EndoLab - Implant Testing Services Implant Testing

Instruments
 

Corrosion of Surgical Instruments - ASTM F1089Corrosion of Surgical Instruments - ASTM F1089 Pen-injectors and needle-based injection systemsPen-injectors and needle-based injection systems Enternal feeding devices - ASTM F2528Enternal feeding devices - ASTM F2528 Standard test method for penetration testing of needles used in surgical sutures - ...Standard test method for penetration testing of needles used in surgical sutures - ASTM F3014 Intracranial pressure monitoring devicesIntracranial pressure monitoring devices Dentistry - Implants - Clinical performance of hand torque instruments - ISO 11953Dentistry - Implants - Clinical performance of hand torque instruments - ISO 11953 Glass Cylinders for Pen Injectors - ISO 13926-1Glass Cylinders for Pen Injectors - ISO 13926-1 Surgical and Dental Hand Instruments – Determination of Resistance against Autoclaving, ...Surgical and Dental Hand Instruments – Determination of Resistance against Autoclaving, Corrosion and Thermal Exposure - ISO 13402 Instruments for Non-active Surgical Implants - ISO 16061Instruments for Non-active Surgical Implants - ISO 16061

Instruments for Non-active Surgical Implants - ISO 16061

Normative References  



ISO 16061: Instruments for use in association with non-active surgical implants — General requirements

DIN EN ISO 16061: Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen

This standard addresses the general requirements for non-active surgical instruments. For special requirements for groups of instruments or individual instruments, reference is made to so-called level 2 and level 3 standards. Design attributes and materials are listed to serve as a basis for risk analysis.
EndoLab will support you in the pre-clinical evaluation. We have a large number of test protocols to prove the durable function of your instrument in clinical practice.  


Implant Testing - Instruments for Non-active Surgical Implants - ISO 16061 Instruments for Non-active Surgical Implants - ISO 16061


Implant groups

Hip implants Knee implants Spinal implants Shoulder implants Finger implants Osteosynthesis Instruments Ankle implants Vascular implants Material testing Dental implants Particle analysis Elbow implants Wrist implants Exoprosthesis Consumables
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