Dear friends,
Do you know whether it's allowed to use the molding release ( molding relief agent ) for injection plastics parts for Medical device?
Could we use the food or Medical grade molding release for these parts? our parts are for Non implantation medical products, it's used for dentist in patient's mouth.
I need your help urgently.
Thanks a lot.
Best regards,
Andy
Hi,
Ignoring for a moment your relations with your clients,
- A substantiated need to add separate mould release agents (not inherent in the base resin) is typically an indication of either poor part design (including base resin grade selection), poor tool design, poor moulding parameters setting(s) and/or control, poor resin quality or lack of sufficient control over it, or any combination of the above.
- Material(s) acceptability for medical devices applications is typically determined not through individual ingredients but through the final result - in as-used state - including the effects of all relevant manufacturing processes (including packaging and sterilisation, as applicable). When a medical device is to be qualified as biocompatible the effects of storage, handling, environmental factors, use factors (for multi-use devices) etc., throughout the device's shelf and use life, should preferably be considered and accounted for.
- Specific biocompatibility requirements and testing recommendations are typically determined by the device's / part's nature of contact with different tissue types, and the (accumulated) duration of contact. ISO 10993-1 is a good starting point in that regard, for most of the leading medical devices regulatory systems (e.g. the USA, the EC etc.).
Cheers,
Ronen.