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What approvals do I need?
This depends on many things, but the following questions should always be addressed:
Does the target market demand specific approvals?
Does your insurance company demand specific approvals?
Does it need to be implantable for more than 29 days?
Does it need to be resistant to certain chemicals?
Must it be able to withstand sterilisation methods (e.g. autoclaving)?
Should it be resistant to weather/ozone/UV?
What physical characteristics are required?
Does it need to be pigmented (i.e. will it be coloured or transparent?
Are there cost constraints?
What is the proposed manufacturing technique?
About Medical Silicone
Material Approvals
The area of material approvals can be intimidating for some and confusing for most!
Here, we have tried to simplify this necessary topic by providing a common sense interpretation of the more frequently demanded material approvals.
Of course, we always recommend that you look at the original source of these approvals when assessing suitable materials for your own product.
The following references may be helpful:
ISO 10993 see the main ISO (International Organization for Standardization) website
USP Class VI see the United States Pharmacopeia (USP) website
EP 3.1.9 see the EuropeanPharmacopeia (EP) website
FDA Food Grade (21 CFR 177.2600) see the FDA website