MachineU > China Products > Fabrication Services > Moulds
ISO 13485 Certified Biocompatible LSR Injection Molding Service for Sterilization-Compatible Medical Components
ISO 13485 Certified Biocompatible LSR Injection Molding Service for Sterilization-Compatible Medical Components
Specifications
Brand Name :
Creator
Model Number :
KD-MED-SIL-001
Place of Origin :
Xiamen, Fujian, China
Certification :
ISO 13485:2016
MOQ :
100 Pieces
Price :
Negotiation
Payment Terms :
T/T, L/C, PayPal, Western Union
Supply Ability :
100000 Pieces per Month
Delivery Time :
25-35 working days for new mold, 7-15 days for production
Packaging Details :
Export-grade carton with PE bag, palletized for container shipment
Material :
Medical-grade LSR
Sterilization :
EtO, Gamma, Autoclave
Description

Medical Grade Silicone Injection Molding Service for Surgical Instrument Handles ISO 13485 Cleanroom

Xiamen Creator Technology Co., Ltd. provides ISO 13485 certified medical-grade silicone injection molding for surgical instrument handles, grips, and medical device components. Our liquid silicone rubber (LSR) molding process in an ISO Class 8 cleanroom ensures biocompatible, sterilizable components meeting the most stringent medical industry requirements.

Key Features & Advantages

  • ISO 13485:2016 certified medical device component manufacturing
  • Liquid Silicone Rubber (LSR) injection molding in ISO Class 8 cleanroom
  • Biocompatible materials per ISO 10993 standards
  • Sterilization-compatible: EtO, Gamma irradiation, Steam autoclave
  • Overmolding capability for soft-touch surgical instrument grips
  • Full traceability with device history records and material certifications

Technical Specifications

CertificationISO 13485:2016, ISO 9001:2015
MaterialMedical-grade LSR, Solid Silicone, TPE
Cleanroom ClassISO Class 8 (100,000)
Mold MaterialS136 Stainless Steel, NAK80
Mold Precision±0.01mm
SterilizationEtO, Gamma, Autoclave Compatible
Durometer Range20 - 80 Shore A
Lead Time30-40 working days

Manufacturing Excellence

Our dedicated medical molding facility features an ISO Class 8 cleanroom with HEPA filtration and positive pressure control. We utilize advanced LSR injection molding machines with precise temperature and pressure control for consistent silicone part quality. Every production lot undergoes rigorous inspection and is accompanied by complete device history records including material certifications, process parameters, and final QC reports.

Frequently Asked Questions

Q: Are your silicone materials medical grade?

A: Yes. We use medical-grade LSR and solid silicone materials that are biocompatible per ISO 10993 and suitable for surgical instrument applications.

Q: Can you produce overmolded surgical grips?

A: Yes. We offer LSR overmolding onto plastic or metal substrates for soft-touch surgical instrument handles with excellent chemical resistance.

Q: What sterilization methods are compatible?

A: Our silicone components are compatible with EtO gas, Gamma irradiation, and steam autoclave sterilization methods.

Q: Do you provide biocompatibility test reports?

A: We can provide material biocompatibility documentation from our raw material suppliers and coordinate additional testing through certified labs when needed.

Send your message to this supplier
Send Now

ISO 13485 Certified Biocompatible LSR Injection Molding Service for Sterilization-Compatible Medical Components

Ask Latest Price
Product Detail
Brand Name :
Creator
Model Number :
KD-MED-SIL-001
Place of Origin :
Xiamen, Fujian, China
Certification :
ISO 13485:2016
MOQ :
100 Pieces
Price :
Negotiation
Contact Supplier
ISO 13485 Certified Biocompatible LSR Injection Molding Service for Sterilization-Compatible Medical Components

Xiamen Creator Technology

Verified Supplier
7 Years
fujian, xiamen
Since 2007
Business Type :
Manufacturer, Exporter, Trading Company, Seller
Main Products :
Injection Molding Services, Plastic Injection Molding Service, Dual Shot Injection Molding
Total Annual :
2000000-3000000
Employee Number :
40~50
Certification Level :
Verified Supplier
Discover similar products
View More

Find Similar Products By Category:

Supplier Homepage Products Injection Molding Services
MachineU China Products Fabrication Services Moulds
Contact Supplier
Submit Requirement