Silicone sealant for medical device

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SUMMARY

The discussion centers on the suitability of silicone sealants for medical applications, specifically for PVC tubing and dialysate at body temperature. Participants highlight the need for biocompatibility and mention two types of silicone sealants: acetoxy and elastomer. Concerns are raised about the lack of certification for medical standards for commonly available silicone sealants. It is emphasized that consulting with manufacturers is crucial for obtaining accurate information regarding compliance with medical regulations.

PREREQUISITES
  • Understanding of biocompatibility standards for medical materials
  • Knowledge of silicone sealant types, specifically acetoxy and elastomer
  • Familiarity with medical device regulations and certifications
  • Basic knowledge of PVC tubing applications in medical settings
NEXT STEPS
  • Research biocompatibility testing standards for silicone sealants in medical applications
  • Investigate the differences between acetoxy and elastomer silicone sealants
  • Learn about regulatory requirements for materials used in medical devices
  • Contact manufacturers of silicone sealants for detailed product specifications and certifications
USEFUL FOR

Medical device engineers, product developers in the healthcare sector, and quality assurance professionals seeking to understand material compliance in medical applications.

asherraph
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i want to ask...is it any type of silicone sealant is suitable for medical application??

i need to find the sealant that are biocompatibility for pvc tubing and dialysate with body temperature.

how about acetoxy and elastomer is it suitable??
 
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I don't know the answer to your question but I ask you this: do you have reason to believe that regular old hardware store silicone sealant will not be suitable for your application?
 
asherraph said:
i want to ask...is it any type of silicone sealant is suitable for medical application??

i need to find the sealant that are biocompatibility for pvc tubing and dialysate with body temperature.

how about acetoxy and elastomer is it suitable??
Why in the world are you asking this question on the Internet? If you are working with medical devices that interface directly with bodily fluids and patients, surely there are regulations for what kinds of materials can be used. Doesn't your company have people who know this information?
 
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phinds said:
I don't know the answer to your question but I ask you this: do you have reason to believe that regular old hardware store silicone sealant will not be suitable for your application?
i do believe regular silicone is suitable for medical application and i found the silicone sealant but there is no certificated or verification to medical standard testing.

there are two type silicone sealant that i found which acetoxy and elastomer.
 
berkeman said:
Why in the world are you asking this question on the Internet? If you are working with medical devices that interface directly with bodily fluids and patients, surely there are regulations for what kinds of materials can be used. Doesn't your company have people who know this information?

i m still new to this material and chemical. i do more work on electronics and 3d modelling part. my boss just ask me to find out the silicone sealant that have verification on medical standard even we know that silicone is biocompatiblity.

i do found acetoxy and elastomer and i know both are silicone. what make different between both of this??
 
asherraph said:
i m still new to this material and chemical. i do more work on electronics and 3d modelling part. my boss just ask me to find out the silicone sealant that have verification on medical standard even we know that silicone is biocompatiblity.

i do found acetoxy and elastomer and i know both are silicone. what make different between both of this??
I suggest you call the manufacturer's representative for the companies that make these sealants. They should be able to give you knowledgeable advice. Thread is closed.
 
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