Recognized standard

15459-6 Second edition 2014 Corrected 2016

FDA recognition 13-101 · ISO · Software/Informatics

Key facts

Recognition number 13-101
Designation 15459-6 Second edition 2014 Corrected 2016
Title Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
Standards developer International Organization for Standardization
Specialty area Software/Informatics
Date of entry Dec 4, 2017
Scope (excerpt) This part of ISO/IEC 15459 specifies a unique string of characters for the identification of groupings of products, product packages, transport units and items. The character string is intended to be represented in a linear bar code symbol and two-dimensional symbol or other AIDC media attached to…

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