What surface finishes are compliant with ISO 10993 or FDA guidelines?
What Surface Finishes Are Compliant with ISO 10993 or FDA Guidelines?
Overview of ISO 10993 and FDA Requirements for Surface Finishes
When manufacturing aluminum die cast components for medical or hygiene-critical applications, surface finishes must comply with ISO 10993 biocompatibility standards and, where applicable, FDA 21 CFR guidelines. These standards assess a finish’s cytotoxicity, sensitization, and chemical stability when in contact with human tissue or sterilization environments. Neway provides surface finishing solutions that meet these criteria for both Class I and Class II medical devices.
ISO 10993-Compliant Surface Finishes for Aluminum
The following surface finishes, when properly controlled, are suitable for use on aluminum die cast parts such as those made from A360 or ADC12:
Anodizing
Anodizing creates a non-reactive oxide layer, free from heavy metals or toxic residues. Type II and Type III anodizing, when sealed and properly rinsed, are compliant with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation). This finish is widely used for surgical enclosures, housings, and medical instrument casings.
Powder Coating
Powder coating is compliant when using FDA-approved resins such as polyester or epoxy-polyester hybrids. These coatings offer chemical resistance and are non-toxic upon curing. Powder-coated surfaces are ideal for devices requiring high durability and routine cleaning with disinfectants.
Electropolishing (Stainless or Aluminum)
Though more common in stainless steel applications, electropolished aluminum surfaces (post-anodizing) meet ISO 10993 standards by eliminating surface impurities and improving corrosion resistance. Neway offers post-machining options to prepare cast parts for electropolishing or hybrid finishing.
Medical-Grade Painting
Painting using FDA-compliant coatings can be applied to die cast aluminum parts when powder coating is not feasible. Low-VOC, biocompatible formulations are used in devices intended for indirect patient contact.
Surface Finish Restrictions to Avoid
Finishes that may compromise compliance include:
Unsealed anodizing or poor rinse quality (may cause cytotoxicity)
Paints containing volatile organic compounds (VOCs) or non-FDA pigments
Plating with nickel or chromium without proper encapsulation
Neway uses validated finishing protocols and certified material suppliers to ensure coatings meet both performance and regulatory standards.
Compliant Surface Finishing from Neway
Neway delivers ISO- and FDA-compliant finishing solutions as part of our aluminum die casting and post-processing services. We offer:
Sealed anodizing for medical housing applications
Biocompatible powder coating for lab and diagnostic equipment
FDA-grade painting for high-visibility enclosures
Full inspection and documentation for traceable compliance
