In Scope
Implant-Grade Subtractive Machining
3-axis, 4-axis, 5-axis milling, turning, mill-turn, and micro-machining of wrought Ti-6Al-4V ELI bar, billet, and forging stock for orthopedic, spinal, dental, trauma, and surgical-instrument components.
Boze Titanium Manufacturing Center | Grade 23 Ti-6Al-4V ELI | ASTM F136
Grade 23 Titanium CNC Machining Services — Ti-6Al-4V ELI (UNS R56407)
Precision Ti-6Al-4V ELI (Grade 23) components for orthopedic, spinal, dental, and surgical-instrument applications. ASTM F136 / ISO 5832-3 controlled process with ELI interstitial verification, ASTM F86 surface preparation, and sterilization-compatible finishing. ±0.005 mm tolerance target on validated micro-features.
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±0.005mm Tolerance
ASTM F136 Standard
1 piece MOQ
5–7 d Prototype
Ti-6Al-4V ELI UNS R56407 ASTM F136 ISO 5832-3 ASTM F86
AS9100D
Aerospace Quality Management System
ISO 9001:2015
Certified Quality Management System
Medical Device Quality Standard
MTR Traceability
Material Test Reports with Every Shipment
Scope & Limits
What This Page Covers — and What It Does Not
We machine Ti-6Al-4V ELI (Grade 23) to customer-defined drawings and purchase specifications, with material standards, condition, inspection requirements, and acceptance criteria confirmed during RFQ review. The limits below are not caveats — they are the regulatory and process boundaries you should validate before releasing a drawing.
In Scope
ASTM F136 / ISO 5832-3 Traceability
ELI interstitial limits, lot / heat identification, MTR per EN 10204 3.1, dimensional inspection records, and the agreed certificates of conformance reviewed against the order documentation.
In Scope
Sterilization-Compatible Finishing
ASTM F86 surface preparation, electropolishing, Type II / Type III anodizing for color coding, controlled cleaning, and packaging per the agreed clean-room class.
Out of Scope
Finished-Device Regulatory Clearance
Material conformity per ASTM F136 / ISO 5832-3 does not establish finished-device compliance. FDA / CE / NMPA clearance, sterilization validation, and finished-device biocompatibility testing remain the customer regulatory responsibility.
Out of Scope
Universal Tolerance Guarantees
±0.005 mm and micro-feature fidelity are project-specific precision targets. Final tolerance is confirmed after CAD, drawing, material condition, feature geometry, volume, and inspection-method review.
Out of Scope
Sterilization Validation
We supply components suitable for the agreed sterilization route, but we do not perform or validate finished-device sterilization cycles. Sterilization qualification remains the customer regulatory responsibility.
Engineering Compliance
Medical-Grade Material Compliance Starts with the Correct Specification
For orthopedic, spinal, dental, and surgical-instrument components, the material specification is the first control point and the foundation for finished-device compliance. The manufacturing process must preserve drawing requirements, ELI material identity, dimensional conformity, and lot-level documentation.
| Standard / Specification | Material or Quality Scope | Application in Procurement |
|---|---|---|
| ASTM F136 | Wrought Ti-6Al-4V ELI alloy for surgical implant applications | Confirm ELI material designation, interstitial limits, and applicable requirements for implant components. |
| ISO 5832-3 | Wrought Ti-6Al-4V alloy for surgical implants | Verify the specified material grade and applicable product requirements for implant-related components. |
| ASTM B348 | Titanium and titanium alloy bars and billets (general) | Verify grade, condition, dimensions, and material certification for non-implant Ti-6Al-4V ELI bar / billet stock. |
| AMS 4930 | Aerospace Ti-6Al-4V ELI bar, wire, and forging stock | Confirm specification applicability when aerospace-grade ELI stock is required for medical or hybrid programs. |
| ASTM F86 | Standard practice for surface preparation and marking of metallic surgical implants | Reference for the agreed passivation and surface preparation step on finished implant components. |
| AS9100D | Aerospace quality management system | Applicable when the manufacturing facility holds the relevant certification and the program has aerospace overlap. |
| ISO 9001 | Quality management system | Applicable when the manufacturing facility holds the relevant certification. |
Material Documentation: MTR supplied with each shipment covered by the agreed traceability requirements.
Material certificates, ELI interstitial verification, heat / lot identification, and purchase specification requirements are reviewed against the order documentation. Customer-supplied medical-grade material is accepted by prior agreement subject to incoming inspection and identification.
Technical Capabilities
Three Critical Controls for Medical-Grade Ti-6Al-4V ELI Machining
01
Biocompatibility and Surface Integrity
Engineering Challenge
Implant components must not introduce contaminants, foreign material, or surface conditions that compromise biological safety. Cross-contamination from non-medical work, residual machining fluid, embedded abrasive, or uncontrolled surface chemistry can affect osseointegration, fatigue performance, and regulatory acceptance. ELI chemistry alone does not establish finished-implant biocompatibility.
Our Machining Approach
We segregate medical-grade work where the order scope requires it, use cutting fluids and cleaning agents compatible with the agreed surface-preparation route, and verify that no cross-contamination from prior work is introduced. Material identity is preserved through incoming inspection, in-process marking, and segregated tool / workholding. Surface preparation per ASTM F86 (pickling / passivation) and, where specified, electropolishing are scheduled as part of the agreed process route.
Engineering Outcome
Implant-grade surface integrity suitable for downstream passivation and sterilization; preserved ELI material chemistry at the machined surface; documented material identity and lot traceability through to the shipping record. Finished-device biocompatibility remains subject to the customer regulatory validation and sterilization qualification.
02
Thin-Wall, Micro-Feature, and Thread Precision
Engineering Challenge
Implant geometries often combine thin walls (spinal cage struts, acetabular shell features), micro-features (bone-screw thread forms, micro-pores for bone apposition), and small lot sizes. Springback, tool deflection, and chip evacuation are amplified at these scales. Standard machining approaches optimised for thicker aerospace sections do not transfer directly to thin-wall / micro-feature medical work.
Our Machining Approach
We select cutting parameters, micro-tool geometry, and tool coatings around the thinnest wall and the smallest feature on the drawing. Where the geometry requires it, 3-axis / 4-axis / 5-axis CNC machining is used to maintain access and datum control, with dedicated workholding sized to the implant envelope. In-process measurement, tool-compensation, and conservative finishing passes are used to manage micro-feature fidelity. Final dimensional inspection is conducted against the drawing GD&T and the agreed inspection plan.
Engineering Outcome
For suitable, validated geometries the machining process can target linear dimensional tolerance up to ±0.005 mm and GD&T positional tolerance up to 0.01 mm, with thread forms and micro-features held to the drawing-specified limits. These are project-specific precision targets, not universal guarantees — final tolerance commitment is confirmed after CAD, drawing, material condition, feature geometry, and inspection method review.
03
Sterilization Compatibility and Finishing
Engineering Challenge
Finished implants must withstand the customer validated sterilization cycle — typically steam autoclave, gamma irradiation, or ethylene oxide (EtO) — without surface degradation, dimensional change, or coating failure. Surface roughness alone does not establish fatigue performance, corrosion resistance, or compatibility with the sterilization route. Anodized color coding (commonly used for surgical size identification) must remain stable through the agreed cycle.
Our Machining Approach
We define the finishing sequence around the customer downstream sterilization and the implant functional requirements. Depending on the agreed process, this may include surface preparation per ASTM F86, electropolishing for low surface roughness on articulating surfaces, Type II or Type III anodizing for color coding, controlled cleaning, and packaging in the agreed clean-room class. Process parameters and acceptance criteria are documented in the agreed inspection plan.
Engineering Outcome
Surface compatible with the agreed sterilization route, documented surface-finish values at designated inspection locations, defined acceptance criteria for critical surfaces and edges, and packaging suitable for clean-handling at the customer incoming inspection. Heat treatment, anodizing, and sterilization parameters remain subject to the customer regulatory qualification of the finished device.
Flexible Supply Chain
From Single-Piece Implant Prototype to Repeatable Production
Medical device development typically needs rapid design validation before locking the production drawing and the sterilization route. Our commercial model supports 1-piece prototype evaluation, surface-finish qualification, and subsequent production planning without requiring a large initial order.
| Commercial Parameter | Prototype / Engineering Validation | Production |
|---|---|---|
| Minimum order quantity | 1 piece | Based on the production order |
| Indicative lead time | 5–7 working days | 3–4 weeks |
| Typical objective | Validate fit, critical dimensions, GD&T, surface finish, sterilization compatibility | Establish repeatable output against the approved drawing and inspection plan |
| Surface preparation | ASTM F86 passivation, electropolish, or anodizing per the agreed route when specified | Scheduled according to the approved process route |
| Material documentation | As agreed in the purchase specification | MTR, ELI interstitial verification, and traceability per the order |
Lead times are planning targets, not automatic guarantees. They begin after the required technical information, material availability, order approval, and production arrangements are confirmed. Complex geometry, external processing (passivation, electropolish, anodizing), inspection requirements, and customer-supplied medical-grade material may affect the schedule.
