Personal wellness devices are usually made from platinum-cured liquid silicone rubber, and the certificates buyers request for these parts are often confused with each other. This guide sets out, in neutral manufacturing terms, which documents matter, what each one actually proves, and which claims to treat with caution.
The base document set
- Material data sheet. The compound's physical properties: hardness, tensile strength, elongation, tear strength, and compression set. This tells you how the part behaves, not whether it is safe.
- Platinum cure certification. A statement that the elastomer was cured with a platinum catalyst rather than a peroxide system, with the platinum residue level tested. Peroxide-cured silicone carries a characteristic odour and a higher level of extractables, which is why the cure system is specified separately.
- Food contact declarations. FDA and EU 10/2011 compliance for the compound, which is the baseline for skin-contact parts.
- Biocompatibility reports. Cytotoxicity, sensitisation and irritation testing to ISO 10993 scope, where the part will contact mucous membranes or broken skin.
- Lot certificates. Per-batch hardness and residual catalyst data, because a certified compound can still be moulded badly.
Cure system matters more than most buyers realise
Platinum-cured silicone and peroxide-cured silicone differ in ways that show up in the finished part. Platinum systems give a clearer part with lower extractables and no post-cure odour. Peroxide systems are cheaper but need a post-cure oven cycle to drive off decomposition by-products, and a part that skips that cycle will smell and can fail a cytotoxicity screen. When a quotation cites medical grade, ask which cure system and whether a post-cure is included in the cycle time.
Food grade is not medical grade
Food contact compliance is a migration test under food simulant conditions. Medical grade implies biocompatibility testing to ISO 10993 under the specific contact category and duration of the intended use. A food-grade silicone can fail a cytotoxicity screen, and a medical-grade compound can fail a migration test for fatty foods. They are different questions, and the certificate you need depends on the contact the part will actually see.
What to request, in order
- Material data sheet with hardness tolerance, since hardness drift is the most common quality complaint.
- Platinum cure certification with residue levels.
- Food contact declaration for the compound, with the specific regulation referenced.
- ISO 10993 reports to the contact category the part will see, from an accredited lab.
- Lot certificate for the production batch that will ship.
A note on claims
Medical grade, hypoallergenic and body safe are marketing terms without a fixed regulatory definition. The defensible position for a manufacturer is to state which test was run, by which lab, to which protocol, and let the buyer map that to their own claim strategy. Suppliers who offer a certificate without naming the protocol are usually offering a data sheet with a logo on it.
Related reading
Our platinum-cured LSR component programme supplies the full document set per lot, and the material guides compare platinum silicone against TPE on cost, feel and lifespan.
Related product categories
The materials and part types discussed above are grouped in our sourcing directory:
