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Stainless Steel Milling Flat Pin Shaft Precision Medical Hardware Components.
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Stainless Steel Milling Flat Pin Shaft Precision Medical Hardware Components.
| Place of Origin | GuangDong Dongguan |
| Brand Name | SITUO |
| Certification | ISO9001 & TS16949 |
| Model Number | ST-110008 |
Product Details
Material:
Stainless Steel
Category:
Axis Pin
Surface Treatment:
Passivation
Processing Technology:
CNC Turning
Sample Period:
10 To 15 Days
Precision:
Min0.001
Head Shape:
Communication
Countryoforigin:
China
Corrosionresistance:
Yes
Durability:
High
Productname:
Medical Hardware
Packing:
Carton
Weight:
Lightweight
Manufacturer:
SITUO
Our Service:
One-step Service
Usage:
Machine
Highlight:
stainless steel flat pin shaft
,milling flat pin shaft
,Lightweight Medical Hardware tolerance 0.02MM
Payment & Shipping Terms
Minimum Order Quantity
1PCS
Price
5-10 USD per item
Packaging Details
Communication
Delivery Time
Communication
Payment Terms
T/T
Supply Ability
10000PCS per day
Product Description
The stainless steel precision milling flat pin shaft is used for medical machinery components.
Knurled Long Screw Assemblies: Applications in Medical Industry (Product‑specific), Features & Export Standards by Country
1. Applications in the Medical Industry (Specific Products)
1.1 Life Support & Monitoring Equipment
Patient monitors / ECG machines: Knurled long screw assemblies (M2.5–M6) used for enclosure fastening, display bracket adjustment, and keypad panel fixation, providing stable, vibration-resistant threaded connections for repeated assembly and disassembly.
Ventilators / anesthesia machines: Knurled long screws for gas circuit modules, control panel mounting, and tubing bracket fixation, compatible with medical-grade PC/ABS materials, anti-loosening, corrosion-resistant and easy to clean and disinfect.
Infusion pumps / syringe pumps: Knurled long screw assemblies used in transmission mechanisms, housing assembly, and battery compartment locking, ensuring long-term operational stability and compliance with medical cleaning and sterilization requirements.
1.2 Surgical & Diagnostic Instruments
Endoscopes / laparoscopes: Precision knurled long screws (M1.6–M3) for handle assembly, housing connection, and optical component adjustment, with dimensional tolerance ±0.02 mm, suitable for repeated sterilization and aseptic environments.
Surgical instruments (forceps, scissors, scalpel handles): Knurled long screws for connecting plastic handles and metal components, featuring high‑grip knurling to prevent rotation and slippage, compatible with autoclave sterilization.
Ultrasound scanners: Knurled long screw assemblies for probe interfaces, control panel assembly, and support bracket fixation, ensuring reliable mechanical connection and good EMC performance.
1.3 Rehabilitation & Orthopedic Devices
Prosthetics / orthotics: Knurled long screws (M4–M8) for joint adjustment, brace assembly, and mechanism locking, lightweight, high‑strength, ergonomic and suitable for long-term wearing.
Wheelchairs / walkers: Knurled long screw assemblies for armrest, footrest and backrest adjustment, impact-resistant, anti-loosening, and suitable for frequent position changes.
1.4 Medical Consumables & Laboratory Equipment
Disposable syringes / blood collection needles: Micro knurled long screws for needle hub and plunger assembly, ensuring high assembly accuracy and operational safety.
Incubators / centrifuges: Knurled long screws for housing, door and rotor mounting, resistant to high and low temperatures, humidity and chemical disinfection.
2. Key Features of Medical‑Grade Knurled Long Screw Assemblies
2.1 Material Properties (Medical Requirements)
Material: Medical‑grade lead‑free brass or stainless steel, compliant with RoHS, REACH and FDA food‑contact standards, lead content ≤ 0.05%.
Biocompatibility: Tested and certified in accordance with ISO 10993 (cytotoxicity, irritation, sensitization), safe for direct or indirect contact with human tissue and body fluids.
Corrosion resistance: No rust or harmful precipitation in disinfection environments such as iodophor, alcohol and EO sterilization; salt spray test ≥ 48–1000 hours according to grade.
Material stability: Stable performance under repeated high-temperature sterilization and long-term use.
2.2 Structural & Processing Advantages
Knurling design: Straight knurling, diamond knurling or helical knurling provides high friction and anti‑slip performance, effectively preventing rotation and loosening during adjustment.
High precision: Thread tolerance 6H, dimensional tolerance ±0.02–0.05 mm, ensuring assembly consistency and interchangeability.
Surface treatment: Passivation, lead-free nickel plating or environmental passivation, free of harmful substances, meeting medical export requirements.
Mechanical performance: High tensile strength, excellent torque resistance and fatigue resistance, suitable for long-term dynamic use.
2.3 Medical Application Requirements
Cleanliness: Produced in Class 7–8 cleanrooms, free of burrs, oil stains and metal particles.
Sterilization compatibility: Resistant to autoclaving (121 °C / 0.1 MPa), ethylene oxide (EO) sterilization and low-temperature plasma sterilization.
Reliability: Stable performance after ≥ 100 assembly and adjustment cycles, designed for a service life of 5–10 years in medical devices.
3. Export Standards for Medical Hardware (by Major Markets)
3.1 Global General Standards
Quality management system: ISO 13485 (mandatory for medical devices worldwide).
