Medical Stainless Steel Tubing ISO 13485 Compliant ASTM F2181 Compliant Precision Steel Tube for Medical Devices
製品詳細
ISO 13485 Compliant Medical Stainless Steel Tubing
,ASTM F2181 Compliant Precision Steel Tube
,ASTM A269 Compliant Stainless Steel Tubing
Medical Stainless Steel Tubing (Small Diameter) for Medical Devices
Material
This product is a precision stainless steel small-diameter tubing designed specifically for medical devices. It is manufactured from medical-grade stainless steels such as 304/304L, 316/316L, and 17-7PH using cold-drawing or seamless production methods. The process ensures ultra-smooth surfaces, excellent dimensional accuracy, high structural integrity, and full biocompatibility.
Specifications
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Outside Diameter (OD): approx. 0.15 mm to 6 mm for miniature medical tubing
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Wall Thickness: from about 0.025 mm and above
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Dimensional Tolerance: OD and wall thickness tolerances can reach ±0.001 in depending on the size
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Available Grades: 304, 304L, 316, 316L, 316LVM, 316Ti, 17-7PH
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Surface Finish: polished or electropolished; internal Ra value can reach ≤0.2 µm
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Form: straight lengths or coils; cut-to-length available
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Production Method: cold drawing, plug drawing, seamless or welded-and-drawn processing
Key Features
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High corrosion resistance and excellent biocompatibility
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Very tight dimensional control for OD/ID and wall uniformity
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Smooth internal surfaces suitable for fluid and gas delivery
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High straightness and consistency for precision assembly
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Suitable for sterilization and repeated clinical use
Our Advantages
1. Tight Tolerances & Straightness
Our production achieves extremely precise OD, ID, and wall thickness control, with tolerances up to ±0.01 mm, meeting demanding medical device requirements such as minimally invasive instruments and catheter systems.
2. Medical-Grade Material Control
All stainless steel materials are fully certified, traceable, and compliant with medical manufacturing standards. Each batch undergoes strict inspection to ensure consistency and purity.
3. Superior Surface Cleanliness
Through precision drawing and electropolishing, tubing surfaces maintain minimal contamination and extremely low roughness, essential for medical fluid systems and surgical tools.
4. Advanced Manufacturing Capabilities
We can produce ultra-small inside diameters (as small as 0.13 mm) and ultra-thin walls using cold-drawing and plug-drawing technologies.
5. Full Customization for Medical OEMs
Custom lengths, bending, coiling, flaring, and end-forming are available. Outer diameters can be produced up to 20 mm for special medical assemblies.
6. Compliance with Medical Quality Systems
Production aligns with ISO 13485 requirements, ensuring full documentation, traceability, and process control suitable for medical device manufacturing.
Chemical Composition
| Grade | C ≤ | Mn ≤ | P ≤ | S ≤ | Si ≤ | Cr (%) | Ni (%) | Mo (%) | Remarks |
|---|---|---|---|---|---|---|---|---|---|
| 304 | 0.08 | 2.0 | 0.045 | 0.030 | 1.0 | 18.0-20.0 | 8.0-11.0 | — | General medical grade |
| 304L | 0.035 | 2.0 | 0.045 | 0.030 | 1.0 | 18.0-20.0 | 8.0-13.0 | — | Low carbon version of 304 |
| 316 | 0.08 | 2.0 | 0.045 | 0.030 | 1.0 | 16.0-18.0 | 10.0-14.0 | 2.0-3.0 | High corrosion resistance |
| 316L | 0.03 | 2.0 | 0.045 | 0.030 | 1.0 | 16.0-18.0 | 10.0-14.0 | 2.0-3.0 | Low carbon grade for welding |
| 17-7PH | — | — | — | — | — | ~17.0 | ~7.0 | — | High-strength precipitation-hardening alloy |
Mechanical Properties
| Grade | Yield Strength (0.2% min) | Tensile Strength (min) | Elongation (min) |
|---|---|---|---|
| 316 | ~205 MPa | ~515 MPa | ≥40% |
| 316L | ~170 MPa | ~485 MPa | ≥40% |
| 304 | ~205 MPa | ~515 MPa | Depends on temper |
| 17-7PH | Up to ~1,400 MPa (hardened) | — | — |
| 304L | Slightly lower than 304 | — | — |
Note: Cold-worked medical tubing can achieve significantly higher strengths than annealed sheet/bar material.
Standards Compliance
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ASTM F2181 – Seamless stainless steel tubing for surgical implants
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ASTM A269 – Seamless and welded austenitic stainless steel tubing
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ISO 9626 – Stainless steel needle tubing for medical devices
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ISO 13485 – Medical device quality management system
Application Areas
General Use
Designed for medical device manufacturing requiring miniature, high-precision, corrosion-resistant stainless steel tubing.
Specific Applications
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Catheter shafts, cannulas, and delivery systems
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Hypodermic needles, syringe components, and micro-fluid channels
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Surgical and minimally invasive instruments (endoscopic, arthroscopic, etc.)
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Orthopedic and implantable device components
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Diagnostic equipment fluid lines and analytical micro-tubing
Q: Are you trading company or manufacturer ?
A: manufacturer,also can do trading.
Q: How long is your delivery time?
A: Generally speaking,it is 10-15 days if the goods are in stock,or it is 30-40 days if the goods are not in stock,
it is according to quantity.
Q: Do you provide samples? is it free or extra ?
A: Yes, we could offer the sample for free charge but need pay the cost of freight.
Q: What is your terms of payment ?
A: Payment<=2000USD, 100% in advance. Payment>=2000USD, 30% T/T in advance ,balance before shippment.
If you have another question, pls feel free to contact with me.
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