Medical PEEK & Technical Plastics Precision Machining
CNC machining specialist for implantable PEEK, PEEK-CF, PTFE and POM-C. Biocompatible polymer parts manufactured under ISO 13485 procedures — from prototype to series production.
Tolerance
±0.01 mm
Surface finish
Ra < 0.4 µm
Certification
ISO 13485
PEEK Grades — Standard, Medical, Implantable & CF
Selecting the correct PEEK grade is critical: regulatory requirements, biocompatibility certifications and machining parameters differ significantly between grades. Our technical team guides you from specification to delivery.
Standard PEEK
Industrial grade — bearings, gears, high-temperature insulating parts up to 250°C continuous.
Medical PEEK
ISO 10993 biocompatibility-tested — surgical instruments, housings, guides. Non-implantable.
Implantable PEEK (PEEK-OPTIMA™)
Authorised for permanent bone contact per ASTM F2026 and ISO 10993. MRI-compatible. Ra < 0.4 µm required.
PEEK-CF
Carbon-fibre reinforced PEEK — elastic modulus ~18 GPa (similar to cortical bone). Spinal cages, structural implants.
Technical Polymers — Properties & Applications
From high-performance PEEK to cost-effective POM-C, our machine park handles the full range of engineering polymers with the precision your application demands.
PEEK
Medical ref.Polyetheretherketone
Key properties
- ›Biocompatible ISO 10993 (medical grade)
- ›Tg 143°C — continuous thermal resistance
- ›Radiolucent (MRI/CT-scan compatible)
- ›Total chemical resistance to acids/bases
- ›Elastic modulus ~3.6 GPa
- ›PEEK-CF: carbon-fibre reinforced
Typical applications
- ›Spinal implants / intervertebral cages
- ›Surgical guides & implantable housings
- ›Endoscopic instruments
- ›High-temp chemical pump components
POM / Delrin®
Polyoxymethylene (Acetal)
Key properties
- ›Best machinability of thermoplastics
- ›Low friction coefficient (0.20–0.35)
- ›Exceptional dimensional stability
- ›POM-C complies FDA 21 CFR — food contact
Typical applications
- ›Precision gears and pinions
- ›Guide bushings and dry bearings
- ›Industrial connectors
- ›Food and pharmaceutical parts
PTFE
Polytetrafluoroethylene (Teflon®)
Key properties
- ›Friction coefficient 0.04 (lowest)
- ›Absolute chemical inertness
- ›Temperature range: −200°C / +260°C
- ›FDA 21 CFR approved
Typical applications
- ›Seals, valve seats, sealing rings
- ›Self-lubricating bearings
- ›High-voltage insulators
- ›Chemical process fittings
PA 66-GF30
Polyamide 6.6 glass-fibre 30%
Key properties
- ›Improved mechanical strength (GF30)
- ›Good dynamic fatigue resistance
- ›Excellent strength-to-weight ratio
Typical applications
- ›Guide rollers and conveyor wheels
- ›High-load dry bearings
- ›Lightweight structural parts
PVDF
Polyvinylidene fluoride
Key properties
- ›Complies FDA 21 CFR & EU 10/2011
- ›UV and gamma radiation resistance
- ›Inert to concentrated acids/bases
Typical applications
- ›Pharmaceutical and food process parts
- ›Ultra-pure water piping
- ›Pressure and flow sensors
Machining Process — Thermal Management & ISO 13485 Traceability
Machining biocompatible polymers requires strict process discipline that goes beyond standard metal turning. Contamination risk, dimensional stability and surface finish traceability are managed systematically from raw material receipt to final inspection.
Every implantable PEEK part is accompanied by a full dimensional inspection report, the original PEEK-OPTIMA™ material certificate (lot number, CoC), and Ra measurement records — all archived for a minimum of 10 years under our ISO 13485 document control procedure.
Dedicated tooling — no cross-contamination
Separate carbide tooling sets reserved exclusively for medical PEEK and technical plastics. No coated tools for implantable grades (coating particles = contamination risk). Tool traceability maintained per ISO 13485.
Thermal management — dry or air-blast machining
PEEK generates localised heat at the cutting edge. Excessive coolant can penetrate micro-pores and alter surface chemistry. We use dry machining or compressed air evacuation for implantable grades — validated by Ra measurement after each batch.
Surface finish — Ra < 0.4 µm systematic measurement
Ra is measured on every implantable PEEK part using a contact profilometer (Mitutoyo SJ-210). Ra < 0.4 µm is a hard requirement for biocompatibility — values recorded in the part inspection report.
CMM dimensional inspection — ±0.01 mm verified
All critical dimensions inspected on a Zeiss CMM. Measurement uncertainty budget documented. For implantable parts, 100% inspection on key characteristics — no statistical sampling. Reports delivered with each shipment.
ISO 13485 traceability — material to delivery
Lot-by-lot traceability from PEEK-OPTIMA™ bar certificate through machining work order to final inspection. Non-conforming parts quarantined under 8D corrective action procedure. 10-year archive minimum.
Medical PEEK & Technical Plastics — Frequently Asked Questions
Medical PEEK Machining Quote — 24h Response
Send your STEP file or 2D drawing. Our technical team assesses feasibility and responds within one business day. NDA available. ISO 13485 procedures guaranteed.