I. Core Requirements and Material Selection Criteria for Medical Earmuffs
Medical earmuffs must meet four core requirements: biocompatibility, wearer comfort, sterilization resistance, and processing efficiency:
Biocompatibility: Comply with ISO 10993, FDA, and other medical certifications to avoid allergic or toxic risks.
Wearing Comfort: Soft touch and lightweight design for extended wear.
Sterilization Resistance: Withstands high-temperature steam, UV rays, and chemical disinfectants.
Processing Efficiency: Injection molding offers a short cycle time, suitable for mass production.
II. Comparative Analysis of TPE and Silicone Performance
Performance Dimensions
TPE (Thermoplastic Elastomer)
Silicone (Silicone Rubber)
Biocompatibility
Requires special formulations to meet medical standards (e.g., halogen-free, plasticizer-free). Some models are FDA-approved.
Naturally inert, widely ISO 10993-certified, and more compatible with human tissue.
High-Temperature Resistance
Conventional temperature range: -40°C to 120°C; special modifications can reach 150°C, but prolonged exposure to high temperatures can lead to degradation.
Temperature range: -60°C to 250°C. Can withstand repeated high-temperature sterilization (e.g., 121°C). Steam sterilizable)
Flexibility
Low elastic modulus (hardness 0A-90A), allowing for ultra-thin designs that conform to the ear contours
Narrow hardness range (10A-80A), strong resilience, but prone to deformation with long-term compression
Surface feel
Skin-like texture, surface treatment can reduce dust pick-up, but prone to injection flow marks
Smooth and delicate touch, excellent antistatic properties, and low dust absorption
Processing efficiency
Short injection molding cycle (no vulcanization required), 100% recyclable scrap, reducing overall costs by 30%-50%
Requires vulcanization molding, long cycle times (measured in minutes), non-recyclable waste, and high mold costs
Chemical resistance
Resistant to weak acids and bases, but susceptible to swelling with prolonged contact with oils, fats, or strong oxidizers
Oil-resistant, acid- and base-resistant (except hydrofluoric acid and strong bases), suitable for contact with disinfectants (such as alcohol and sodium hypochlorite)
III. Scenario-specific recommendations for medical earmuff material selection
1. High-Frequency Sterilization Scenarios (e.g., Operating Rooms)
Recommended Silicone: Resistant to high-temperature steam sterilization, offering superior long-term stability.
Note: Mold design optimization (e.g., multi-point injection) is required to reduce curing time and increase production capacity.
2. For Children/Patients with Sensitive Skin
Recommended Medical-Grade TPE: Lightweight (density 1.0-1.2 g/cm³) reduces ear pressure, and customizable colors enhance compliance.
Note: Skin irritation testing is required to avoid residual volatile substances.
3. Low-Cost, High-Volume Production
Recommended TPE: High injection efficiency (cycle time < 30 seconds), with raw material costs 40%-60% lower than silicone.
Note: Anti-aging agents may be added to extend service life.
IV. Industry Trends and Innovation Directions
TPE Modification Technology: Develop high-temperature-resistant TPE (e.g., dynamically vulcanized TPV) to break through the 120°C temperature resistance bottleneck.
Silicone Injection Molding Process: Liquid silicone rubber (LSR) injection molding technology shortens curing time and improves production efficiency.
Composite Material Application: TPE/silicone dual-layer injection molding combined with an antimicrobial surface coating balances comfort and functionality.
V. Summary
TPE and silicone each have their own advantages and disadvantages in the medical earmuffs field:
Silicone: Suitable for high-end applications requiring frequent disinfection and long-term use, but carries a higher cost.
TPE: Meets lightweight and low-cost requirements, but requires formulation optimization to enhance aging resistance.
ZIBO HUIWEN Plastics offers a full range of plastic molding capabilities to efficiently mass-produce parts specializing in injection molding and have served customers in variety of industries such as medical, automotive, packaging, construction, home appliances , and agriculture. The company has two factories which occupy a total area of more than 18,000 square meters, and a total of 102 sets of injection molding machines .
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