra-high molecular weight polyethylene that has been proven in the medical and life science industries product. All products are USP Class VI and ISO 10993 certified.
Capabilities: Hony Plastic specializes in the development of engineering plastic profile molding and injection molding processes to meet the needs of the medical industry.
Serve
Hony Plastic' life science grade products are developed for the medical, pharmaceutical and bioprocessing industries. The life science grade product portfolio of Hony Plastic complies with FDA, ISO 10993 and USP indicators in terms of material biocompatibility testing, so it can save testing costs and time, and at the same time provide full tracking from raw materials to profiles.
Application
Surgical Instruments and Handles
Endoscope components
Trauma: Trays for implants and instruments, marking devices
Surgical Instruments and Handles Orthopedics/Joint Reconstruction: Implants and Trial Implants, Tool Components
Analytical and Diagnostic Equipment
Dental instrument
Imaging device
Anesthesia and Therapy Equipment
Bioprocessing
