Medical Sensor Iron Rods

Medical Sensor Iron Rods

"Beilun Metal's Medical-Grade Iron Rods deliver surgical precision for sensor manufacturing. ISO 13485-certified biocompatible alloy with 0.8µm surface finish. Features 99.95% Fe purity, autoclave-safe construction, and MRI compatibility. Custom diameters 2-25mm (±0.02mm). FDA-compliant material traceability."
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Description

Medical Sensor Iron Rods | Biocompatible Precision Components
ISO 13485-Certified · MRI-Safe · Sterilization-Ready


 

Clinical-Grade Material Engineering

Precision-crafted for medical diagnostic equipment and implantable sensor systems, our rods undergo 23-stage purification to achieve ultra-low impurity levels exceeding EN ISO 10993 biocompatibility standards.

 

Medical Alloy Composition (USP <797> compliant):

Element Medical Grade Industrial Grade
Fe ≥99.97% ≥99.90%
C 0.02-0.05% 0.10-0.18%
Surface Ni <0.001% 0.005-0.03%
Residual Stress <15MPa 30-50MPa

 

Critical Healthcare Applications

Diagnostic Imaging

MRI coil structural cores (non-ferromagnetic certification)

CT scanner sliding components

Ultrasound transducer bases

Implantable Devices

Neural sensor guide wires (Ø1.5-3.0mm variants)

Glucose monitor chassis frames

Surgical robot articulation joints

Laboratory Systems

Automated analyzer transport rails

Centrifuge rotor shafts

Sterilization tray frameworks

 


 

Medical Compliance Features

△ Bio-Safety Validation

Cytotoxicity Testing: ISO 10993-5 Class A

Pyrogen-Free Certification

500-cycle autoclave validation (134°C/3bar)

△ Precision Manufacturing

Diameter Range: 1.5mm-30mm (±0.008mm)

Surface Roughness: Ra 0.4-0.8µm (mirror finishing available)

Straightness: ≤0.03mm/300mm

△ Traceability

Lot-specific material genealogy reports

Electropolishing validation certificates

Full FDA 21 CFR Part 11 compliance


 

Performance Benchmarking

 

Parameter Beilun Medical Grade Industry Average
Corrosion Resistance 3000h salt spray 500h
Magnetic Permeability 1.003 μ/μ0 1.85 μ/μ0
Thermal Conductivity 72 W/m·K 64 W/m·K
Yield Strength 280-320 MPa 180-220 MPa

 

Customization Protocol

Stage 1: Design Validation

Material compatibility simulation

Sterilization cycle mapping

Stage 2: Prototyping

Micro-tolerance machining (CNC/EDM)

Passivation treatment options

Stage 3: Certification

Third-party biocompatibility testing

Cleanroom packaging validation

 


 

Technical Documentation

CE Marking Technical File

USP Class VI Certification

Electromagnetic Compatibility (EMC) Reports

RoHS 3/REACH SVHC Declaration

 


 

Q&A: Medical Compliance

Q: Maximum continuous operating temperature?
A: 180°C for 10,000hr service life

Q: Post-processing recommendations?
A: Electropolishing to Ra 0.2µm + medical-grade passivation

Q: Lead time for validated prototypes?
A: 6-8 weeks with full test reports

Q: Packaging sterility levels?
A: Option for ISO Class 5 cleanroom packing

 


Why Beilun Metal?
✓ 10 Years Medical Device Supply Experience
✓ Class 1000 Cleanroom Production Cell
✓ Material Master Files Available for FDA Submissions

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