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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 13-98
Standard
ISO IEC  646 Third edition 1991-12-15 (R2018)
Information technology - ISO 7-bit coded character set for information interchange
Identical Adoption
INCITS ISO IEC 646:1991 (R2018)
Information technology - ISO 7-bit coded character set for information interchange
Scope/Abstract
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 and other requirements.

This International Standard specifies a 7-bit coded character set with a number of options. It also provides guidance on how to exercise the options to define specific national versions and application-oriented versions. Furthermore it specifies the International Reference Version (IRV) in which such options have been exercised.

This character set is primarily intended for the interchange of information among data processing systems and associated equipment, and within data communication systems. The need for graphic characters and control functions in data processing has also been taken into account in determining this character set.

This character set is applicable to alphabets of the Latin script.

This character set allows the use of control characters for code extension where its character set is insufficient for particular applications. Procedures for the use of these control characters are specified in ISO 2022.

The definitions of the control characters mentioned in this International Standard are specified in ISO 6429. It is assumed that data associated with them are to be processed serially in a forward direction. When they are included in strings of data which are processed other than serially in a forward direction or when they are included in data formatted for fixed-record processing they may have undesirable effects or may require additional special treatment to ensure that they result in their desired function.
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 830 -- Unique Device Identification
21 CFR 801 Subpart B -- Labeling Requirements for 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, Issued 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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