MEDICAL & HEALTHCARE

Silicone Parts for
Medical Applications

ISO 13485 certified. USP Class VI materials. Cleanroom LSR molding available for critical-care components.

ISO 13485USP Class VIFDA 21 CFR 177.2600ISO 10993Class 100 Cleanroom

Precision Medical-Grade Silicone Components

From oxygen concentrator valves to wearable health monitor seals, we manufacture life-critical silicone components with full traceability. Our Class 100 cleanroom and ISO 13485 quality system ensure every part meets the most demanding medical standards.

Primary Material	Platinum-cured LSR (USP Class VI)
Hardness Range	Shore A 20-80
Tolerance	+/- 0.02mm (precision LSR)
Lead Time	15-25 days (T1 samples)

Typical Medical Silicone Parts

These are example part types. Your component may be similar — upload your drawing to get a quote.

LSR Valves & Diaphragms

Platinum-cured LSR, low extractables. For oxygen concentrators, ventilators, and infusion pumps. One-way check valves, pump diaphragms, flow control valves.

Material:	Platinum-cured LSR
Hardness:	Shore 30A-70A
Process:	LSR Injection Molding

Patient-Contact Seals & Masks

Biocompatible silicone seals for diagnostic devices, wearable health monitors, CPAP mask cushions, and disposable medical tools. Hypoallergenic, soft-touch.

Material:	USP Class VI LSR
Hardness:	Shore 20A-50A
Process:	LSR Injection Molding

Peristaltic Pump Tubes & Fluid Paths

LSR extrusion with precise inner-diameter control. Smooth surface for consistent fluid flow. Spallation-resistant for long pump life.

Material:	Platinum-cured LSR
Hardness:	Shore 50A-65A
Process:	LSR Extrusion

Surgical Instrument Components

Retractor tips, graspers, insulating sleeves. Autoclavable at 134C. Color-coded for quick identification in surgical trays.

Material:	Medical HTV Silicone
Hardness:	Shore 60A-80A
Process:	Compression Molding

Material Selection for Medical

Material	Temp Range	Key Property	Typical Use
LSR (Liquid Silicone)	-50C to 200C	Biocompatible, low extractables	Valves, seals, tubes
HTV (High-Temp Vulcanizing)	-50C to 250C	Cost-effective, autoclavable	Instrument grips, tips
Fluorosilicone (FVMQ)	-60C to 175C	Fuel & chemical resistant	Diagnostic equipment seals

Application Showcase

LSR Micro Valves

Check valves and flow control components for infusion pumps and ventilators. Tolerance: +/-0.02mm.

Cleanroom Production

Class 100 cleanroom LSR injection molding with full environmental monitoring and traceability.

Why Medical Brands Choose THOR-SOFT

⚒

ISO 13485 System

Full QMS compliance with design controls, risk management, and CAPA. Audit-ready documentation.

🔐

Material Traceability

Lot-level traceability from raw material to finished part. CoA provided with every shipment.

🔬

Biocompatibility Data

USP Class VI and ISO 10993 test reports available. Cytotoxicity, sensitization, irritation.

⚡

Rapid DFM Feedback

24-hour DFM review on new projects. Tooling flow analysis and mold flow simulation included.

Developing a Medical Device?

We support NPI (New Product Introduction) with DFM feedback, material traceability, and ISO 13485-compliant inspection reports.

GET A QUOTE

NDA available. USP Class VI material certs included with every shipment.

Silicone Parts for Medical Applications