Customer-Supplied Material
Use Approved Medical-Grade ELI Stock
For medical device development, the source of the wrought Ti-6Al-4V ELI bar / billet is itself a regulatory control point. Customer-supplied material is accepted by prior agreement, subject to specification review, incoming inspection, ELI interstitial verification, identification, and traceability requirements.
We can review the relationship between incoming stock size, finished-part envelope, machining allowance, and expected chip generation during DFM. Buy-to-Fly ratio depends on the starting material form and mass, finished-part mass, nesting or stock strategy, and process route. It is evaluated as a project-specific material-efficiency measure rather than a guaranteed percentage reduction.
Customer-Supplied Stock — What It Helps With
- Retain purchasing control over approved medical-grade ELI stock from qualified suppliers.
- Use existing inventory or centrally managed material allocations.
- Reduce the need to finance additional raw material through the machining supplier.
- Improve visibility into material utilization and scrap exposure.
Commercial & Project Protection
- Mutual NDA available before sensitive CAD files or technical drawings are exchanged.
- MTR documentation and ELI interstitial verification for material covered by the agreed traceability requirements.
- RFQ review covering material, tolerances, finish, sterilization, inspection, and delivery requirements.
- Customer-supplied stock accepted subject to technical and quality approval.
Applications
Titanium Parts That Perform Where It Matters
From aircraft structures to surgical implants, precision titanium machining delivers the strength, bio-compatibility, and corrosion resistance that demanding industries rely on.
[Aerospace Structural Element] AERO
Aerospace Structural Elements
Brackets, fittings & frames machined from Grade 5 Ti-6Al-4V under AS9100D-controlled processes.
[Orthopedic Bone Screw] MED
Orthopedic Bone Screws
Implant-grade Grade 23 ELI (Ti-6Al-4V ELI) parts machined in cleanroom-controlled environments.
[Marine Valve Components] MAR
Marine Valve Components
Corrosion-resistant titanium valves, shafts & housings engineered for extreme offshore service.
[Motorsport Fasteners] MTR
Motorsport Fasteners
High-strength titanium bolts, studs & hardware for racing and high-performance vehicles.
Submit Your Engineering Package
Have a Ti-6Al-4V ELI Implant Component Ready for Manufacturing?
Send your drawing to initiate a technical review of manufacturability, dimensional requirements, ELI material specifications, surface preparation, sterilization compatibility, and the proposed machining route. The review starts with the actual component — not a generic capability list.
Accepted file formats: STEP, STP, DXF, and supporting engineering drawings in agreed formats.
For an efficient review, include:
- 3D CAD model and dimensioned 2D drawing
- Material grade, product form, applicable specification (ASTM F136, ISO 5832-3, ASTM B348, AMS 4930)
- Critical dimensions and GD&T callouts
- Required surface finish, ASTM F86 passivation, electropolishing, and color-code anodizing
- Agreed sterilization route (autoclave, gamma, EtO)
- Prototype quantity or forecast production volume
- Inspection, certification, and documentation requirements
- Target delivery date and shipping destination
What Happens Next
- 1
Drawing and Specification Review
We review the component geometry, material requirements (ELI vs standard), critical features, surface-finish targets, and available manufacturing information.
- 2
DFM and Process Feasibility
We identify potential machining constraints, thin-wall and micro-feature risks, sterilization compatibility, datum considerations, finishing requirements, and any information needed to finalize the process route.
- 3
RFQ and Delivery Planning
We prepare a quotation based on the confirmed scope, including material responsibility, manufacturing operations, surface preparation, sterilization-compatible finishing, inspection requirements, lead time, and documentation.
Target response: Initial RFQ acknowledgment within 24 hours on working days, with a DFM review and quotation timeline confirmed according to drawing completeness and project complexity.