Biocompatibility: ISO 10993 series (essential for patient-contact components).
Environment & hazardous substances:
- RoHS 2.0: Restrictions on Pb, Hg, Cd, Cr⁶⁺, PBB, PBDE.
- REACH: Compliance with SVHC list.
- Lead‑free requirement: Pb ≤ 0.05% for patient-contact parts (EU & FDA).
Traceability: UDI (Unique Device Identification), batch code, material, sterilization and certification marks.
3.2 European Union (EU)
Certification: CE marking under MDR 2017/745.
Standards: EN ISO 13485, EN ISO 10993, EN 14971 (risk management), EN 11135 (EO sterilization).
Registration: EUDAMED registration.
Material: Lead-free brass/stainless steel, heavy metal migration limits.
3.3 United States (US)
Regulation: FDA 510(k) clearance (Class II), PMA (Class III).
QMS: 21 CFR Part 820 (QSR 820).
Material: Compliant with FDA 21 CFR for food/medical contact.
US Agent: Required for non-US manufacturers.
3.4 Japan
Regulation: PMDA registration (Class I–IV).
Standards: JIS T series, ISO 13485, ISO 10993.
Environment: RoHS & lead-free compliant.
3.5 Other Major Markets
Canada: CMDCAS + Health Canada registration.
Australia: TGA registration.
ASEAN: AMDD certification.
Brazil: ANVISA certification.
China: NMPA registration, YY/T 0287 (ISO 13485), GB/T 16886 (ISO 10993).
3.6 Core Testing Items
Mechanical performance: Tensile strength, hardness, torque, pull-out force, cycle reliability.
Environmental testing: Salt spray, temperature cycling, humidity, sterilization resistance.
Chemical testing: Heavy metal leaching, RoHS/REACH compliance, lead-free verification.
Biological testing: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization).
4. Export Compliance Summary
Material priority: Medical‑grade lead-free brass or stainless steel, Pb ≤ 0.05%.
System foundation: ISO 13485 is mandatory globally.
Biocompatibility: ISO 10993 testing is critical.
Environment: RoHS, REACH, lead-free required worldwide.
Certification routes:
- EU: CE (MDR) + EUDAMED.
- US: FDA 510(k)/PMA + QSR 820.
- Japan: PMDA registration.
Labeling & traceability: Complete UDI, batch, material and certification information.
We have introduced advanced equipment and technology from Japan and Germany (CNC 5-axis and 6-axis machines) to better serve our customers' needs.
Our maximum processing outer diameter is 60, and the minimum control tolerance is 0.001. We have Japanese CNC Tsugami, CNC Citizen, multi-station cold extrusion forming machines, 500T press machines, casting equipment, and various process equipment, which can effectively provide customers with the best technical solutions.
Our company has a total of 300 employees, including 20 technicians, 10 engineers, and 15 quality control personnel. We have over 300 pieces of equipment.
Our company implements 8S management and has passed ISO9001 and TS16949 automotive certifications.
Our customers include Siemens, bo-sch, Foxconn, Panasonic Motors, Husqvarna, Shimano, NVIDIA, DJI Drones, Siegenia, and Cater-pillar.
| OUR CAPACITY | ||||
| Main product names: | Stainless steel screws, carbon steel screws, pins, rivets, nuts, | |||
| eccentric nails, embedded parts, and other fasteners. | ||||
| Business Type | Factory / Maufacture | |||
| Service | CNC Machining | |||
| Turning and Milling | ||||
| CNC Turning | ||||
| Cold heading | ||||
| stamping | ||||
| Assembly Service | ||||
| Material | 1). Aluminum: AL 6061-T6, 6063, 7075-T etc | |||
| 2). Stainless steel:303,304,304L,316L,316F,630,410,420,430, etc | ||||
| 3). Steel: 4140, Q235, Q345B,20#,45# 1215,12L14 ,1144,1006,1008,1010,1015,1018 ,10B21,1035,1065 etc. | ||||
| 4)Alloy steel:5140,4135,4140,3435,5120,415 ,435,440 etc | ||||
| 5). Titanium: TA1,TA2/GR2, TA4/GR5, TC4, TC18 etc | ||||
| 6). Brass: C36000 (HPb62), C37700 (HPb59), C26800 (H68), C22000(H90),C27000,C51900,C11000,C3604,H62,H65 etc | ||||
| 7). Copper, bronze, Magnesium alloy, Delrin, POM,Acrylic, PC, etc. | ||||
| Finish | Sandblasting, Anodize color, Blackenning, Zinc/Nickl Plating, Polish, | |||
| Power coating, Passivation PVD, Titanium Plating, Electrogalvanizing, | ||||
| electroplating chromium, electrophoresis, QPQ(Quench-Polish-Quench), | ||||
| Electro Polishing,Chrome Plating, Knurl, Laser etch Logo, etc. | ||||
| Drawing format | STEP,STP,GIS,CAD,PDF,DWG,DXF etc or samples. | |||
| Tolerance | +/-0.01mm ~ +/-0.05mm | |||
| Surface roughness | Ra 0.1~3.2 | |||
| Inspection | Complete inspection lab with Micrometer, Optical Comparator, Caliper Vernier,CMM | |||
| Depth Caliper Vernier, Universal Protractor, Clock Gauge, Internal Centigrade Gauge | ||||
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13925509630
No. 9, Shi bi One Alley, Zhangmutou Town, Dongguan City, Guangdong Province
