Chiba Needle Product Specifications, Material Selection & Customized OEM/ODM

How Manufacturers Meet Diverse Global Buyer Requirements

https://radiopaedia.org/articles/chiba-needle

As a typical "standard product + highly customizable" interventional consumable, the Chiba needle manufacturer must offer flexible configurations within a basic parameter framework to suit different regions and customer channels. Below are industry-common specifications and customization essentials:

Basic Specification Parameters

Gauge (Outer Diameter):​ Common 18G (≈1.27 mm), 19G, 20G (≈0.91 mm), 21G (≈0.82 mm), 22G (≈0.70 mm), 23G (≈0.64 mm); occasionally 15G–16G for special drainage. FNA typically uses 20G–23G; drainage/PTC commonly 18G–20G.

Effective Length:​ Standard 90 mm (3.5"), 150 mm (6"), 200 mm (8"); deep-seated lesions can be customized to 250 mm or 300 mm. Total length including hub typically adds 25–35 mm.

Tip Type:​ Standard short-bevel Chiba bevel, Quincke bevel, long bevel (Menghini style), Franseen tri-facet cutting tip, EcoChiba with echo-etching.

Surface Treatment:​ Electropolished inner lumen, passivated outer surface, tip sandblasting/laser-etched echo marker.

Scale & Depth Stop:​ No scale / cm markings + sliding depth stop / proximal cm mark only.

Stylet:​ With / without; flat tip or micro-chamfered tip.

Hub:​ Transparent Luer Slip, Luer Lock (color-coded per ISO 6009 - e.g., 22G = pink, 21G = dark green, 20G = yellow, 18G = pink; note regional惯例 variations, confirm with customer), winged thumb grip (Winged Hub), rotatable hub.

Packaging:​ Non-sterile bulk (reusable type - diminishing) or EO-sterilized individual paper-plastic pouch/blister, with lot number & expiry date; bulk box (10/20/50 pcs) or clinical small-box packing.

Material Selection

Cannula:​ SUS304 (cost-effective, satisfies most markets), SUS316L (superior corrosion resistance, preferred for European/Japanese high-end lines), Nitinol (NiTi) shape memory alloy rarely used for standard Chiba but possible for special flexible versions.

Hub:​ Medical ABS (rigid, low cost), PC (high transparency for visualizing blood/bile return), PP (flexible). Color coding per ISO 6009 or per customer specification.

Depth Stop / Protection Cap:​ PE, PP.

Hot OEM/ODM Customization Requests

Private-label buyers (international brands) often request: ① Specific Gauge × Length combinations not in standard catalog (e.g., 21G × 175 mm); ② Customer logo laser-marked on hub or tube near hub; ③ Proprietary color-coding system; ④ Ultrasound echo marker (sandblast or groove) with acoustic validation statement; ⑤ Special packaging (mixed-spec sets per box, with sample collection cards); ⑥ CE/FDA/NMPA registration dossier technical support (DHF/DMR compilation assistance). Manufacturers capable of full-link response - from drawing → prototype → pilot run → mass production - have a stronger advantage in securing orders.

Certification & Compliance

Export to EU requires CE Marking (under MDR, typically Class IIa/IIb depending on intended claims); US market usually via 510(k) or as a component supplied to a domestic distributor for registration; domestic China sales require NMPA Class III or II medical device registration certificate (most regions classify Chiba biopsy needles as Class III interventional devices). Manufacturers must be certified to ISO 13485:2016; some buyers additionally require ISO 9001 and periodic third-party audits.