Custom Medical Silicone Disc Component | LSR Injection Molding

Parameter Category

Specification / Property

Standard / Value

Remarks / Application

Material & Certification

Material Grade

Medical Grade LSR (Platinum-Cured)

USP Class VI, ISO 10993, FDA 21 CFR 177.2600 compliant

Quality Management System

ISO 13485:2016 Certified

Full traceability for medical device manufacturing

Physical Properties

Hardness (Shore A)

10 A to 80 A

Customizable based on component function (e.g., soft seals, rigid housings)

Tensile Strength

≥ 8 MPa

Ensures durability and tear resistance in dynamic applications

Elongation at Break

≥ 400%

Provides excellent flexibility and elongation for safety

Tear Strength

≥ 25 kN/m

Resists nicking and propagation of tears

Performance Properties

Temperature Resistance

-50°C to +200°C

Suitable for autoclaving (steam sterilization) and cryogenic conditions

Biocompatibility

Certified

Non-toxic, non-allergenic, supports long-term skin/fluid contact

Transparency

Optically Clear to Opaque

Available in full range; clarity ideal for fluid monitoring components

Compression Set (22 hrs @ 175°C)

≤ 20%

Maintains seal integrity after repeated sterilization cycles

Surface & Processing

Surface Finish

Medical Smooth, Textured, or Custom

Minimizes bacterial adhesion; customizable for grip or aesthetics

Color

Natural, Standard Pantone, or Custom

Non-migrating, pigment masterbatches compliant with medical standards

Secondary Operations

Bonding, Printing, Assembly

Can be securely bonded to plastics, metals, or other substrates

Customization & Service

Manufacturing Process

Liquid Silicone Injection Molding (LSR/LIM)

Precision molding for complex, flash-free, high-volume parts

Tolerances

Tight, ISO 20457 (DIN 7715)

Meets medical component dimensional requirements

Services Offered

Full OEM & ODM

From design & prototyping to validation, packaging, and logistics

Lead Time for Prototypes

2-4 weeks

Subject to project complexity