Why you can't just pay lip service to "medical grade silicone"?
Medical applications are concerned with more than just the material itself:
- Source and consistency of ingredients
- Production process control
- Batch traceability
- Cleaning & Packaging
- Applicable regulations and test reports
This article summarizes the common requirements for medical grade silicone products in a way that can be applied to both procurement and engineering.
Common Application Scenarios
- Seals and dustproof parts for medical equipment
- Medical consumable accessories (depending on the specific product category)
- Silicone parts for short-term skin contact
Documents/information you may be asked to provide (in order of commonness)
1) Material related
- Material specifications (basic properties such as hardness, tensile, tear, etc.)
- Material Lot Information and Incoming Material Records
- Material Compliance Statement (based on target market and use)
2) Production and quality related
- Critical process control points (temperature, time, vulcanization conditions, etc.)
- First Article Confirmation and Inspection Record
- Shipment inspection criteria (appearance/size/function)
- Defective product handling and corrective action records (if applicable)
3) Traceability and consistency
- Batch traceability: raw material batch → production batch → shipment batch
- Consistency of labeling and packaging information
For healthcare customers, "traceability + reproducibility" is often more important than "descriptive performance".
Common test directions (select as needed for your project)
Compliance requirements vary greatly from country to country and from product category to product category, so here is only a list of "common test directions", the final customer/regulatory requirements shall prevail.
- Size & Appearance: Critical dimensions, tolerances, burrs, foreign matter
- physical property: Hardness, Tensile, Tear, Resilience
- Aging and Durability: Heat aging, permanent deformation in compression
- Cleaning Related: Cleanliness, particle/foreign matter control (on demand)
- Medium related: Resistant to disinfectant/alcohol wipes (on demand)
Production control recommendations (making requirements more "enforceable")
- Marking of "critical dimensions (CTQ)" on drawings and agreement on inspection methods
- Specify the permissible parting line, burr height, and appearance grade of the surface
- Agreed packaging: inner bag, outer box, labeling information
- Small batch verification first: dimensional consistency + assembly verification + aging comparison
FAQ
Q: What certifications must be done for medical grade?
It depends on the product category and target market. It is recommended that the customer confirms the applicable standards and the list of required documents, and then extrapolates what tests and records the factory needs to prepare.
Q: Is it enough if the material is compliant?
Often not enough. Process control, cleaning and traceability are equally critical.