Medical-Grade Helical Compression Spring with ISO 13485-Certified Materials, ±0.005mm Tolerances, and Biocompatibility Testing per ISO 10993
Medical-Grade Helical Compression Spring with ISO 13485-Certified Materials, ±0.005mm Tolerances, and Biocompatibility Testing per ISO 10993
Basic Properties
Place of Origin:
Sihong, China
Brand Name:
Sunzo
Certification:
CE/IATF16949/45001/14001/9001
Trading Properties
Minimum Order Quantity:
Negotiable
Price:
Negotiable
Payment Terms:
Negotiable
Product Summary
Medical-grade helical compression springs with ISO 13485 certification. Precision-engineered from biocompatible materials like 316LVM stainless steel & titanium. Cleanroom manufactured, sterilization validated, and backed by full documentation for healthcare applications.
Product Custom Attributes
Highlight
helical compression spring 20mm
Material:
ASTM F138 Titanium Alloy, 316LVM Stainless Steel
Surface Finish:
0.002μm
Wire Diameter:
0.15mm
Dimensional Tolerance:
±0.005mm
Force Output Tolerance:
±2%
Cycle Life:
10⁶ Cycles
Service Life:
5+ Years
Cleanroom Class:
ISO 7 Class 10,000
Sterilization Residual:
<25ppm
Gamma Irradiation:
25-40 KGy
Inspection Magnification:
50x
Load-Deflection Accuracy:
±0.01N
Ophthalmic Wire Diameter:
0.18mm
Pitch Precision:
0.003mm
MRI Compatibility:
<0.5 Tesla
Field Failure Rate:
<0.001%
Biocompatibility Testing:
ISO 10993-5, ISO 10993-10
Material Certification:
ISO 13485
Micro-Force Accuracy:
±0.01N
Temperature Stability:
Body Temperature Fluctuations
Product Description
Detailed Specifications & Features
Helical Compression Spring for Medical Equipment
Engineered Precision for Hygiene-Critical Healthcare Applications
In the medical device industry, compression springs serve as critical components where performance reliability and biocompatibility directly impact patient safety and clinical outcomes. Our Medical-Grade Helical Compression Springs are engineered to meet the stringent requirements of surgical instruments, diagnostic equipment, and implantable devices, delivering exceptional precision in environments where hygiene and mechanical stability are non-negotiable.
Material & Biocompatibility Standards
Crafted from ISO 13485-certified materials, including ASTM F138 titanium alloy (for implantable applications) and 316LVM stainless steel (with 0.002μm surface finish), our springs undergo rigorous biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) standards, ensuring zero leachable contaminants and minimal tissue reaction.
Precision Engineering
Our engineering process integrates advanced CAD (SolidWorks Medical) with finite element analysis (FEA) optimized for medical load profiles—simulating dynamic stress during surgical tool actuation or diagnostic equipment cycling. This precision engineering achieves dimensional tolerances of ±0.005mm for wire diameters as small as 0.15mm, critical for micro-surgical instruments like laparoscopes and endoscopes.
Performance Specifications
| Parameter | Specification |
|---|---|
| Force Output Tolerance | ±2% across 10⁶ cycles |
| Service Life | 5+ years for implantable devices |
| Wire Diameter Range | As small as 0.15mm |
| Dimensional Tolerance | ±0.005mm |
Manufacturing & Quality Control
Manufacturing adheres to cleanroom protocols (ISO 7 Class 10,000) with automated handling to prevent particulate contamination. Post-production sterilization validation includes ethylene oxide (EO) processing with residual levels <25ppm and gamma irradiation (25-40 kGy) for single-use devices. Each spring undergoes 100% visual inspection under 50x magnification and load-deflection testing using micro-force transducers with ±0.01N accuracy.
Application-Specific Solutions
- Ophthalmic surgical tools: 0.18mm wire diameter springs with 0.003mm pitch precision for micro-incision procedures
- Diagnostic analyzers: Anti-magnetic stainless steel springs with MRI compatibility (<0.5 Tesla magnetic susceptibility)
- Trauma fixation devices: Nitinol shape-memory springs that maintain force under body temperature fluctuations
Certification & Documentation
Backed by a dedicated medical R&D team with 20+ years of FDA 510(k) submission experience, we provide full documentation packages including material certificates (3.1.B), process validation reports, and sterility assurance documentation. Our springs currently support 40+ Class III medical devices globally, with a field failure rate of <0.001%—underscoring our commitment to advancing healthcare through precision engineering.
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