Medical Rubber Product Testing

Applicable products: Suitable for various types of medical rubber products such as medical rubber gloves, medical rubber plugs, medical rubber catheters, medical sealing gaskets, rubber accessories for infusion/blood transfusion, surgical rubber products, medical rubber diaphragms, etc.

Applicable materials: Suitable for pharmaceutical grade rubber materials such as medical natural rubber, medical nitrile rubber, medical silicone rubber, medical chloroprene rubber, etc.

Applicable scenarios: Used for raw material access inspection, finished product factory inspection, medical device registration testing, biocompatibility verification, sterility and safety assessment, quality arbitration testing.

Appearance and size inspection: The appearance is free of bubbles, impurities, cracks, missing glue, burrs, discoloration, and oil stains; Detect dimensional tolerances, wall thickness uniformity, fitting accuracy, and surface cleanliness.
Physical and mechanical performance testing: Shore hardness, tensile strength, elongation at break, tear strength, compression set, rebound performance, bending resistance, and rubbing resistance testing.
Chemical performance testing: detection of reducing substances, acidity and alkalinity, heavy metal content, zinc content, volatile substances, extracts, non-volatile substances, and sulfide residues.
Biological safety performance testing: biological evaluation of cytotoxicity, skin sensitization, intradermal irritation, acute systemic toxicity, hemolysis test, local reactions after implantation, etc.
Hygiene and Aseptic Performance: Aseptic Testing, Bacterial Toxins, Microbial Limits, Ethylene Oxide Residue Testing.
Environmental resistance and performance evaluation: Evaluation of resistance to hot air aging, steam sterilization, radiation sterilization, drug-resistant liquids, body fluids, and cleaning and disinfection.
Special performance testing: evaluation of medical sealing performance, anti clogging, anti adhesion, impermeability, biological inertness, and non allergenicity.