Medical equipment silicone accessories, medical grade silicone biocompatibility indicators, energy head factory direct sales

I. Raw Material Description (For Medical Aesthetic / MRI Abdominal Coil Silicone Paddle Decorative Plug, Medical Device Grade)
1. Full Name of Raw Material

Medical-grade Methyl Vinyl Silicone Rubber Compound, Peroxide Curing System

Base Material: Transparent / Matte White Medical Silicone Raw Rubber + Reinforcing Fumed Silica

Auxiliary Materials: Medical Eco-friendly Curing Agent, Inorganic Food-grade Color Powder, Wear-resistant Additives

2. Core Biological Safety Indicators for Medical Devices

Skin Irritation / Sensitization: No primary skin irritation, no delayed hypersensitivity reaction (GB/T 16886.10)

Heavy Metal Leaching: Total leaching of lead, cadmium, mercury and hexavalent chromium ＜10 ppm, compliant with RoHS 2.0

Volatile Organic Compounds (VOC): Low volatility, odor-free; no odor interference to equipment during coil operation

Disinfection Resistance: Resists repeated wiping with alcohol and neutral medical disinfectants; no whitening, swelling or substance precipitation

3. Appearance Adaptability Properties (Specially for Decorative Plugs, Meeting Coil Appearance Requirements)

Matte and delicate surface, free of spray sagging, bubbles and shrinkage marks; matches the double-curved texture of the main unit housing

Low friction coefficient; non-sticky when in contact with human skin, no skin irritation when fitting abdominal curved surfaces

Anti-yellowing: No yellowing after 1000 hours under long-term light exposure / constant-temperature equipment environment, color difference ΔE ≤ 2

Insulation Performance: Volume resistivity ≥ 1×10¹³ Ω·cm, no interference with coil electromagnetic signals (Critical! Compatible with MRI / Electromagnetic Shaping Equipment Coils)

II. Material Performance Indicators & Parameters

III. Production Process
Compression Molding of Solid Silicone Rubber

• Cut silicone rubber sheets with fixed dosage, place them into mold cavities, and perform pressure vulcanization at 160°C for 120~180 seconds on a flat vulcanizing press.

• Integrally molded special-shaped double-curved decorative plugs; suitable for simple-structured accessories with small batch sizes.

Full Inspection
Conduct appearance inspection (check for bubbles, color difference, sink marks and flash burrs) and dimensional measurement with calipers.
Dust-Free Packaging & Warehousing
Individually vacuum-packed in PE bags in a dust-free workshop, with a certificate of conformity and material batch traceability sheet attached.

IV. Product Application Scenarios
This is a decorative plug for the abdominal paddle of professional abdominal coil silicone assemblies. It is made of medical-grade silicone rubber that complies with national standards on biocompatibility for medical devices. The raw material contains no heavy metals or phthalates, features low VOC emission and zero odor.

It is matched with medical-grade color masterbatch, non-silicone migrating release agent and special primer for plastic bonding. The material provides excellent insulation without interfering with the coil’s electromagnetic signals, and poses no risk of skin irritation or sensitization during long-term contact with human skin.