Episoder
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Everything you need to know about biocompatibility - in one podcast.
From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group.
๐๐ถ๐ผ๐ฐ๐ผ๐บ๐ฝ ๐ญ๐ฌ๐ญ: ๐๐๐ป๐ฑ๐ฎ๐บ๐ฒ๐ป๐๐ฎ๐น๐ ๐ณ๐ผ๐ฟ ๐ ๐ฒ๐ฑ๐ง๐ฒ๐ฐ๐ต ๐ฃ๐ฟ๐ผ๐ณ๐ฒ๐๐๐ถ๐ผ๐ป๐ฎ๐น๐
By understanding biocompatibility and following best practices, manufacturers can ensure the safety and efficacy of their medical devices:
- Biocompatibility involves material selection, device design, testing, and risk management.
- Direct and indirect contact with the body are key considerations.
- Regulatory requirements and risk assessment are essential.
- Material selection can be challenging due to potential adverse reactions.
- Device design must minimize the risk of complications.
- Testing limitations and regulatory compliance can be complex.
๐๐ฎ๐๐ถ๐ฐ๐ ๐ผ๐ณ ๐๐ถ๐ผ๐ฐ๐ผ๐บ๐ฝ๐ฎ๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐
What is assessed, when is it assessed
๐๐ฎ๐๐ฒ ๐ฆ๐๐๐ฑ๐ #๐ญ
- IEC standard 60601-1
- ISO 14971
- ISO 10993
๐๐ฎ๐๐ฒ ๐ฆ๐๐๐ฑ๐ #๐ฎ
- Testing connector cables for leachables
๐๐ฎ๐๐ฒ ๐ฆ๐๐๐ฑ๐ #๐ฏ
- Intended Use vs Depicted Use
- Costs and documentation changes arising from failed biocompatibility testing
๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ถ๐ฐ๐ฒ ๐๐ต๐ฎ๐ป๐ด๐ฒ๐ ๐ฅ๐ฒ๐พ๐๐ถ๐ฟ๐ถ๐ป๐ด ๐๐ถ๐ผ๐ฐ๐ผ๐บ๐ฝ๐ฎ๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐ ๐ง๐ฒ๐๐๐ถ๐ป๐ด
๐๐ฎ๐๐ฒ ๐ฆ๐๐๐ฑ๐ #4
- Heat changes chemistry, which means biocompatibility testing
๐๐ถ๐ผ๐ฐ๐ผ๐บ๐ฝ๐ฎ๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐ ๐ง๐ฒ๐๐๐ถ๐ป๐ด ๐๐ ๐ฒ๐บ๐ฝ๐๐ถ๐ผ๐ป๐ ๐ฎ๐ป๐ฑ ๐ช๐ต๐ฒ๐ป ๐ง๐ต๐ฒ๐ ๐๐ฝ๐ฝ๐น๐
๐ ๐ฎ๐ป๐ฎ๐ด๐ถ๐ป๐ด ๐๐ถ๐ผ๐ฐ๐ผ๐บ๐ฝ๐ฎ๐๐ถ๐ฏ๐ถ๐น๐ถ๐๐ ๐ฅ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ ๐ฏ๐ ๐๐ผ๐๐ป๐๐ฟ๐
- Animal testing
- Biocompatibility testing labs
- ASCA program
๐๐ผ๐ป๐๐ฎ๐ฐ๐ ๐๐๐ฟ๐ฎ๐๐ถ๐ผ๐ป -
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27:15 - Nika Mendelev explains whether you really need to choose one or the other.
32:10 - the Q+A session begins.
Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY -
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