Medical Material Approvals | LSR HCR Platinum or Peroxide

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?

• 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 also 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