You can find big differences in nitinol tubing grades and specifications for medical use. These differences change how safe and useful your device is. When you pick nitinol, you look for things like biocompatibility, corrosion resistance, and fatigue resistance. These things help make nitinol a good choice for stents and implants. Here are some common tubing types:
Material Type | Composition | Standard | Diameter | Surface Finish |
|---|---|---|---|---|
Nitinol | NiTi, NiTiFe, NiTiCu, NiTiCo, NiTiCuCr, NiTiNb | ASTM F2063-12 | ≥0.25 mm, or customized | Black, Pickled, or Polished |
You must choose carefully for 2026 medical uses. AccuPath gives trusted solutions to help you.
Nitinol tubing has three grades: standard, precision, and premium. Pick the grade that fits your device’s needs for working well and being safe.
Superelastic nitinol tubing lets devices bend and go back to their shape without heat. This is good for stents and guidewires that move inside the body.
Shape memory nitinol tubing keeps its shape until you heat it. Use this kind for tools that must change shape during medical work.
Make sure nitinol tubing follows ASTM F2063 rules. This helps keep medical devices safe and working right.
Think about ways to customize nitinol tubing. Changing size, wall thickness, and surface finish can help devices work better and keep patients safe.
When you pick nitinol tubing for medical devices, you should know about the different grades. There are standard, precision, and premium grades. Each grade has special features that change how your device works. You can look at the tables below to see the main differences.
Tubing Grade | OD Range (mm) | OD Tolerance (µm) | Concentricity Tolerance |
|---|---|---|---|
Standard | 0.254-1.65 | 10.2 - 25.4 | N/A |
Precision | 1.65 - 5 | 12.7 - 25.4 | >90% |
Premium | 1.65 - >5 | 12.7 - 20.3 | >95% |
Grade | OD Range (inches) | OD/ID Ratio | OD Tolerance (inches) | Concentricity Tolerance | Alloy/Ingot Quality |
|---|---|---|---|---|---|
Standard | 0.010 - 0.065 | 1.11 - 2.67 | +0.0003 to +0.001 | N/A | Standard |
Precision | 0.065 - 0.197 | > 1.08 | ±0.0005 | > 90% | Standard |
Premium | 0.065 - 0.197 | > 1.08 | ±0.0005 | > 95% | Standard & Enduro |
Standard nitinol tubing is good for simple medical uses. Precision grades have tighter tolerances and better concentricity. This means your device will work more the same every time. Premium grades give you the best accuracy and quality. You should use premium nitinol tubing when your device must be very reliable, like in important implants.
There are two main types of nitinol tubing. These are superelastic and shape memory grades. Each type changes how your device acts and works.
Feature | Superelastic Nitinol Tubing | Shape Memory Nitinol Tubing |
|---|---|---|
Main Mechanism | Stress-induced phase change | Temperature-induced phase change |
Behavior | Returns to shape after bending (no heat) | Holds new shape until heated |
Activation | Needs only force above transformation temp | Needs heating above set temperature |
Recovery Speed | Immediate | Delayed (after heating) |
Typical Strain Limit | Up to 4% | Up to 8% (after heating) |
Malleability | Not malleable at room temperature | Malleable below transformation temperature |
Fatigue Resistance | Very high | High, but depends on cycling and heating |
Common Applications | Stents, guidewires, eyeglass frames | Actuators, couplings, surgical tools |
Superelastic nitinol tubing lets your device bend and go back to its shape without heat. This helps you make stents and guidewires that move through blood vessels and then open up. Shape memory nitinol tubing keeps a new shape until you heat it. You can use this kind for tools or actuators that need to change shape during surgery.
Tip: Superelastic nitinol tubing helps you make devices smaller and more flexible. Shape memory nitinol tubing lets you control when your device changes shape.
The mechanical properties of nitinol tubing change how your device works in the body. Superelasticity lets you make small devices that can expand by themselves. This is important for stents and filters. Shape memory effect lets your device go back to a set shape, which helps it work better. Both types are safe for the body and last a long time.
