ASTM Standards for Medical Products and Materials

ASTM International medical device standards are full consensus standards developed by a cross –section of stakeholders with an interest in its use. Requests for new standards come from manufacturers, consumer groups, professional bodies, government agencies and trade associations or individuals. ASTM standards developments ensure fairness to the stakeholders through a required balance of interest between producers, users, and general interest members and a voting process that ensures due process.  

ASTM standards for medical gloves, condoms and related standards are developed by the Subcommittee D 11.40 on Consumer Rubber Products under Committee D 11 on Rubber. Many are recognized by the U.S. Food and Drugs Administration as  consensus standards for declaration of conformity for submission for 510(k) marketing approval to market the product in the U.S.  They are used by over 70 countries which signed Memorandum of Understanding with ASTM. This paper will briefly review the D 11.40 medical device standards.