Common Medical/Food & Beverage Tubing Specifications

Common Medical/Food & Beverage Tubing Specifications

NSF/ANSI 51
NSF International / American National Standards Institute standard for materials and components used in food equipment applications. Section 4 of the std. covers determining the suitability of materials used in a food zone based on formulation alone. The remainder applies to finished products.

NSF 51 Listed products include FB70-PVC, FB75-PVC, and Everprene-60.
Tubing made with NSF 51 materials includw FB60-TPV.
B. NSF/ANSI 61
NSF International / American National Standards Institute standard for materials or products that come into contact with drinking water, drinking water treatment chemicals, or both. The focus of the Standard is evaluation of contaminants or impurities imparted indirectly to drinking water.

Tubing made with NSF 61 materials include FB85-PVC and FB60-TPV.
C. USP Class IV


Class VI requires the most stringent testing of the six classes. Extracts of the test material are prepared in saline, alcohol in saline, polyethylene glycol (PEG 400), and vegetable oil. The extracts and blanks are injected into mice and rabbits, which are observed several times over a 72-hour period. The animals’ response to the sample extracts and the blank are compared to determine test passage. These tests of extracts are called the Systemic Injection Test and the Intracutaneous Test. Materials that pass these two tests are compliant with USP Class V.

USP Class VI includes the tests of USP Class V plus an implantation test wherein strips of the test material and a negative control are implanted in rabbits for a period of not less than 120 hours. Hemorrhage, necrosis, discolorations, and infections are macroscopically observed and degree of encapsulation is scored and compared with the negative control to determine test passage.
United States Pharmacopeia (USP) monograph 88 describes the classification of plastics into six classes based on responses to a series of in vivo animal biological reactivity tests.

You can find these products using the product finder.
D. FDA Title, 21 Chapter 1
U.S. Food and Drug Administration (FDA) regulations. Parts 170 – 199 apply to food additives including indirect additives as a result of contact with processing equipment and packaging.

Grayline carries a wide variety of tubing made from FDA 21 materials. You can find these products using the product finder.
E. 3A 18 Sanitary Standard
3A Sanitary Standard covering material requirements of rubber and rubber-like materials intended for multiple-use as product contact surfaces or solution contact surfaces in the production, processing and handling of milk or milk products. This standard covers materials only. It does not cover design and fabrication of components.
F. 3A 20 Sanitary Standard
3A Sanitary Standard covering material requirements of plastics for multiple-use as product contact and/or cleaning solution contact surfaces in equipment for production, processing, and handling of milk and milk product(s). This standard covers materials only. It does not cover design and fabrication of components.