You need to look at the alloy composition when you pick nitinol tubing. Most medical nitinol tubing has about 50% nickel and 50% titanium. Some nitinol alloys, like nitinol 55, have more nickel, such as 55.8% nickel. The mix of nickel and titanium gives nitinol its special features, like shape memory and superelasticity.
The 50/50 nickel-titanium mix makes nitinol tubing strong and bendy.
More nickel in nitinol alloys can change how the tubing acts with heat and stress.
The right alloy mix makes sure your device is safe and works well.
You should always check that your nitinol tubing meets ASTM F2063 standards. These rules say what the chemical mix and mechanical properties must be. If you use nitinol tubing that follows ASTM F2063, your device will be safe and work well. AccuPath gives nitinol tubing that meets these rules, with full paperwork and outside testing.
Makers must keep good records of the nitinol alloys they use.
Labs test nitinol tubing to make sure it meets ASTM F2063.
Certification helps you trust the quality and sameness of your nitinol tubing.
Note: Picking nitinol tubing that meets ASTM F2063 standards helps you avoid problems and makes sure your device works right.
It is important to know the size and wall thickness when picking nitinol tubing for medical devices. Nitinol tubing comes in many sizes. Most medical tubing has outer diameters from 0.2 mm to 2 mm. Dental devices sometimes use tubing from 0.5 mm to 3 mm wide. Wall thickness can be very thin, down to 0.05 mm. Some ultra-fine tubing can be as thin as 0.0007 inches. Thin walls make tubing more flexible. Thicker walls give tubing more strength for tough jobs.
Tubing Type | Outer Diameter (OD) Range | OD Tolerance |
|---|---|---|
Single-Lumen | From 0.003" (0.076 mm) | From ±0.0003" (±0.008 mm) |
Single-Lumen Ultrathin Wall | 0.004" – 0.120" (0.102 mm – 3.048 mm) | From ±0.0002" (±0.005 mm) |
Single-Lumen Microthin Wall | 0.020" – 1" (0.508 mm – 25.4 mm) | From ±0.0004" (±0.001 mm) |
You can pick nitinol tubing with the right size and wall thickness for your device. Thin wall tubing is best for devices that need to bend and move. Thicker tubing is better for devices that must hold more weight.
Thin wall nitinol tubing gives many benefits for medical devices. It is flexible and does not kink easily. This helps you guide devices through small spaces in the body. Thin wall tubing keeps its shape after bending. You can use it for stents, catheters, and guidewires. Devices like the WATCHMAN FLX™ use thin wall tubing to help prevent strokes by moving safely in blood vessels.
Thin wall nitinol tubing lets you make devices that bend but do not break.
You can use thin wall tubing for neurovascular stents. These stents have sizes from 0.2 mm to 2 mm and wall thicknesses from 0.05 mm to 0.3 mm.
Thin wall tubing works well for catheters and guidewires. It does not kink and stays strong after many bends.
Tip: Thin wall nitinol tubing is both flexible and strong. This helps your devices move easily and last a long time.
Thin wall nitinol tubing is special because it bends and goes back to its shape. This is because of superelasticity and shape memory. You can trust thin wall tubing to work well even after many uses.
You can change how nitinol tubing acts by picking different sizes, wall thicknesses, and surface finishes. Nitinol tubing is both strong and flexible. This is important for orthopedic tools and implants. Thin wall tubing is not good for heavy loads. But you can use gradient wall thickness to make some parts flexible and other parts strong.
Nitinol tubing can handle millions of stress cycles. This means heart valves and stents can last longer.
You can choose nitinol tubing with special coatings or finishes. These help with biocompatibility and corrosion resistance.
Precision machining lets you make nitinol tubing with exact shapes and sizes for your device.
Customization Aspect | Description |
|---|---|
Surface Modifications | Electropolishing and coatings make tubing safer and stronger. |
Precision Machining | Laser cutting and CNC machining help create detailed designs. |
Size and Shape Adjustments | You can change the size, wall thickness, and shape for better results. |
Special Surface Finishes | Polishing and coatings help your device work in hard places. |
You can work with experts to design nitinol tubing that fits your device. Thin wall tubing gives flexibility. Thicker tubing adds strength. Custom nitinol tubing helps you meet the needs of each patient and procedure.
