Medical Material Approvals | LSR HCR Platinum or Peroxide
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?
- 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
We work closely with our medical and pharmaceutical customers through the product development stages from product realisation to full production.
Contact our medical team to discuss your requirements:
Call us on +44 (0)1544 312660
Email us on firstname.lastname@example.org us your requirements