Medical-grade CNC Components

Sanluo Precision is a professional manufacturer and supplier of medical-grade CNC components in China. Specializing in the precision manufacturing of CNC components, we adhere to the highest standards of the medical industry in production and quality control, providing customized machining services that exceed standards and supporting the customization of complex and challenging parts. We understand that medical-grade represents higher material standards, higher machining precision, and more comprehensive quality traceability; therefore, every medical-grade CNC component is a vital product related to patient safety.

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Product Description

Medical-Grade Material Control

Sanluo Precision uses medically certified materials for its medical-grade CNC components. Metal materials include 316L stainless steel (ASTM F138/F139), titanium alloy Ti6Al4V ELI (ASTM F136), and cobalt-chromium alloy (ASTM F75), all accompanied by material certificates and chemical composition reports. Engineering plastics such as PEEK (ISO 10993), PPSU, and PEI have all passed biocompatibility evaluations. Material suppliers should be ISO 13485 certified, and a list of qualified suppliers is maintained. Each batch of materials undergoes ICP spectroscopy to determine chemical composition, DSC thermal analysis to test material properties, and ultrasonic testing to eliminate internal defects. Material batches and product batches are matched one-to-one for full traceability.

Medical-Grade Processing Environment

Sanluo Precision is a company specializing in the manufacture of medical-grade CNC components and has a GMP-certified processing workshop. Achieving ISO Class 7 (Class 10000) standards, with particulate matter concentration <3.52 million/m³ (≥0.5μm). Company staff must wear cleanroom suits, change clothes, wash hands, and undergo air showers before entering the workshop. Daily cleaning and disinfection are conducted, along with monthly environmental monitoring (airborne and settling bacteria) to ensure a medical-grade environment.

Medical-Grade Testing and Certification

Sanluo Precision's factory conducts full inspection and certification for all medical-grade CNC components. Dimensional inspection uses CMM coordinate measuring machines, optical imaging systems, and laser scanners; inspection reports comply with ASME Y14.5 standards. Surface quality is tested using roughness testers, profilometers, and white light interferometers, meeting ISO 4287 standards. Material testing includes ICP spectroscopy, SEM/EDS, and XRD diffraction; material composition and microstructure comply with ASTM standards. Biocompatibility is assessed for cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10). We provide complete test reports and Certificates of Conformity (CoC). We have already provided customized medical-grade CNC machining services for pacemakers, intraocular lenses, and other devices.

Workstation Accuracy

dimensional accuracy	OD	ID	T（C）	DP	GD
unit:±/mm	0.002	0.003	0.005	0.005	0.005
Geometric accuracy	roundness	coaxiality	straightness	cylindricity	Position tolerance
unit:±/mm	0.001	0.004	0.002	0.003	0.008
production capacity	1~999999 pcs	1~999999 pcs	1~999999 pcs	1~999999 pcs	1~999999 pcs
production cycle	3-20 days	3-20 days	3-20 days	3-20 days	3-20 days

Processing equipment technical parameters

Parameter Category	Specifications
Equipment Model	Tsugami S205A Swiss-type Lathe (with optional high-frequency milling)
Core Positioning	Specialized for precision machining of small shaft parts such as stainless steel and titanium alloy bone screws and dental staples in the medical industry.
High-Frequency Milling Attachments	Can be equipped with a Japanese NAKANISHI BM-320F high-frequency milling machine, with speeds up to 80,000 rpm and a runout accuracy of 1μm.
High-Frequency Milling Dimensions	20mm outer diameter, 87mm length, can be directly installed in the tool holder hole of the Tsugami S205A.
Machining Function	Used for high-precision milling of titanium alloy bone screw end faces, such as "torch" milling (e.g., internal hexagonal, TORX®), requiring burr-free machining.
Core Advantages	The Swiss-type lathe itself is suitable for continuous machining of slender shaft parts; with the addition of a high-frequency milling machine, all processes can be completed on the same machine tool, ensuring consistent precision.
Typical Applications	Titanium alloy bone screws, bone screws, dental staples, and other medical-grade CNC components.

Parameter Category	Specifications
Equipment Model	SZ-20E2
Core Positioning	High-rigidity, high-stability 3-axis heavy-duty Swiss-type lathe
Number of Axes	3-Axis
Spindle System	Built-in oil-cooled electric spindle; speed: 10,000 / 12,000 rpm
Machining Capacity	Maximum machining diameter: Ø20 mm; with and without guide bushing are interchangeable.
Tooling System	Abundant blade structure
Core Advantages	The high rigidity design is suitable for heavy machining; it is especially suitable for high-precision shaft components.
Typical Applications	Precision shaft parts for industries such as 5G/3C, electronic connectors, medical-grade CNC components, and measuring probes.