Nitinol tubing is used in many medical devices. It is special because it is both strong and flexible. Here are some ways doctors use it:
Guidewires and delivery systems: Nitinol tubing bends without breaking or kinking. This helps doctors move tools through tricky parts of the body.
Orthodontic archwires: Nitinol gives a gentle and steady push. This makes braces more comfortable for patients.
Orthopedic implants: Nitinol’s shape memory lets it work for bone anchors and staples. These help bones heal with less surgery.
Neurovascular stents: Nitinol tubing makes these stents bendy and tough. They can fit into tiny blood vessels in the brain.
Surgical tools: Nitinol tubing helps make tools that bend and snap back to shape.
Superelastic nitinol tubing helps make devices for many jobs. You can count on these devices to work well inside the body.
Nitinol tubing is safe for medical devices because it works well with the body. A thin titanium oxide layer forms on the tubing. This layer keeps the tubing safe and stops bad reactions. Nitinol does not let out much nickel, so allergies are rare. You can make nitinol even safer by using surface treatments like electropolishing.
Nitinol tubing does not rust easily like other metals. The table below shows how nitinol compares to other materials:
Material | Ion Release Risk | Surface Treatment Impact | |
|---|---|---|---|
Nitinol | Superior | Low | Enhanced by treatments |
Stainless Steel | Moderate | Moderate | Limited |
Cobalt-Chromium | Moderate | High | Limited |
Neurovascular stents made from nitinol tubing last a long time. They stay safe inside the body.
You can keep nitinol tubing safe in medical devices by doing these things:
Learn about nitinol’s features. Know how changing the alloy changes flexibility and strength.
Control heat when making nitinol tubing. Use special lasers to stop tiny cracks.
Use surface treatments. Electropolishing and chemical etching make nitinol tubing smoother and safer.
Check quality at every step. Handle nitinol tubing carefully and use trained workers.
Tip: Always pick nitinol tubing that meets high quality rules. This helps you make safe neurovascular stents and other devices for patients.
Neurovascular stents and other devices need nitinol tubing that is strong, bendy, and safe. You can trust nitinol for many medical devices because it does all these things.
When you pick nitinol tubing for a medical device, you need to think about how bendy it is, how strong it is, and if it works well with other materials. Flexibility helps your device move through the body’s small spaces. Strength keeps your device working during hard jobs. Nitinol gives you both because of its shape memory and superelasticity. You also want nitinol tubing that is safe for people and does not cause bad reactions.
Here are important things to think about:
Factor | Description |
|---|---|
Material Quality | Strong nitinol stays in shape and bends without breaking. |
Biocompatibility | Nitinol tubing must be safe for people and not cause allergies. |
Customization Options | Custom tubing lets you pick the right size, bendiness, and strength for your device. |
Regulatory Compliance | Nitinol tubing should follow safety rules like ASTM F2633-07. |
Supplier Reliability | A good supplier gives you quality nitinol tubing on time. |
Cost-Effectiveness | You want to keep costs low but still get good quality. |
Flexibility helps your device move through tight spots.
Strength makes sure your device lasts and works well.
Superelasticity in nitinol tubing helps in many medical tools.
You can choose standard nitinol tubing or custom tubing for your device. Standard tubing works for many simple tools. Custom tubing gives you more choices for size, wall thickness, and shape. You can ask for custom tubing if you need special features.
Advantages | Disadvantages | |
|---|---|---|
Seamless Nitinol | Strong, bendy, smooth surface, fewer weak spots | Costs more, harder to make special sizes |
Welded Nitinol | Cheaper, faster, good for simple tools | Weaker seams, less bendy, not for custom use |
Custom tubing helps you design devices for special jobs. You can ask for custom nitinol tubing with special finishes or coatings. This makes your device safer and stronger.
Tip: Pick custom tubing when you need exact sizes or special shapes for your device.
You can work with AccuPath to get the best nitinol tubing for your project. AccuPath listens to what you need and offers custom tubing solutions. They can change the size, wall thickness, and surface finish to fit your device. Their team checks every step to make sure your custom nitinol tubing follows all rules and works well in the body.
