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Silicone Tube Application Standards: RoHS, FDA, LFGB & Biocompatibility

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Silicone Tube Application Standards: RoHS, FDA, LFGB & Biocompatibility

Silicone Tube Application Standards: RoHS, FDA, LFGB & Biocompatibility

As people’s living standards continue to improve, more attention is being paid to the safety standards of products and their components.

Silicone tubes are among the most widely used supporting parts, and have become indispensable in industry, food, medical treatment, biopharmaceuticals, and many other fields.

They appear in daily life as baby bottle straws, in food and medical equipment as connecting tubes,

and in industrial machinery as conveying tubes or protective sleeves.

But how many people really understand their applicable safety standards?

Below, Shenzhen Taihua Silicone Products Co., Ltd. explains the common application standards for daily-use silicone tubes.

Environmental protection and safety standards for silicone tubes are mainly divided into four grades:

RoHS, FDA, LFGB, and Biocompatibility Report.

Each test covers different items, so their safety levels and applicable scenarios also vary.

1. RoHS Testing (Industrial Grade Silicone Tubes)

RoHS initially restricts 6 hazardous substances:

lead (Pb), cadmium (Cd), mercury (Hg), hexavalent chromium (Cr⁶⁺), PBBs and PBDEs.

The standard has now been expanded to 10 restricted substances,

adding DBP, BBP, DEHP and HBCDD.

Industrial-grade silicone tubes that meet RoHS standards

are widely used in machinery, electronics, toys, home appliances and other industrial fields.

2. FDA Testing (Food Grade Silicone Tubes)

FDA is the standard issued by the U.S. Food and Drug Administration,

tested according to 21 CFR 177.2600.

Food-grade silicone tubes with FDA certification

are mainly used for conveying and connecting food, beverages, drinking water and other edible products.

3. LFGB Testing (Food Grade Silicone Tubes)

LFGB is the German food and commodity safety standard.

It includes sensory tests, total migration, volatile organic compounds, peroxide residues and organotin tests.

In China, LFGB-certified silicone tubes are most commonly used for baby bottles,

since infants have relatively weak immunity.

LFGB is also one of the most popular certifications for products exported to Europe and the United States.

4. Biocompatibility Report (Medical Grade Silicone Tubes)

Medical-grade silicone tubes require a formal biocompatibility test, which mainly includes 5 items:
  • Cytotoxicity
  • Sensitization
  • Skin irritation
  • Systemic toxicity
  • Hemolysis (blood compatibility)
These tubes are widely used in medical machinery, instruments, devices, biopharmaceuticals and other high-standard medical fields.

Conclusion

Shenzhen Taihua Silicone Products Co., Ltd. can customize silicone tubes in various specifications and colors

according to the above standards to meet different certification requirements.

Customers are welcome to consult, send drawings or samples, or visit our factory for cooperation.

This article is original by Shenzhen Taihua Silicone Products Co., Ltd.

Please indicate the source when reprinting.

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