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Telefoonnummer : +86 18965147291
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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
Plaats van herkomst Xiamen, Fujian, China
Merknaam Creator
Certificering ISO 9001:2015
Modelnummer KD-MED-SIL-001
Min. bestelaantal 100 stuks
Prijs negotiable
Verpakking Details Exportkarton met PE-zak, gepalletiseerd voor containerverzending
Levertijd 25-35 werkdagen voor nieuwe mal, 7-15 dagen voor productie
Betalingscondities T/T, L/C, PayPal, Western Union
Levering vermogen 100.000 stuks per maand
Productdetails
Materiaal LSR van medische kwaliteit Certificering ISO 13485:2016
Sterilisatie EtO, Gamma, Autoclaaf
Markeren

ISO 13485 Certified Injection Molding Service

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Biocompatible LSR Molding

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Sterilization-Compatible Medical Silicone Molding
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Productomschrijving

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.

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