Item

Details

Dimensional and Appearance Requirements

Inspect item by item against the drawing; all dimensions shall comply with drawing requirements, with special emphasis on key dimensions.

Appearance
Inspection

1. Tube body: smooth, free of wrinkles, cracks, peeling, pits, protrusions, etc.

2. End: smoothly cut, no delamination;

3. Internal: three-layer composite firmly bonded, no delamination; inner wall free of foreign matters.

Physical Properties

Lumen
Requirements

1. All lumens smooth and burr‑free, free of foreign matters, deformation, damage or kinking; no interconnection or interference between lumens.

2. Smooth passage and withdrawal of various instruments, fluids and gases without resistance or blockage.

Peak Tensile
Strength

Peak tensile
strength shall meet the requirements specified in Table 1, Clause 4.6 of YY 0285.1‑2017.

Bending
Resistance

Meet tip‑adjustment bending requirements; no wrinkles on the outer surface after bending with special tooling.

Leakage
Requirements

No liquid or air leakage from the tube body or welded joints.

Corrosion
Resistance

No corrosion on metallic components of the tube.

Particulates

Tested in accordance with the particulate contamination index method in YY/T 1556‑2017; particulate contamination index N ≤ 90.

Chemical Properties

Initial
Bioburden

Tested per GB/T 19973.1‑2015; ≤ 100 CFU per unit.

Biocompatibility

Biocompatibility reports or statements are available for all raw materials.

Dimension

Extrusion Coating

Reflow Bonding

Process Definition

Continuous inner layer extrusion, coiled then braided, followed by outer layer extrusion coating for lamination

Inner tube + braiding then outer tube assembly; outer layer softened and fused via heat shrink / hot air

Molding Method

Mainly extrusion molding, outer layer as melt coating

Assembly + Thermal Fusion

Production Form

Continuous coiled (long lengths)

Produced piece by piece

Labor Cost Per Unit

Low (continuous line)

Relatively high (assembly + reflow station)

Large-Scale Cost

Lower than reflow (obvious mass production advantage)

Rises with labor and complexity

Concentricity

High (depends on tooling and traction control)

Medium (depends on assembly)

Surface Appearance

Sensitive to braiding uniformity, braid texture easily visible

Relatively smoother

Risk of Wire Breakage / Weak Points

Risk exists if extrusion coating pressure is insufficient

Lower risk when outer layer material is sufficient

Variable Diameter / Graded Hardness

Difficult to achieve

Various hardness levels available

Typical Applications

Coated extrusion tubes with consistent structure, low-cost high-volume demand

Complex structure, graded design, high-end microcatheters

Core Tube (mm)

Tolerance ± (mm)

Inner Layer Wall Thickness (mm)

Tolerance ± (mm)

Wall thickness for reference only Controlled by OD in actual production

*Wall Thickness = Inner Layer OD − Core Tube OD

*Inner Layer Wall Thickness ＞ 0.2mm

Tolerance to be increased accordingly

1–2.8

0.03

0.02–0.06

0.015

2.8–3.8

0.04

0.06–0.1

0.02

3.8–5.0

0.05

0.1–0.2

0.03

Braiding Wire (mm)

PPI

Braiding patterns: 1×2, 2×2, 1×1, 16 carriers

Min braiding wire size: 0.025×0.076 mm

Max braiding wire size: 0.076×0.2 mm

0.025×0.076

35–60

0.05×0.127

35–60

0.05 round wire

35–60

0.1 round wire

35–60

0.076×0.2

35–50

Outer Layer (mm)

Tolerance ± (mm)

Actual tolerance affected by wall thickness

Applicable wall thickness: 0.05–0.2 mm

*Outer layer wall thickness ≥ braiding wire thickness

*Outer layer wall thickness ＞ 0.2mm

Tolerance range to be increased accordingly

1.2–3.2

0.03

3.2–4.0

0.04

4.0–5.0

0.05

5.0–6.0

0.06

Item

Specification

Inner Diameter (ID)

0.1-2.2mm

Inner Diameter Tolerance

±0.01mm

Wall Thickness

0.015-0.20mm

Outer Diameter (OD)

0.13-2.4mm

Outer Diameter Tolerance

Wall Thickness 0.015-0.05mm: ±0.007mm

Wall Thickness 0.05-0.10mm: ±0.01mm

Wall Thickness 0.10-0.20mm: ±0.02mm

Length

0-2m

Concentricity

≥85%

Tensile Strength at Break

≥20000psi (138MPa)

Elongation at Break

≥30%

Color

Natural Color (Amber) / Customized

Biocompatibility

Compliant with USP CLASS VI

Inner Layer

Generally PTFE Etched Tube

Middle Layer - Coiling

Coiling Material: Stainless Steel 304 (Common), Nitinol, etc.

Or Middle Layer - Braided Wire

Braiding Spindle Count: 8 spindles, 16 spindles, 32 spindles

Braiding Method: 8 spindles (1-over-1), 16 spindles (1-over-1), 16 spindles (1-over-2), 16 spindles (2-over-2), 32 spindles (1-over-2), 32 spindles (2-over-2)

Outer Layer

PEBAX, TPU, PA with various durometers, multi-segment or single-segment outer tube

Radiopaque Ring

Material: Platinum-Iridium, Tantalum, Gold, etc.

Processable Capability Range

Size: 3F-36F

Length: 1750mm

Wall Thickness: Depends on Coiling/braided wire thickness; generally, the resin layer thickness outside Coiling/braided wire needs to be >0.08mm

Item

Details

Blue Steerable Injection Catheter

Outer Diameter: 4.3±0.05 mm

Outer Diameter of Small Lumen: 1.7±0.05 mm

White Injection Catheter

Inner Diameter: 2.8±0.05 mm

Outer Diameter: 4.0±0.05 mm