Harnais de câbles pour dispositifs médicaux

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Harnais de câbles pour dispositifs médicaux

Harnais de câbles pour dispositifs médicaux

Precision & Compliance for Critical Healthcare Applications
Key Features:

Medical-Grade Materials: ISO 13485 & ISO 10993 compliant; resistant to sterilization (ETO, gamma, autoclave).
Noise-Free Signals: Shielded designs for sensitive equipment (MRI, patient monitors, surgical tools).
Custom Configurations: Tailored lengths, connectors (e.g., Amphenol), and color coding for traceability.

Why Choose Us?

Reliable OEM/ODM solutions for FDA/CE-approved devices—fault-free performance saves lives.

Spécifications

Conductors

High-purity oxygen-free copper (OFC) for consistent signal transmission

Stranded 32-24 AWG options for balance of flexibility and current capacity

Separator

Individual foil shielding for each conductor pair

Medical-grade PTFE inter-pair insulation

Voltage Rating

300V AC/DC (UL/CSA rated)

Withstands 1500V dielectric test

Insulation & Jacket Materials

USP Class VI compliant silicone/PUR compounds

Gamma radiation-resistant materials (up to 50kGy)

Key Features

Oxygen-free copper for stable ECG/signal transmission

USP Class VI compliant insulation

Resistance Properties

100MΩ insulation resistance

IP68 sealed connectors available

Temperature Range

-60°C to +200°C continuous operation

Autoclavable versions (134°C steam sterilization)

Industry Approvals

Key Approvals:
✅ ISO 13485 – Medical device quality management system certified
✅ ISO 10993 – Biocompatibility tested for patient contact applications
✅ USP Class VI – Meets pharmaceutical-grade material standards
✅ FDA 21 CFR 177.2600 – Compliant for repeated sterilization (ETO/autoclave)
✅ CE Medical Directive (93/42/EEC) – EU market approval

Why It Matters:
• Accelerates FDA/CE submission for your medical devices
• Guarantees performance in sterilization cycles
• Reduces biological contamination risks

Medical Device Wire Harness Specifications

Conductor	Insulation	Max Resistance (Ω/km, 20°C)	Dielectric Strength (VAC, 1min)
Size (AWG): 32-24	Material: Medical-grade silicone
Construction:	Thickness: 0.3-0.5mm
19/0.08mm (32AWG)	O.D: 1.2-2.1mm	≤550 (24AWG)	1500V (300V rated)
19/0.16mm (24AWG)	Color: Blue/White/Red	≤85 (24AWG)	3000V hi-pot test

Jacket Colors

Red (critical circuit identification)

Royal Blue (ISO 15223 medical device marking)

Yellow (critical circuit identification)

Clinical White (most common for cleanrooms)

Marking Options

Quick Print®

Surface Print

Indent Print

Logo / Icons / Branding

Sequential Marking

Produits apparentés

UL4348 Halogen-Free Wires

UL4348 Specifications Sheet Pitch (mm) Conductor Insulation Resistance At 20C Ω/km Dielectric Strength (Vac,1min) Size (AWG) Construction (No/mm) Dia. (mm) (No.) Thickness (mm) O.D (mm)

Harnais sur mesure supportant la certification ULVDE

Harnais de câbles sur mesure avec certification UL/VDE - Conception de précision pour une conformité globale

Solutions personnalisées en matière de faisceaux de câbles

Custom Wire Harness Solutions - Wire Specification Table Conductor Insulation Max Resistance (Ω/km, 20°C) Dielectric Strength (VAC, 1min) Size (AWG) : Sur mesure (40-4/0) Matériau : Silicone, PVC, TPE, XLPE,

Faisceau de câbles standard pour l'automobile

Faisceaux de câbles standard pour l'automobile Spécifications Conducteur Isolation Résistance maximale (Ω/km, 20°C) Rigidité diélectrique (VAC, 1min) Taille (AWG) : 8-20 Matériau : XLPE Construction : Épaisseur : 0,6-1,0 mm 133/0,3 mm (8AWG) Diamètre extérieur : 4,5-8,2 mm ≤2,1 (8AWG)

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