Recognized standard

646 Third edition 1991-12-15 (R2018) 646:1991 (R2018)

FDA recognition 13-98 · ISO · Software/Informatics

Key facts

Recognition number 13-98
Designation 646 Third edition 1991-12-15 (R2018) 646:1991 (R2018)
Title Information technology - ISO 7-bit coded character set for information interchange
Standards developer International Organization for Standardization
Specialty area Software/Informatics
Date of entry Dec 4, 2017
Scope (excerpt) This International Standard specifies a set of 128 characters, (control characters and graphic characters such as letters, digits and symbols) with their coded representation. Most of these characters are mandatory and unchangeable, but provision is made for some flexibility to accommodate national…

At a glance

  • None Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards