ISO13485 Certified Biocompatible Material Disposable Medical Syringe Barrel And Accessories Injection Mold

Precision injection-molded medical components refer to high-accuracy plastic parts tailored for healthcare scenarios (diagnostics, surgery, treatment, etc.). They are critical for medical device functionality, safety, and patient compatibility, with strict requirements for dimensional precision, biocompatibility, and regulatory compliance.

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Brand:
YIXUN mold
Code:
8480419090

Product Description

Product Overview

This medical injection mold is specially customized for mass production of disposable plastic syringes in multiple specifications, including syringe barrels, protective caps, connecting tubes and other medical syringe accessories. Manufactured strictly under the ISO13485 medical quality management system, the mold adopts high-polish medical-grade mold steel, multi-cavity balanced layout and precision exhaust design, which can produce syringes of various capacities ranging from small-dose to large-dose irrigation syringes. It fully meets the clean production requirements of medical consumables, ensures no burrs, no flash, high dimensional consistency and excellent surface smoothness for syringe products, widely applied in clinical injection, wound irrigation, laboratory sampling, veterinary medicine and home healthcare fields. We provide one-stop medical mold services including mold flow analysis, precision CNC machining, cleanroom assembly, multi-round mold trials and global after-sales technical guidance.

Core Advantages of Medical Syringe Injection Mold

1. ISO13485 Standard Medical Grade Manufacturing

The whole mold design, processing, assembly and testing are implemented in accordance with ISO13485 medical device quality management norms:

Complete traceable quality documents including material certificates, heat treatment reports, dimensional inspection records and mold validation files, supporting customers' medical product registration and factory audit
Mold structure optimized with no dead corners, easy to clean and disinfect, effectively avoiding particle pollution and bacterial residue
Strict anti-rust and dust-proof packaging to prevent mold contamination during international transportation, guaranteeing clean production conditions for medical consumables

2. High Mirror Polished Cavity for Flawless Medical Plastic Surface

Core and cavity adopt high-precision mirror polishing treatment:

Ultra-smooth inner surface ensures clear, precise scale printing on syringe barrels without flow marks, air bubbles or haze defects
Effectively avoids burrs and sharp edges, complying with medical safety requirements to prevent skin puncture during clinical use
Low surface adhesion prevents plastic residue accumulation, supporting frequent material switching and color batch production without cross-contamination
Ensures tight assembly matching among syringe barrel, plunger and protective cap to avoid liquid leakage

3. Multi-Cavity Balanced Runner System for High-Yield Mass Production

Customizable multi-cavity symmetrical layout (6/8/12/16 cavities optional), one injection cycle can produce multiple syringe parts simultaneously, greatly improving hourly output and reducing unit production cost
Balanced cold runner or hot runner optional design realizes uniform melt filling, guarantees consistent dimensional tolerance of each syringe product
Precision dense exhaust slots arranged along the parting line to thoroughly eliminate trapped air, effectively solve common defects such as product burning, short shot and weld lines of medical PP raw material
Optimized circulating cooling channel shortens molding cycle, realizing high-speed automatic continuous production to meet huge demand for disposable medical syringes

4. Durable Medical Mold Steel with Stable Long Service Life

Select pre-hardened anti-corrosion medical mold steel (such as S136H / 718H) with hardness ranging from HRC 32-48:

Excellent corrosion resistance, suitable for long-term production of medical-grade PP, COP, COC and other transparent medical raw materials
Superior wear resistance and dimensional stability, effectively ensures the precision of syringe scale and assembly tolerance under millions of shots
Fine internal metallurgical structure supports repeated high-gloss polishing and mold maintenance, standard service life reaches 800,000 – 1,500,000 shots

Application Scope

Disposable medical injection syringes (1ml, 2ml, 5ml, 10ml, 20ml, 50ml and other conventional specifications)
Large-capacity irrigation syringes, feeding syringes, veterinary syringes
Syringe supporting accessories: needle protective caps, connecting tubes, syringe plungers, sealing sleeves
Laboratory sampling plastic syringes, cosmetic filling disposable syringes
Other medical transparent precision disposable plastic consumables

Detailed Technical Parameters

Item	Specification
Mold Product	Disposable Medical Syringe & Accessories Injection Mold
Quality Certification	ISO13485 Medical Quality Management System Certified
Optional Cavity Number	6 Cavity / 8 Cavity / 12 Cavity / 16 Cavity Customizable
Recommended Raw Material	Medical Grade PP, COP, COC
Mold Steel Option	S136H / 718H Pre-hardened Anti-corrosion Mold Steel
Hardness Range	HRC 32 – 48
Cavity Surface Treatment	High Gloss Mirror Medical Polishing
Runner System	Cold Runner / Hot Runner Customizable
Estimated Mold Lifespan	800,000 – 1,500,000 Shots
Applicable Equipment	160T – 450T Horizontal Injection Molding Machine

Our Professional Medical Mold Customization Service

Medical Mold Flow Simulation: We conduct professional mold flow analysis aiming at medical thin-wall syringe products to optimize gating, cooling and exhaust structure, effectively prevent warpage, leakage and scale deviation defects.
Strict Cleanroom Assembly & Pre-delivery Test: All mold assembly and trial production are finished in clean workshop; we provide free syringe samples and complete quality certification documents for customer confirmation.
Global Remote Technical Support: Offer online mold installation guidance, medical PP injection parameter debugging, mold anti-rust maintenance training and lifelong technical consultation service.
Full OEM & ODM Customization: Support custom syringe capacity, Luer lock / Luer slip structure, scale design, anti-slip structure, disposable safety syringe structural development and mold modification.

FAQ

1. Why is ISO13485 certification essential for medical syringe molds?

ISO13485 is the global unified quality management standard for medical device production. Molds manufactured under this system can provide complete process traceability documents, which is a necessary qualification for customers to complete medical device registration, factory inspection and international market sales.

2. Which mold steel is most suitable for transparent medical syringe molds?

S136H stainless mold steel is the preferred choice for syringe molds. It features excellent anti-rust, anti-corrosion performance and ultra-high mirror polishing performance, which can perfectly ensure the high transparency of medical PP syringe barrels and extend the service life of the mold.

3. Can one set of mold produce multiple different capacity syringes?

We can design an interchangeable insert structure for you. By replacing different mold inserts on the same mold base, you can produce syringes of multiple specifications, which can greatly save your secondary mold development cost and factory equipment investment.

4. What is the usual production lead time for a multi-cavity syringe mold?

For conventional 8-cavity medical syringe barrel mold, the production cycle is 35~45 working days, including raw material heat treatment, precision polishing, clean assembly and multiple rounds of mold trial verification. The exact delivery schedule will be confirmed in the formal order contract.

Medical Syringe Barrel And Accessories Injection Mold ISO13485 Certified Biocompatible Material medical mold disposable medical syringe mold