Chapter 6 | Overview of Tests, Specifications, Practices, and Guides for Medical and Consumer Rubber Products

Abstract

ASTM Subcommittee D11.40 on Consumer Rubber Products oversees a large number of consumer and medical product standards, including specifications and test methods. Some of these standards are highly specific to a particular product, whereas others are more broadly applicable. Thus, certain test methods and materials standards will be cited in multiple product specification standards. Some standards specified by Subcommittee D11.40 target intrinsic composition of the materials from which the products are made or the intrinsic properties of the final product. In many product specification standards, test methods are cited that require following a method in a different standard, which may or may not fall under Subcommittee D11.40. All standards must be critically reviewed every five years and updated, amended, or corrected as needed. Standards no longer in use can be withdrawn by a vote from the subcommittee members, and working groups can be assembled to develop new standards desired by manufacturers. New standards often are intended to address limitations of existing standards, which only become obvious once a standard has been in active use for a period of time. Some limitations may be addressed by modifying the standard, which may entail an editorial change or a new revision before the five-year review, whereas others may require development and approval of an additional, separate standard. New standards also are demanded to address new materials, new products, new U.S. Food and Drug Administration regulations, and the potential for new product claims. Product features currently not defined or covered, but that are under discussion for future test method development, include durability in-use, fit, tactility, fixed point anchoring, and others.