How ASTM/ISO/FDA Works In Developing Standards (An Overview)

How ASTM/ISO/FDA works in developing standards

(An overview)

By: John S. Dick, Alpha Technologies

This paper gives an overview on how ASTM International, ISO and the United States FDA establish standards.

Health care standards are established by ASTM International, ISO, FDA and other organizations.  ASTM alone has at least 20 rubber standards relating to health care.  ISO has such standards as ISO 10993 on Biocompatibility which is very important.  And of course the FDA plays an extremely important role in the development of Health Care Standards.