Jun 13 2006
The American Society for Testing and Materials (ASTM), one of the largest standards development organizations in the world, has created a new latex category which specifies, for the first time, safety standards based on protein content.
The ASTM D1076-06 standard defines a new Category 4 natural rubber latex that includes Guayule or other natural rubber latex containing less than 200 micrograms total protein per gram dry weight of latex and no detectable protein by the ASTM D 6499 standard method for quantifying Hevea antigenic protein. At the present time Yulex natural rubber latex is the only natural rubber latex that meets the new Category 4 standard, and, therefore, provides a new level of materials safety for medical product manufacturers.
Yulex also meets the category’s high performance standards based on its natural elasticity, tensile strength, barrier protection, durability, and elongation characteristics.
“We are pleased that the ASTM Latex Committee recognized the need for a specific safety standard without lowering the performance standards to accommodate synthetic materials,” says Jeffrey Martin, CEO and president of Yulex Corporation. “Yulex Latex contains all the physical properties necessary for high-grade medical gloves without the proteins that cause latex allergy.”
Previous to this revision, the ASTM D1076-02 Standard Specification for Rubber contained three types of rubber-concentrated raw material latex – ammonia preserved, creamed, and centrifuged natural latex. All three measured physical performance only, not protein content, and applied to Hevea-based raw materials derived from tropical rubber tree plantations mainly in Southeast Asia.
ASTM International also coined a new term for Guayule natural rubber latex—natural rubber Guayule latex or NRGL--because it recognized that natural rubber latex (NRL) is not adequate for describing latex made from Guayule. This new category positions Yulex as a viable and leading alternative to traditional NRL sources for the medical device industry.
ASTM provides a management system for the development of standards and related information for materials, products, systems, and services used internationally as well as nationally. All segments of an industry (producers, users, consumers, government, and academia) participate in the development of this information to ensure that all technical points of view are represented - it is extremely important that all parties are confident they will have fair and equal representation in the development of the final consensus standards. Finally, ASTM provides leadership and management support for 138 standards developing committees. These committees have produced over 12,000 standards for an extremely diverse collection of industries.
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