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Laminaria Stick (Cervical Dilator) - Biocompatibility Test required?


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Dear Sir/Madam,

Laminaria is a sea-grown plant containing no synthetic materials after harvesting, the plant is hydrated. The laminaria is a dried stalk of the ocean kelp (Algae) which has been rounded on the surface as well as the end rounded to create a smooth laminaria stick.

Laminaria stick ( Cervical Dilator) does it required Bio-compatibility test?

Please help ...Thank you.
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Re: Laminaria Stick ( Cervical Dilator) - Biocompatibility Test required ?


For medical devices in direct or indirect patient contact, ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, applies.

As indicated by the title of this standard, you need to perform a biological evaluation, and based on the biological risks you have identified you may need to perform testing. Or, you may have enough objective evidence at hand to justify omission of all or some testing - it depends.


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