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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 048 Date of Entry 12/04/2017 
FR Recognition Number 13-101
Standard
ISO IEC  15459-6 Second edition 2014 Corrected 2016
Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
Scope/Abstract
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 the entity to meet management needs and/or regulatory needs (e.g. customs clearance). To address these needs different types of identifiers are recognized in the various parts of ISO/IEC 15459, which allows different requirements to be met by the unique identifiers associated within the context of the specific parts of ISO/IEC 15459.

The unique identifiers for grouping or products, product packages, transport units and items enables grouping by e.g. type, characteristics, order, manufacturing, quality, location, movement, etc. to be uniquely identified. It is possible to use with other unique individual identifiers defined in other parts of ISO/IEC 15459. Encoding these unique identifiers in a data carrier enables information about the item processing to be clearly identified.

The identity for groupings is intended for "look-up" purposes, and cannot be directly used as an entity identity in the strictest sense of the definition as used, for example, in ISO/IEC 15459-1, ISO/IEC 15459-4, and ISO/IEC 15459-5.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR 801 Subpart B -- Labeling Requirements for Unique Device Identification
21 CFR 830 -- Unique Device Identification
Relevant FDA Guidance and/or Supportive Publications*
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff: July 25, 2016.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Michael Simpson
  FDA/OC/CDRH/OPEQ/ORP/IO
  301-796-4070
  Michael.Simpson@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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