ISO 10993: Testing for Cytotoxicity and Sensitization in Rubber Parts.

ISO 10993: Testing for Cytotoxicity and Sensitization in Rubber Parts

Problem Statement

Rubber components in medical devices often fail biocompatibility tests due to cytotoxic leachables or sensitizing agents. These failures occur when improper curing agents, fillers, or plasticizers migrate from the polymer matrix.

Material Science Analysis

Standard EPDM compounds exhibit cytotoxicity due to zinc stearate migration. Fluorocarbon elastomers (FKM) outperform due to their fluorine-rich backbone, which resists chemical leaching. HNBR compounds, when formulated with peroxide curing systems, eliminate cytotoxic byproducts.

Technical Specs

• Material: FKM (Fluorocarbon Elastomer)
• Shore A Hardness: 70 ± 5
• Tensile Strength: 15 MPa
• Elongation at Break: 200%
• Temperature Range: -20°C to 200°C
• Compression Set: 15% (22 hrs @ 200°C)
• Chemical Resistance: Resistant to oils, fuels, and sterilants (e.g., ethylene oxide).

Technical Comparison

Material	Shore A Hardness	Tensile Strength (MPa)	Elongation at Break (%)	Temperature Range (°C)	Compression Set (%)
FKM	70 ± 5	15	200	-20 to 200	15
EPDM	60 ± 5	10	300	-40 to 150	25
HNBR	75 ± 5	18	250	-30 to 180	20

Standard Compliance

RubberQ adheres to IATF 16949 protocols for batch traceability and PPAP documentation. Each compound undergoes ASTM D2000 material callouts and ISO 3601 fluid resistance testing. Cytotoxicity and sensitization tests comply with ISO 10993-5 and ISO 10993-10 standards.

CTA

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