Our comprehensive inspection and quality control system ensures full compliance with ISO 13485, delivering reliable, traceable quality for every orthopedic component.

Inspection & Quality Control

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Calipers

Linear Dimension Measurement

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2D Projector

2D Profile Inspection

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CMM

3D Geometric Measurement

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Micrometer

Micro-Dimension Measurement

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Metal Composition Analyzer

Material Composition Analysis

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Hardness Tester

Hardness Testing

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Height Gauge

Height & Step Measurement

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Color Difference Meter

Color Uniformity Check

Technical Specifications

1. Dimensional & Geometric Inspection

Process Introduction

Precise measurement of dimensional tolerances, geometric dimensions and positional accuracy to ensure orthopedic implants and instruments meet strict clinical and engineering requirements.

Included Equipment

· 2D Projector

· CMM (Coordinate Measuring Machine)

· Micrometer

· Height Gauge

· Calipers

Technical Specifications

Machine Type
Max. Workpiece Size (mm)
Spindle Speed
Control System 
2D Projector
±0.001 mm
2D Profile & Dimension
0-300 mm
3D Geometric Tolerance
CMM
±0.002 mm
0–500 mm
Micro-Dimension
Micrometer
±0.001 mm
0–25 mm / 25–50 mm
Height & Step
Height Gauge
±0.002 mm
0–300 mm
Linear Dimension
Calipers
±0.01 mm
0–150 mm / 0–300 mm

2. Material & Composition Analysis

Process Introduction

Accurate identification and verification of medical-grade material composition to ensure biocompatibility and mechanical performance of orthopedic components, complying with ISO 13485 requirements.

Included Equipment

· Metal Composition Analyzer

Technical Specifications

Parameter
Specification
Mg–U (periodic table elements)
±0.01%
Detection Range
10–30 seconds per sample
Accuracy
Analysis Time

3. Surface & Coating Quality Inspection

Process Introduction

Comprehensive evaluation of surface roughness, coating thickness, color uniformity and adhesion to meet the surface quality requirements of orthopedic implants and instruments.

Included Equipment

· Color Difference Meter

· Surface Profilometer (supplementary for post-finishing validation)

Technical Specifications

Inspection Item
0.1–100 μm
Ra 0.025–10 μm
Surface Roughness (Ra)
Coating Thickness Gauge
Surface Profilometer
Coating Thickness
Equipment
Specification
Color Uniformity
Color Difference Meter
ΔE ≤ 1.0
Coating Adhesion
Scratch Tester
≥30 MPa

4. Hardness & Mechanical Property Testing

Process Introduction

Measurement of material hardness and mechanical properties to ensure the durability and reliability of orthopedic implants and instruments under clinical load conditions.

Included Equipment

· Hardness Tester

Technical Specifications

Test Type
Hardness Range
HRC 20–70
HV 100–1000
Rockwell Hardness
HB 100–500
Vickers Hardness
Brinell Hardness
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Orthopedic Precision Inspection

Core Inspection Advantages

· ISO 13485 certified quality management system for orthopedic medical device inspection

· High-precision measurement with tolerance control down to ±0.001 mm

· Full traceability of inspection data from raw material to finished product

· Professional inspection team with deep expertise in orthopedic device standards· 

Get A Quote

If you have requirements for precision machining, prototyping or small batch production of orthopedic implants and instruments, please feel free to send us your drawings and specifications.We will provide you with a professional quotation and solution within 24 hours.

CONTACT US

Tel: +86 18718750572

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Email: enquiry@honlike.com.cn

WhatsApp: +86 18718750572

101-103, Building 8, Bay Area Intelligence Valley, West District, Zhongshan, 528411, GuangDong, China

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