Titanium TAVI Frame is a precision-manufactured transcatheter aortic valve component designed for Transcatheter aortic valve replacement frame (Nitinol). Fabricated from Nitinol, this component meets the stringent requirements of sterile surgical environments including corrosion resistance to bodily fluids, compatibility with repeated autoclave cycles, and non-magnetic properties for MRI compatibility.
Titanium TAVI Frame
| Technical Parameter | Specification |
|---|---|
| Component SKU | TI-MD-CAR-TITANI |
| Standards & Specifications | ASTM B348 |
| Surface Finish | Passivation ASTM F86 (20-30% HNO3, 30min @50C) |
Titanium TAVI Frame
Transcatheter aortic valve replacement frame (Nitinol)
| Technical Parameter | Specification Value |
|---|---|
| International Compliance | ASTM B348 |
| Surface Finish & Max Temp | Passivation ASTM F86 (20-30% HNO3, 30min @50C) |
- • 100% Traceability: Mill Test Certificate (EN 10204 3.1) with heat analysis & mechanical testing.
- • Compliance: REACH, RoHS 3 certified. FAI AS9102 available.
- • Process: CNC precision machining, vacuum stress relief, thread rolling, surface passivation.
- • Thermal Stress Relief: Post-machining vacuum annealing (540-675°C under Argon) reduces distortion risk >70%.
- • Rolled Threads: Thread rolling (not cutting) increases fatigue limits by 30-50%.
Q: Is Titanium TAVI Frame MRI-safe or MRI-conditional? ▼
Nitinol is non-ferromagnetic (magnetic susceptibility 1.00005 × 10⁻⁶ cgs) and generates negligible MRI artifact compared to 316L stainless steel. Titanium TAVI Frame is classified as MR-Conditional under ASTM F2052/F2213 testing at 1.5T and 3.0T field strengths. Specific absorption rates remain within safe limits for transcatheter aortic valve configurations.
Q: What is the typical lead time for Titanium TAVI Frame orders? ▼
Standard lead time for Titanium TAVI Frame is 15-25 business days depending on quantity and complexity. Rush orders (3-5 working days) are available for prototype evaluation. Sample evaluation (1-5 units) can be expedited to 5-7 business days. Volume pricing is available for production quantities above 100 units.
Q: What material certifications are provided with Titanium TAVI Frame? ▼
Each Titanium TAVI Frame shipment includes EN 10204 Type 3.1 mill test certificate with chemical analysis, mechanical properties, and heat identification. Dimensional inspection reports and Certificate of Conformance (CoC) are standard. First Article Inspection Reports (FAIR) per AS9102 are available on request for transcatheter aortic valve.
§ Why Nitinol for transcatheter aortic valve
Function
Designed for Medical Device applications, this component fulfills the role of . The use of Nitinol (ASTM F2063) ensures long-term reliability in this Cardiovascular configuration.
Specifications
- SKU: TI-MD-CAR-TITANI
- Category: Cardiovascular
- Industry: Medical Device
- Material: Nitinol (ASTM F2063)
- Process: CNC precision machining, vacuum stress relief, thread rolling, surface passivation
- Weight: 35-45% lighter than steel equivalents at equivalent section modulus
§ Biocompatibility & Dimensional Inspection
Quality Management
ISO 9001:2015 quality management system. Every Titanium TAVI Frame shipment includes EN 10204 3.1 MTR, CMM report, and surface finish certification.
Inspection & NDT
Automated optical inspection with sub-micron resolution; X-ray CT scanning for internal feature validation; surface profilometry for finish compliance
§ Surgical-Grade Manufacturing Process
Titanium TAVI Frame is manufactured using cnc precision machining, vacuum stress relief, thread rolling, surface passivation. Each operation is performed by certified machinists with real-time process monitoring and dimensional verification at critical stages. Heat code traceability is maintained throughout all production steps.
Commercial Logistics & Procurement Framework
Pricing and lead times for Titanium TAVI Frame are batch-dependent. Contact our supply chain team for volume-based tiered pricing.
Regulatory & Quality Assurance Ledger
Verifiable certifications for Titanium TAVI Frame
Material Test Certificate (MTC)
EN 10204 3.1
Environmental Compliance
REACH (EC No 1907/2006)
Restricted Substances
RoHS 3 Directive (2015/863/EU)
Quality Management System
ISO 9001:2015
Dimensional Tolerances
ISO 2768-m
Standard: ASTM B348
Systems Interconnectivity & Topology
Cross-functional integration matrix for Tier-1 supply chains and assembly orchestration.
- ▸ Primary Assembly Integration
- ▸ Subsystem Mounting Interface
Titanium TAVI Frame
Material: Nitinol (ASTM F2063)
SKU: TI-MD-CAR-TITANI
Industry: Medical Device / System: Cardiovascular Stent & TAVI Frames
- ▸ Fastener Kit A
- ▸ Sealing Gasket
- ▸ Protective Cover
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Founded in 2011 in Baoji's Titanium Valley, BOZE Metal is dedicated exclusively to titanium — from raw material to precision engineering. AS9100D, ISO 13485 & 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 CNC Ti is the dedicated titanium manufacturing center of Baoji Boze Metal Products Co., Ltd.