Vinyl Terminated Silicone Fluid
Vinyl Terminated Silicone Fluid

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Essential Certifications for Vinyl Terminated Silicone Fluid Production

Vinyl Terminated Silicone Fluids are critical components in industries ranging from medical devices to industrial lubrication. To ensure product safety, regulatory compliance, and performance reliability, manufacturers must adhere to stringent quality certifications. Below is a comprehensive breakdown of the essential certifications required for producing high-performance Vinyl Terminated Silicone Fluids, along with insights into how leading suppliers like ​Biyuan​ meet these standards.


1. Core Regulatory Certifications

FDA Compliance (21 CFR Part 177.2600)​

FDA certification is mandatory for silicone fluids intended for food contact or medical applications. This certification confirms that the material meets strict safety standards for chemical inertness, non-toxicity, and migration resistance. For instance, Biyuan’s Vinyl Terminated Silicone Fluids undergo rigorous FDA audits to ensure compatibility with food processing equipment and pharmaceutical applications.

CE Marking (EU Directive 2015/844)​

In the European market, CE marking validates compliance with health, safety, and environmental regulations. Silicone fluids used in automotive or industrial systems must pass CE requirements for chemical stability and thermal performance. Biyuan’s products are engineered to exceed these benchmarks, ensuring seamless integration into EU-based manufacturing workflows.

REACH Compliance (EC No 1907/2006)​

REACH certification ensures that silicone fluids do not contain restricted substances like phthalates or heavy metals. Manufacturers must submit detailed chemical substance declarations and compliance reports. Biyuan’s supply chain maintains full REACH compliance through rigorous raw material screening and third-party testing.


2. Industry-Specific Certifications

ISO 9001: Quality Management Systems

ISO 9001 certification guarantees standardized production processes, consistent quality control, and traceability. For Silicone Fluids, this includes precise control over viscosity, volatility, and curing characteristics. Biyuan’s ISO-certified facilities utilize advanced analytical tools like FTIR and GC-MS to validate material properties.

ISO 13485: Medical Device Quality Systems

Medical-grade Silicone Fluids require ISO 13485 certification to meet biocompatibility and sterility standards. Biyuan’s medical-grade products undergo USP Class VI biocompatibility testing and are validated for use in surgical instruments and implantable devices.

USP Class VI (United States Pharmacopeia)​

This certification is critical for pharmaceutical and healthcare applications. USP Class VI testing evaluates cytotoxicity, sensitization, and hemocompatibility. Biyuan’s Silicone Fluids are engineered to pass these stringent tests, ensuring safety in contact with human tissues.


3. Material and Process Compliance

ASTM D2000 (Standard Classification of Silicone Rubber)​

ASTM D2000 outlines requirements for silicone materials based on mechanical and thermal properties. Vinyl Terminated Silicone Fluids must meet criteria for heat resistance (-60°C to +230°C) and chemical inertness. Biyuan’s formulations are optimized to exceed ASTM standards, particularly in high-shear applications like hydraulic systems.

RoHS Directive (2011/65/EU)​

RoHS compliance ensures the absence of hazardous substances like lead, cadmium, and mercury. This is vital for electronics and automotive sectors. Biyuan’s production processes eliminate restricted materials through closed-loop solvent recovery and eco-friendly curing methods.


4. Production Quality Assurance

ISO 14001: Environmental Management

ISO 14001 certification reflects a commitment to reducing environmental impact. Biyuan’s facilities implement energy-efficient curing technologies and waste-reduction protocols, aligning with global sustainability goals.

OHSAS 18001 (Occupational Health & Safety)​

This certification prioritizes workplace safety in manufacturing. Biyuan’s operations include automated handling systems and employee training programs to minimize exposure to volatile organic compounds (VOCs).


5. Regional and Market-Specific Requirements

  • China GB Standards: For domestic markets, GB/T 36691-2018 specifies methods for vinyl content determination in silicone polymers.
  • 3A Sanitary Standards: Critical for food and beverage industries, ensuring smooth surface finishes (Ra ≤0.8μm) to prevent bacterial growth.
  • NORSOK M-701: Offshore oil and gas applications require certifications for chemical resistance under extreme pressure and temperature cycles.

Why Partner with Biyuan?​

Biyuan stands out as a leader in Vinyl Terminated Silicone Fluid production, combining technical expertise with global compliance. Their certifications—spanning FDA, ISO 13485, and REACH—ensure products meet the most demanding requirements. By integrating cutting-edge technologies like platinum-catalyzed vulcanization, Biyuan delivers fluids with exceptional stability and low environmental footprint.

For industries prioritizing reliability, Biyuan offers tailored solutions that align with international standards while maintaining cost efficiency. Whether for medical tubing, automotive seals, or industrial lubricants, their certifications validate performance and safety across applications.

Biyuan: Your Trusted Partner in Silicone Fluid Innovation

Delivering compliance, precision, and sustainability for global markets.


Keywords: Vinyl Terminated Silicone Fluid certifications, FDA-approved silicone fluids, ISO 13485 silicone suppliers, REACH-compliant materials, industrial silicone fluid standards.

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