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what kinds of medical devices need test endotoxins?
Medical Devices Requiring Endotoxin Testing: Blood-Contacting, Implantable, Dialysis, Ophthalmic and Sterile Medical Devices

 Bacterial Endotoxin Testing (BET) is performed to ensure that medical devices comply with established endotoxin limits, thereby reducing the risk of pyrogenic reactions   and protecting patient safety.


 Blood-Contacting Medical Devices

  • Hemodialyzers

  • Blood Tubing Sets

  • IV Catheters

  • Central Venous Catheters

  • Blood Filters

  • Blood Transfusion Sets

  • Extracorporeal Circuits

  • Vascular Grafts

  • Coronary Balloon Catheters

  • Vascular Stents

 Implantable Medical Devices

  • Orthopedic Implants

  • Dental Implants

  • Spinal Implants

  • Prosthetic Heart Valves

  • Cardiovascular Implants

  • Surgical Meshes

 Ophthalmic Medical Devices

  • Intraocular Lenses (IOLs)

  • Ophthalmic Viscoelastic Devices (OVDs)

  • Ophthalmic Surgical Instruments

 Dialysis Devices

  • Hemodialyzers

  • Peritoneal Dialysis Devices

  • Hemodialysis Blood Tubing Sets

 Drug Delivery Devices

  • Prefilled Syringes

  • Auto-injectors

  • Infusion Sets

  • Infusion Pump Accessories

  • Sterile Drug Filters

 Sterile Disposable Medical Devices

  • Syringes

  • Hypodermic Needles

  • IV Connectors

  • Needle-free Connectors

  • Surgical Drainage Tubes

  • Endotracheal Tubes


 Applications of Bacterial Endotoxins Testing (BET) for Medical Devices

  • Blood-contacting medical devices

  • Implantable medical devices

  • Hemodialysis and peritoneal dialysis devices

  • Cardiovascular devices

  • Ophthalmic medical devices

  • Orthopedic implants

  • Drug delivery systems

  • Sterile disposable medical devices

  • Surgical instruments and accessories

  • Medical devices requiring pyrogen/endotoxin control under USP <85>, USP <161>, ISO 10993, and AAMI ST72