Titanium Pacemaker Enclosure is a precision-manufactured permanent pacemaker outer component designed for Permanent pacemaker outer hermetic enclosure. Fabricated from Grade 2 CP-Ti, 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.

Medical Device / Implantable Device / SKU: TI-MD-IMP-TITANI

Titanium Pacemaker Enclosure

MOQ 1 Unit
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Titanium Pacemaker Enclosure — Grade 2 CP-Ti Product Rendering
Also known as: Pacemaker caseIPG housingImplant shell
Technical Parameter Specification
Component SKU TI-MD-IMP-TITANI
Standards & Specifications ASTM B348ISO 9001
Surface Finish Bead blasted matte Ra 1.6-3.2um + passivation
Implantable Device SKU: TI-MD-IMP-TITANI

Titanium Pacemaker Enclosure

EN 10204 3.1REACHRoHS 3AS9100D
Material Grade: Grade 2 CP-Ti

Permanent pacemaker outer hermetic enclosure

Technical Specifications Matrix
Technical Parameter Specification Value
International Compliance ASTM B348, ISO 9001
Surface Finish & Max Temp Bead blasted matte Ra 1.6-3.2um + passivation
📜 Quality & Traceability Gate
  • 100% Traceability: Mill Test Certificate (EN 10204 3.1) with heat analysis & mechanical testing.
  • Compliance: REACH, RoHS 3 certified. FAI AS9102 available.
⚙️ CNC & Stress Relief Controls
  • Process: CNC turning, heat treatment, surface grinding, passivation, dimensional check.
  • 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%.
Engineering FAQ
Q: Is Titanium Pacemaker Enclosure MRI-safe or MRI-conditional?

Grade 2 CP-Ti is non-ferromagnetic (magnetic susceptibility 1.00005 × 10⁻⁶ cgs) and generates negligible MRI artifact compared to 316L stainless steel. Titanium Pacemaker Enclosure 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 permanent pacemaker outer configurations.

Q: What is the typical lead time for Titanium Pacemaker Enclosure orders?

Standard lead time for Titanium Pacemaker Enclosure 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 Pacemaker Enclosure?

Each Titanium Pacemaker Enclosure 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 permanent pacemaker outer.

Integration: Mechanical Subsystem A / Structural Carrier Assembly
Downstream: Mounting Bracket Kit / Threaded Insert Set / Torque Specification Tag
Engineering Report & Product Documentation

§ Why Grade 2 CP-Ti for permanent pacemaker outer

Function

Engineered as a Implantable Device component, this part serves the specific function of . Grade 2 CP-Ti was selected for its proven performance in Medical Device service conditions.

Specifications

  • SKU: TI-MD-IMP-TITANI
  • Category: Implantable Device
  • Industry: Medical Device
  • Material: Grade 2 CP-Ti
  • Process: CNC turning, heat treatment, surface grinding, passivation, dimensional check
  • Weight: 40% mass reduction vs standard steel components with same load rating

§ Biocompatibility & Dimensional Inspection

Quality Management

Production executed in AS9100D-certified facility. Material certificates, dimensional reports, and surface finish certifications accompany every shipment of Titanium Pacemaker Enclosure components.

Inspection & NDT

Full dimensional layout per AS9102 FAIR requirements; ultrasonic immersion scanning for volumetric integrity; micro-hardness traverse on heat-affected zones

§ Surgical-Grade Manufacturing Process

Titanium Pacemaker Enclosure is manufactured using cnc turning, heat treatment, surface grinding, passivation, dimensional check. 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

Minimum Order (MOQ) 1 Unit
Sample Evaluation 3-5 Business Days
Mass Production Lead 15-25 Business Days (Batch Dependent)
Shipping Basis EXW / FOB Shenzhen

Pricing and lead times for Titanium Pacemaker Enclosure are batch-dependent. Contact our supply chain team for volume-based tiered pricing.

Regulatory & Quality Assurance Ledger

Verifiable certifications for Titanium Pacemaker Enclosure

Material Test Certificate (MTC)

EN 10204 3.1

Verified

Environmental Compliance

REACH (EC No 1907/2006)

Verified

Restricted Substances

RoHS 3 Directive (2015/863/EU)

Verified

Quality Management System

AS9100D

Verified

Standard: ASTM B348

ASTM B348

Available upon Request

Standard: ISO 9001

ISO 9001

Available upon Request

Systems Interconnectivity & Topology

Cross-functional integration matrix for Tier-1 supply chains and assembly orchestration.

Upstream System Integration
  • Mechanical Subsystem A
  • Structural Carrier Assembly
Primary Inspected Component

Titanium Pacemaker Enclosure

Material: Grade 2 CP-Ti

SKU: TI-MD-IMP-TITANI

Industry: Medical Device / System: Medical Implants

Downstream Consumables
  • Mounting Bracket Kit
  • Threaded Insert Set
  • Torque Specification Tag

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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 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.

AS9100D ISO 13485 ISO 9001 500+ Clients 15+ Years OEM/ODM