Breast Biopsy Needle
Product Overview
Our precision metal round bar/pin is engineered for surgical tool processing, complying with ISO 13485:2016. Made of biocompatible, high-strength metals, it features ultra-high precision, smooth surface and excellent machinability, suitable for orthopedic tools like Kirschner wires. We offer customization, strict QC and reliable supply.
Core Advantages
1. Medical-Grade Precision & Quality
• Tolerance: ±0.001mm (H7-H8), out-of-roundness ≤ 2/3 of diameter tolerance, straightness 0.2mm/m, ensuring seamless assembly.
• Surface Finish: Ra ≤ 0.2μm, no burrs/scratches, ensuring surgical safety via advanced grinding and polishing.
• QC: 100% full inspection with CMM/3D scanners, providing material traceability and inspection reports.
2. Medical-Grade Material Selection
Biocompatible materials available:
• Stainless Steel (304/316/316L): Corrosion-resistant, cost-effective for external fixation tools.
• Titanium Alloy (Ti6Al4V): Excellent biocompatibility, no MRI artifacts, for long-term implantation.
• Custom materials: Based on your biocompatibility/strength requirements.
3. Compliance & Certification
Complies with ISO 13485:2016, FDA 21 CFR Part 820, EU MDR. Relevant certificates/test reports available.
4. Customization Capability
Full customization options:
• Size: Diameter 0.6-40mm, (cuttable to any length).
• Surface treatment: Polishing, passivation, anodizing (customizable).
• Process: CNC turning/milling/grinding, micro-machining.
Material
. ASTM440PH . Type 440C
. UNS S44004PH . ASTM F899 ：
(Ultra-high rust-proof stainless steel AA) (hardened HRC54 ° ± 2 ° Section)
Ultra-high anti-rust & high wear-resistant , high hardness, high impact, high toughness stainless steel, with excellent anti-rust capability, corrosion resistance, wear resistance (high hardness) performance and ideal impact resistance.. Its excellent corrosion resistance is comparable to TYPE 304 Stainless steel; and its rust resistance is closer to alloy for surgical implant. Unmarked, with 5% Neutral salt spray test (ASTM B117), it doesn't rust after 1000 hours. Wide range of applications, quite good and stable quality, which can be used to produce extremely complex, high-precision shank shapes and profile ultra-sharp edge structures.
Applied for high-end medical standard: AMS 5936 . MMPDS-01 . ASTM A693
ASTM A564 . ASTM F899-12
The Vitro (cytotoxicity) test verifies that the material does not have any potential cytotoxicity and therefore can safely contact human tissue, body fluids or blood, and meets all relevant allergy and skin irritation test standards.
