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What is ISO 10993 biocompatibility testing?

The ISO 10993-1: 2018 standard defines biocompatibility as the “ability of a medical device or material to perform with an appropriate host response in a specific application”. So choosing the correct lubricant for your medical device is crucial in end stage manufacturing and to the patient the device was used on. The purpose of performing bio compatibility testing on any medical device is to determine if the nature of the device is fit for human use and will not deliver any potentially harmful unwanted physiological effects to the patient. Understanding how the device operates along with several other factors that include: device materials used, manufacturing techniques and sterilization techniques also play a vital role in keeping the device within bio compatibility standards.

 

TriboSys Greases & Oils meet biocompatibility under ISO 10993 standards​

Miller-Stephenson’s TriboSys medical oils and greases are high performance, fluorinated lubricants that greatly minimize mechanical wear and have exceptional thermal stability under all hospital sterilization techniques with zero migration. MS-31XXMD Oils and MS-32XXMD Greases are non-nutrient, non hazardous, oxygen safe and meet bio compatibility under ISO 10993 standards, making TriboSys lubricants a top choice for all medical device manufactures and end user medical applications. All TriboSys oil viscosities are clear, PFPE (perfluoropolyether) based and all TriboSys grease viscosities utlize PFPE base oil that is thickened with PTFE to form a white creamy grease. 

Passed ISO 10993 Tests:

  • Dermal Sensitization Test
  • Intracutaneous Test 
  • Cytotoxicity Test
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