[email protected] ISO Class 8 Clean Room ISO13485 medical products quality management certificate

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iso 13485 compliant customized medical grade plastic injection services custom face shield visor top frame injection mould-0

Medical Components

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ISO 13485 Compliant Customized Medical Grade Plastic Injection Services Custom Face Shield Visor Top Frame Injection Mould

  • Description
  • Specifications
  • Applications
  • Advantages
  • Recommended Products

Description

Our ISO 13485 Compliant Customized Medical Grade Plastic Injection Services offer turn-key solutions for high-precision medical device component manufacturing. Specializing in the engineering and production of the Custom Face Shield Visor Top Frame Injection Mould, we ensure that every tool is built to withstand rigorous, high-volume production while maintaining strict medical-grade cleanliness and structural integrity.

Specifications

Product Name ISO 13485 Compliant Customized Medical Grade Plastic Injection Services Custom Face Shield Visor Top Frame Injection Mould
Model Number 25223
Mould Base LKM
Mould Material H13 HRC48-52
Mold Precision +/-0.01mm
Mould Life 1 million shots
Mould Cavity Single cavity
Runner System cold/hot runner
Equipment High speed CNC, Standard CNC, EDM, Wire Cutting, WEDM, Grinder, Plastic Injection Molding Machine from 50-818T available.
Plastic Material ABS
Metal Material Heat treatment steel
Surface Treatment Polishing
Pls Provide 2D/3D drawing, samples
Quality System

ISO 9001: 2015

ISO 13485

Applications

Medical & Hospital PPE:

Heavy-duty, reusable or disposable face shield headbands and visor frames worn by frontline healthcare workers, surgeons, and nurses.

Dental Clinics: Lightweight, comfortable protective face shield frames for dentists, hygienists, and orthodontic technicians.

Laboratory & Research Facilities: Chemical-resistant and autoclave-compatible visor frames for scientists handling hazardous or bio-hazardous materials.

Industrial Cleanroom Environments: Safety visors utilized in pharmaceutical manufacturing, semiconductor fabrication, and electronics assembly lines.

Advantages

Strict ISO 13485 & Cleanroom Compliance:

Manufactured under a strict ISO 13485 medical quality management system. We offer the option for both tooling validation and parts production inside a Class 100,000 (ISO Class 8) cleanroom, ensuring the final plastic visor frames are completely free from dust, oil, and biological contaminants.

Medical-Grade Material Optimization:

The mold is optimized to run premium medical-grade plastics (such as Medical PP, PC, ABS, or PETG) that are highly resistant to chemical disinfectant wiping, UV sterilization, and repeatable autoclave cycles without degrading or warping.

Extended Mold Lifespan (Premium Tooling Steel):

By utilizing top-tier, corrosion-resistant steels like hardened S136 or NAK80, we guarantee a mold life of 500,000 to 1,000,000+ shots, providing an exceptionally low cost-per-case over the lifecycle of your medical project.

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