AccuPath’s experts help you pick the right custom tubing for your device. They focus on quality and fast delivery. You can trust AccuPath for custom nitinol tubing that fits your medical device needs.
You must follow strict rules when using nitinol tubing. ASTM F2063 gives the main safety and quality rules. Agencies check if you follow these standards. ISO 13485 shows your company uses safe steps for medical nitinol. ASTM F2082 adds more safety rules. These rules help nitinol tubing work well in life-saving devices.
ASTM F2063 and ASTM F2082 set safety and quality rules.
ISO 13485 proves your company follows global medical device rules.
Agencies check if you follow these standards.
Here is a quick look at rules in different places:
Region | Regulatory Requirement |
|---|---|
United States | FDA requirements |
Europe | CE marking |
Asia | Rules change by country, less standard |
You must test nitinol tubing to make sure it is safe. Biocompatibility tests follow ISO 10993 and ASTM F2063. You need to check for cytotoxicity, nickel release, and strength. Certified nitinol tubing can lower problems by up to 25%. Use advanced cleaning and electropolishing to make nitinol safer.
Parameter | Standard/Requirement |
|---|---|
Biocompatibility Testing | ISO 10993, FDA, ASTM F2063 |
Fatigue Life | Over 600 million cycles |
Nickel Release | Less than 75 ppb with passivation |
OD Tolerance | ±0.005mm for OD over 0.80mm |
Safety | Most important |
Tip: Always pick nitinol tubing that passes all safety tests. This keeps patients safe and makes your devices work well.
Getting medical nitinol tubing is not easy. Only a few suppliers offer high-purity nitinol tubing. Strict rules for mining and making nitinol make it harder. Production delays can last 8 to 20 weeks. Nickel and titanium prices change often, so costs go up and down. Companies use better machines and automation to speed up delivery. Good supply chain management helps you get nitinol tubing on time and keeps quality high.
Consideration | Details |
|---|---|
Supplier Limitations | Few suppliers for medical nitinol tubing |
Regulatory Compliance | Strict rules for mining and making |
Production Delays | 8 to 20 weeks is normal |
Cost Variability | Nickel and titanium prices change a lot |
Technological Improvements | Better machines and automation help reduce delays |
Supply Chain Management | Full control keeps quality and delivery good |
Note: Fast delivery of nitinol tubing is important for healthcare. Work with suppliers who control their supply chain and use new technology.
You should know the big differences in nitinol tubing grades and specifications before you choose one for medical use. These differences change how your device works, how safe it is, and if it fits what you need. The table below shows the most important things to think about:
Factor | Why It Matters |
|---|---|
Af Temperature | Makes sure nitinol works at body temperature |
Fatigue Resistance | Lets tubing last through millions of bends |
Biocompatibility | Keeps patients safe from swelling or rejection |
Size and Tolerances | Matches your device’s exact needs |
Surface Finish | Improves safety and smoothness |
Supplier Quality | Gives you reliable and safe tubing |
When you pick nitinol tubing, remember these tips from experts:
Make sure the tubing passes FDA rules and biocompatibility tests.
Find tubing made with advanced machines and custom choices.
Talk to experts often and learn about new rules for 2026. AccuPath can help you get the best nitinol tubing for your next medical device.
Nitinol tubing can bend and then go back to its shape. Doctors use it for stents and guidewires. Superelasticity and shape memory help devices work well in the body.
Think about what your device needs. Standard grades are good for simple tools. Precision and premium grades are more exact and reliable. Always check if the tubing follows ASTM F2063 rules.
Nitinol tubing has a titanium oxide layer on it. This layer keeps nickel from reaching patients. Surface treatments like electropolishing make it even safer. Most medical nitinol tubing passes tough safety tests.
Yes, you can get custom sizes, wall thicknesses, and finishes. Custom tubing helps your device do special jobs. You can also ask for coatings to make it safer and work better.
Most suppliers take 8 to 20 weeks to deliver nitinol tubing. You should plan early and work with trusted suppliers like AccuPath to avoid waiting too long.
The Manufacturing Process of Nitinol Tubing for Medicine
The Importance of Nitinol Tubing in Modern Medicine
Nitinol Tubing's Impact on the Future of Medical Devices