Silicone medical parts are components made from specialized silicone materials that are manufactured into devices or implants used within the healthcare industry. These parts are valued for being biocompatible, durable, and stable, making them suitable for everything from disposable medical tubing to long-term implants.medical grade silicone is the key for these parts,
silicone meterial must meet ISO 10993,USP class VI,GB/T 16886 certification,moreover,some projects require to meet strict implants requirement.
Low Tissue Reaction: Medical-grade silicone is inert and doesn’t trigger significant immune rejection, chronic inflammation, or allergic reactions when contact with skin, tissue, or blood.
Non-Cytotoxic: medical grade silicone passes rigorous USP Class VI and ISO 10993 , confirming it does not harm living cells, which is essential for implants and wound care.
Resists Degradation: silicone is not easily broken down, brittle, or harmful plasticizers (like phthalates or BPA) with the body. This stability is vital for long-term implants and drug delivery systems.
Withstands Sterilization: medical grade silicone can endure multiple sterilization methods without losing its physical properties, including steam autoclaving (high temperatures), ethylene oxide (ETO) gas, gamma radiation, and e-beam processing. This ensures devices can be thoroughly sterilized for safe reuse or initial implantation.
Tunable Softness: It can be formulated from a soft, cushioning gel (for scar pads, prosthetic liners) to a firm, supportive elastomer (for orthopedic implants, long-term catheter walls). This minimizes compression and friction against delicate body tissues.
Breathability & Permeability: Silicone is highly permeable to gases (oxygen, carbon dioxide CO₂) and water vapor. This is a critical advantage for wound care dressings and extended-wear contact lenses, allowing the skin to “breathe” while maintaining a protective barrier.
Dynamic Elasticity: It has outstanding flexural fatigue resistance—meaning it can be flexed, stretched, or compressed millions of times (as in peristaltic pump tubing or heart valves) without cracking or deforming
Proven Clinical History: With over 50 years’ using in medicine, silicone’s long-term effects are well-documented and understood by clinicians and regulatory bodies. The systemic toxicity risk is exceptionally lower than many new material alternatives.
Predictable Shelf Life: medical grade silicone has long shelf life without storage degradation, making it cost-effective for manufacturing and hospital inventory.
Low Tissue Reaction: Medical-grade silicone is inert and doesn’t trigger significant immune rejection, chronic inflammation, or allergic reactions when contact with skin, tissue, or blood.
Non-Cytotoxic: medical grade silicone passes rigorous USP Class VI and ISO 10993 , confirming it does not harm living cells, which is essential for implants and wound care.
Resists Degradation: silicone is not easily broken down, brittle, or harmful plasticizers (like phthalates or BPA) with the body. This stability is vital for long-term implants and drug delivery systems.
Withstands Sterilization: medical grade silicone can endure multiple sterilization methods without losing its physical properties, including steam autoclaving (high temperatures), ethylene oxide (ETO) gas, gamma radiation, and e-beam processing. This ensures devices can be thoroughly sterilized for safe reuse or initial implantation.
Tunable Softness: It can be formulated from a soft, cushioning gel (for scar pads, prosthetic liners) to a firm, supportive elastomer (for orthopedic implants, long-term catheter walls). This minimizes compression and friction against delicate body tissues.
Breathability & Permeability: Silicone is highly permeable to gases (oxygen, carbon dioxide CO₂) and water vapor. This is a critical advantage for wound care dressings and extended-wear contact lenses, allowing the skin to “breathe” while maintaining a protective barrier.
Dynamic Elasticity: It has outstanding flexural fatigue resistance—meaning it can be flexed, stretched, or compressed millions of times (as in peristaltic pump tubing or heart valves) without cracking or deforming
Proven Clinical History: With over 50 years’ using in medicine, silicone’s long-term effects are well-documented and understood by clinicians and regulatory bodies. The systemic toxicity risk is exceptionally lower than many new material alternatives.
Predictable Shelf Life: medical grade silicone has long shelf life without storage degradation, making it cost-effective for manufacturing and hospital inventory.
Certification selon les normes ISO 9001, ISO 14001, ISO 13485 et la FDA
Cooperation with major medical silicone suppliers in domestic and foreign like Wacker, Dow Corning, Momentive, and Wynca
Plus de 25 ans d'expérience dans le développement et la fabrication
Offer complete process service, including design,
technology, production, package.
A class 100,000 cleaning room.
Respiratory masks, headstraps,intubation tubes, nebulizer
Plunger and stoppers, puncture gaskets; flexible connectors for infusion pipelines, shock-absorbing membranes for drip chambers; one-way silicone check valves, liquid medicine sealing bladders; Oxygen nasal cannula.
lone lifespan.
Rehabilitation gloves, grip training balls,massager parts,Anti smog mask.
Long-term implantable prostheses for human bodies,Internal pipeline and shunt components,Implantable sealing and buffer parts
ISO 13485 factory quality management system
ISO 10993 biocompatibility test report (cytotoxicity, irritation, sensitization)
RoHS, REACH, FDA 21 CFR Part 177 food & medical contact compliance
latex-free, PVC-free formula available
Platinum curing agent is widely used in medical parts.with platinum vulcanizing agents,silicone medical parts have low extractables, stronger tear resistance, and meet biocompatibility requirements.
Autoclave,Gamma Irradiation,ETO are commenly used for sterilization of silicone medical products
Regular medical silicone is suitable for short-term contact (<30 days). Long-term implant parts need implant-grade silicone with extra cytotoxicity, hemolysis, chronic irritation testing according to ISO 10993-6/-10.
Notre équipe d'assistance est disponible en ligne 24 heures sur 24, 7 jours sur 7.
Personne à contacter : Wendy Huang
E-mail : Wendy@xmoti.com
Tél. : +86-592-5218891
WhatsApp: +86-18950122603
Mob : +86-18950122603