Confidentiality Comes First
Mutual NDA available before technical file exchange. We treat customer drawings, CAD models, specifications, and project information as confidential under the agreed contractual terms. Finished-device regulatory responsibility — including FDA / CE / NMPA submission, sterilization validation, and finished-device biocompatibility testing — remains with the customer.
Related Capabilities
Continue the Engineering Review
3/4/5-Axis Titanium Machining
Axis configuration selection for medical implants
/titanium-cnc-machining-services/3-5-axis-cnc-machining/ →
Grade 5 Ti-6Al-4V Machining
Aerospace / industrial counterpart of Grade 23
/titanium-cnc-machining-services/grade-5-titanium-cnc-machining/ →
Grade 23 ELI Material Data
Composition, mechanical properties, and forms
/materials/grade-23/ →
Compliance Hub
Medical device quality management scope
/capabilities/compliance/ →
Submit Grade 23 RFQ
Upload drawing for DFM engineering review
/rfq/ →
Grade 2 CP-Ti Machining
CP-Ti counterpart — chemical / marine / biomedical focus, ASTM B348, ASTM B600 surface preparation.
/titanium-cnc-machining-services/grade-2-titanium-cnc-machining/ →
Grade 9 Ti-3Al-2.5V Machining
Near-alpha counterpart — aerospace hydraulic tubing, AMS 4943.
/titanium-cnc-machining-services/grade-9-titanium-cnc-machining/ →
Frequently Asked Questions
Grade 23 Ti-6Al-4V ELI CNC Machining — Engineering FAQ
Q1 What is Grade 23 titanium and how does it differ from Grade 5?
Grade 23 titanium is the ELI (Extra Low Interstitials) variant of Ti-6Al-4V, designated UNS R56407. Compared to Grade 5 (UNS R56400), it has tighter upper limits on oxygen, nitrogen, carbon, and iron. The lower interstitial content improves ductility, fracture toughness, fatigue life, and biocompatibility — making it the specified alloy for surgical implants per ASTM F136 and ISO 5832-3.
Q2 Is Grade 23 ELI required for medical implants?
For finished implants placed in contact with bone, soft tissue, or body fluids, ASTM F136 (Grade 23 ELI) and ISO 5832-3 are the most commonly cited material specifications. The ELI chemistry reduces the risk of adverse biological response and improves fatigue performance under cyclic load. Material conformity is reviewed against the customer specification; finished-device compliance remains the customer regulatory responsibility.
Q3 What surface finish and post-processing is required for medical-grade parts?
Surface-finish targets depend on the implant function. Load-bearing articulating surfaces typically require very low Ra (achievable via electropolishing), while bone-contact surfaces may need controlled micro-roughness for osseointegration. Passivation per ASTM F86, electropolishing, and Type II / Type III anodizing for color coding are common secondary operations. Final finish requirements are confirmed against the customer drawing and the agreed inspection plan.
Q4 What sterilization methods are compatible with Grade 23 Ti-6Al-4V ELI?
Ti-6Al-4V ELI is compatible with the three primary sterilization methods used in medical device manufacturing: steam autoclave (typically 134 °C / 18 min), gamma irradiation, and ethylene oxide (EtO). The alloy does not degrade under standard validated sterilization cycles, and finished surface treatments (passivation, electropolish, anodize) are selected to remain stable through the agreed sterilization route.
Q5 What is the minimum order quantity for a Grade 23 prototype?
A 1-piece minimum order quantity is supported to allow engineering teams to evaluate fit, critical dimensions, GD&T, and surface finish before committing to a production run. Indicative prototype lead time is 5–7 working days, subject to drawing completeness, material availability, inspection scope, and any agreed secondary operations such as passivation or anodizing.
About Boze Titanium Manufacturing Center
One Metal. One Focus. Infinite Precision.
Founded in 2011 in Baoji's Titanium Valley, BOZE Metal is dedicated exclusively to titanium — from raw material to precision engineering. AS9100D, & ISO 9001 certified with 500+ clients across Aerospace, Medical & Motorsport industries, we deliver end-to-end precision titanium CNC machining with full material traceability from source to component.
Boze Titanium Manufacturing Center is operated by Baoji Boze Metal Products Co., Ltd.
Certifications verified by ASTM International titanium material specifications (B265, B348, B381, F136, F2924) with full EN 10204 3.1 mill test certification. Our quality system is operated under AS9100D by Baoji Boze Metal Products Co., Ltd.
AS9100D ISO 9001 500+ Clients 15+ Years OEM/ODM