Code of Federal Regulations Title 21. Food and Drugs § 21.26.60 Definitions

(a) The following terms and definitions shall apply to this subpart only:

(b) Other terms concerning conformity assessment used in this part shall have the meaning given elsewhere in this part or in the definitions contained in “Guide 2:  Standardization and Related Activities—General Vocabulary of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC)” (ISO/IEC Guide 2) (1996 edition), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the International Organization for Standardization, 1, rue de Varembé, Case postale 56, CH–1211 Genève 20, Switzerland, or on the Internet at http://www.iso.ch or may be examined at the Food and Drug Administration's Medical Library, 5600 Fishers Lane, rm. 11B–40, Rockville, MD 20857, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_lo cations.html. In the event of an inconsistency between the ISO/IEC Guide 2 and definitions in this part, the definitions in this part shall prevail.