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304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling

304 Stainless Steel Medical Device Spare Parts with Biocompatibility Standards and High Precision CNC Milling

نام تجاری:	Yue lin sen
شماره مدل:	Y2662
مقدار تولیدی:	100 عدد
قیمت:	0.5-20
شرایط پرداخت:	T/T
توانایی عرضه:	5000000 عدد

اطلاعات دقیق

توضیحات محصول

اطلاعات دقیق

محل منبع:

گوانگدونگ

گواهی:

ISO9001 ISO13485

مدت پرداخت:

TT Westerm Union MomeyGram Paypal

سازگاری:

مطابق با استانداردهای زیست سازگاری

فرآیند:

ماشینکاری Cnc + برش

استاندارد:

قطعات غیر استاندارد

برنامه:

تجهیزات پزشکی، ابزار جراحی

بازرسی:

100٪ بازرسی ابعادی، گزارش های CMM

تحمل فرز CNC:

0.05 میلی متر پوند (0.002 ± ")

ضخامت دیوار:

0.1 میلی متر - 3.0 میلی متر

پایان:

بوی

سطح بندی:

Ra 0.8 - 1.6 میکرومتر

حرارت درمانی:

در صورت درخواست موجود است

اندازه:

نیاز مشتریان

فرایند ساخت:

ماشینکاری CNC، فرزکاری، تراشکاری

Sizerange:

اندازه های سفارشی موجود، معمولاً 1 میلی متر تا 300 میلی متر

زمان سررسید:

2 تا 6 هفته

جزئیات بسته بندی:

جعبه مقوایی بسته بندی وکیوم

برجسته کردن:

304 Stainless Steel Medical Device Spare Parts,Biocompatibility Standards CNC Milling Parts,High Precision CNC Milling Medical Machining Parts

Biocompatibility Standards CNC Milling Parts

High Precision CNC Milling Medical Machining Parts

توضیحات محصول

Our 304 Stainless Steel Medical Device Component CNC Milling service specializes in producing precision functional parts and accessories for medical equipment. Utilizing advanced Computer Numerical Control (CNC) milling technology, we create complex, high-tolerance components that meet stringent healthcare industry requirements. The resulting parts offer excellent corrosion resistance, durability, cleanability, and biocompatibility, making them suitable for both direct and indirect patient contact applications in diagnostic, therapeutic, and surgical devices.

Manufacturing Process

1. Design & Engineering Analysis: Review of customer CAD models with Design for Manufacturability (DFM) and medical device regulatory considerations.

2. Material Certification & Preparation: Sourcing of certified 304 stainless steel plate, bar, or block (ASTM A240) with full traceability. Precision cutting to size.

3. Multi-Axis CNC Milling: Machining on 3-axis, 4-axis, or 5-axis CNC milling centers to achieve complex geometries, thin walls, and intricate features.

4. Secondary Operations: Precision drilling, tapping, reaming, and boring to create holes, threads, and precise interfaces for assembly.

5. Deburring & Edge Radiusing: Comprehensive removal of all sharp edges and burrs—a critical safety step for medical components.

6. Surface Finishing:

Vibratory/Tumbling Finishing for initial smoothing
Electropolishing for smooth, clean, corrosion-resistant surfaces
Passivation to restore/enhance protective chromium oxide layer
Bead Blasting for uniform matte aesthetic

7. Intensive Cleaning: Multi-stage ultrasonic cleaning in validated processes to meet medical cleanliness standards.

8. Quality Inspection & Documentation: 100% dimensional inspection, visual inspection, and provision of material certificates and inspection reports.

9. Cleanroom Packaging: Packaging in controlled environments to prevent contamination.

Applications

Surgical Instrument Components: Housings, handles, triggers, guards, and internal mechanisms
Diagnostic & Monitoring Equipment: Housings, frames, brackets, sensor mounts, and covers
Medical Device Housings & Enclosures: Protective cases and structural shells
Dental Equipment Parts: Components for chairs, handpiece holders, and instrument trays
Hospital & Lab Furniture Components: Adjustable arms, rails, connectors, and supports
Sterilization & Processing Trays: Custom trays for organizing and sterilizing surgical instruments

Technical Specifications

Parameter Category	Specification	Details & Options
Material	Alloy	304 Stainless Steel (ASTM A240, UNS S30400). The most common stainless steel for general medical applications.
	Key Properties	Good corrosion resistance, high strength, good machinability, hygienic, non-magnetic in annealed state.
Machining Capabilities	CNC Equipment	3-axis, 4-axis, and 5-axis simultaneous machining centers.
	Positioning Accuracy	Up to ±0.005 mm
	Repeatability	Up to ±0.0025 mm
Geometric Capabilities	Minimum Feature Size	0.5 mm
	Minimum Wall Thickness	0.75 mm (stable), 0.5 mm (possible with careful design)
	Maximum Part Size	Up to 600 mm x 500 mm x 300 mm (machine dependent)
Tolerances	Standard Machining Tolerance	± 0.05 mm (ISO 2768-m)
	Precision Machining Tolerance	± 0.025 mm
	High-Precision Tolerance	± 0.0125 mm (for critical features)
Surface Finish (Ra)	As-Machined	1.6 μm - 3.2 μm
	Fine Machined	0.8 μm - 1.6 μm
	Electropolished	0.4 μm, 0.2 μm, <0.1 μm (Mirror) - Common medical finish
Post-Processing	Standard Finishes	Passivation (ASTM A967), Electropolishing, Bead Blasting
Biocompatibility & Cleanliness	Biocompatibility (ISO 10993)	Suitable for limited or prolonged skin contact, supports biological safety evaluation
	Cleanliness Standards	Can be cleaned and packaged to meet specific particle count and bioburden levels
Sterilization Compatibility	Method Compatibility	Autoclave (Steam), Ethylene Oxide (EtO), Gamma Radiation, Hydrogen Peroxide Plasma
Quality & Compliance	Quality Management System	ISO 13485:2016 certified manufacturing
	Inspection & Metrology	First Article Inspection (FAI), CMM reporting, material certification
	Traceability	Full material and process lot traceability
Production Scope	Prototyping & Low-Volume	Ideal for R&D, clinical trials, and pilot production
	Medium to High-Volume Production	Scalable production suitable for commercial device manufacturing
	Lead Times	Prototypes: 2-5 weeks; Production: 6-12 weeks
Design & Value-Added Services	Design for Manufacturing (DFM)	Expert analysis to optimize part design for cost, manufacturability, and performance
	Assembly & Kitting	Sub-assembly and full device assembly services available

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