Niche · Niche Process
Medical Grade Molding
USP Class VI / ISO 10993 biocompatible materials + controlled injection molding environment under ISO 13485, covering surgical instruments, diagnostic devices, implant prototypes, and disposable devices.
Medical Grade vs. Industrial Grade Molding
Ordinary injection molding factories can mold parts, but medical grade molding requires the entire process chain to be “clean”: raw materials with USP Class VI / ISO 10993 certification / batch traceable to production lot; molds made of medical-grade S136 polished steel; workshop cleanliness level ISO 8 (100,000 class) or above; operators wearing cleanroom suits and trained in GMP procedures; each batch with DHR records for traceability.
Common Medical Plastics
| Material | Certification | Sterilization Resistance | Typical Applications |
|---|---|---|---|
| Medical PC (e.g., Makrolon Rx) | USP VI / ISO 10993-5 | Gamma / EtO / Autoclave | Transparent parts, housings, containers |
| Medical PEEK | USP VI / ISO 10993-1~6 | Repeated 134°C steam | Implant prototypes, endoscopes |
| Medical PP | USP VI | Gamma / EtO | Syringes, reagent bottles |
| Medical PE / PETG | USP VI / FDA | Gamma preferred | Disposable devices |
| Medical POM | USP VI | Limited | Low-friction transmission parts |
| Medical PMMA | USP VI | Limited (avoid solvents) | Transparent housings, inspection windows |
| Liquid Silicone Rubber LSR (Medical) | USP VI / ISO 10993 | All methods | Seals, catheters, masks |
| TPE / TPU Medical Grade | USP VI | EtO preferred | Soft overmolding, catheters |
Workshop & Process Requirements
- Cleanroom: ISO 8 (100,000 class) standard, ISO 7 (10,000 class) customizable for critical stations
- Raw Material Control: CoA + CoC certificates archived per batch, limited usage period after opening
- Mold Material: S136H (corrosion-resistant mirror finish) / NAK80, chromium-containing steel prohibited
- Mold Release Agent: Oil-based release agents prohibited; use medical-grade silicone spray or mechanical ejection
- Packaging: Multi-layer clean bags + vacuum + dust-proof box to prevent secondary contamination during transport
- Documentation: DHR (Device History Record) batch traceability chain, retained for at least 7 years
Compliance Support
- ISO 13485:2016 system
- FDA 21 CFR Part 820 process documentation support
- EU MDR manufacturer technical file cooperation
- NMPA (China) registration documentation support
- Customer audit support (appointment 2 weeks in advance)