Standards
The international standards that define our work.
A consolidated reference to the ASTM, ISO, and GB standards our products and processes are designed to comply with. Use the table of contents to navigate by area.
| Standard | Title | Scope |
|---|---|---|
| ASTM F136 | Wrought Ti-6Al-4V ELI for surgical implants | Material |
| ASTM F382 | Metallic bone plates — mechanical test methods | Mechanical |
| ASTM F2026 | PEEK polymers for surgical implant applications | Reference (PEEK) |
| ASTM F3301 | AM of metallic medical implants — process & material | AM |
| ASTM F3434 | Guide for AM of metallic medical implants | AM characterisation |
| ASTM F86 | Surface passivation of metallic surgical implants | Surface |
| ASTM E8 | Tension testing of metallic materials | Mechanical |
| ASTM B214 | Sieve analysis of metal powders | Powder |
| ISO 5832-3 | Titanium alloys for surgical implants — Ti-6Al-4V | Material |
| ISO 9585 | Bending & torsion fatigue of bone plates | Fatigue |
| ISO 14801 | Fatigue testing of dental implants | Fatigue (reference) |
| Standard | Title | Scope |
|---|---|---|
| ISO 10993-1 to -22 | Biological evaluation of medical devices | Biological |
| ISO 19227 | Cleaning of orthopaedic implants | Cleaning |
| ISO 11137 | Sterilisation — gamma | Sterilisation |
| ISO 11135 | Sterilisation — EO | Sterilisation |
| ISO 11607-1/-2 | Packaging | Packaging |
| ISO 13485 | QMS for medical devices | QMS |
| ISO 14971 | Risk management for medical devices | Risk |
| ISO 10360 | CMM inspection | Dimensional |
| ISO 13322-1 | Particle size analysis — laser diffraction | Powder |
| ISO 4287/4288 | Surface roughness | Surface |
| GB/T 13810 | Wrought Ti-6Al-4V for surgical implants (China) | Material — China |
Coding Reference
How our products are coded around the world.
| Coding system | Code | Note |
|---|---|---|
| GMDN | 61439 / 66699 (legacy) | Transitioning to EMDN in EU |
| EMDN | P04029901 (custom-made CMF implants) | Mandatory in EU from 2026-05-26 |
| CND (Italy) | Y030399 (Impianti cranici specifici paziente) | Italian national classification |
| BASIC UDI-DI | CRANIO-PSI-3D-PEKK-FAM (proposed) | Per implant family, per MDR |
| NPC (UK NHS) | ABA919 (custom-made cranial implants) | NHS National Product Catalogue |
| ICD-10-PCS | 0NR00JZ (replacement of skull with synthetic substitute, open) | US inpatient procedure code |
| CPT (US) | 21184 (reconstruction of supraorbital, frontal, and/or temporal) | US professional fee |
| OPS-301 (DE) | 5-025.2 / 5-025.3 (cranioplasty with autologous / alloplastic material) | German procedure code |
| CCAM (FR) | (cranioplasty procedure codes) | French procedure code |
| OPCS-4 (UK) | V03.1 / V03.2 (cranioplasty) | UK procedure code |