USP Class VI: The Gold Standard for Medical Grade Elastomers.

USP Class VI: The Gold Standard for Medical Grade Elastomers

Problem Statement

Medical-grade elastomers face stringent biocompatibility requirements. Chemical degradation and compression set failure occur when materials fail USP Class VI testing. This leads to compromised seals in medical devices and fluid transfer systems.

Material Science Analysis

Standard elastomers like NBR and EPDM fail USP Class VI due to insufficient chemical resistance and extractable impurities. Fluorocarbon elastomers (FKM) excel due to high fluorine content (66-70%). This creates a dense molecular structure resistant to chemical attack and minimizes extractables.

Technical Specs

• Material: FKM (Fluorocarbon Elastomer)
• Shore A Hardness: 70-90
• Tensile Strength: 15-20 MPa
• Elongation at Break: 150-250%
• Temperature Range: -20°C to +200°C
• Compression Set: ≤20% (22 hrs @ 200°C)

Technical Comparison

Parameter	FKM	NBR	EPDM
Chemical Resistance	Excellent	Good	Moderate
Temperature Range (°C)	-20 to +200	-40 to +120	-50 to +150
Compression Set (%)	≤20	≤40	≤30
USP Class VI Compliance	Yes	No	No

Standard Compliance

RubberQ’s IATF 16949-certified process ensures batch-to-batch consistency. Each lot undergoes ASTM D2000 material testing and ISO 3601 fluid resistance validation. PPAP documentation includes full traceability from raw materials to finished parts.

For custom material compound development or IATF 16949 documentation, consult RubberQ’s engineering department.