Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
048
|
Date of Entry 12/04/2017
|
FR Recognition Number
|
13-99
|
Standard | |
IEC ISO 15459-2 Third edition 2015-03-01 Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
|
Scope/AbstractThis part of ISO/IEC 15459 specifies the procedural requirements to maintain identities and outlines the obligations of the Registration Authority.
This part of ISO/IEC 15459 excludes those entities where ISO has designated Maintenance Agencies or Registration Authorities to provide identity and/or identifier schemes. It does not apply to: - freight containers, because their unique coding is specified in ISO 6346, Freight containers - Coding, identification and marking; - vehicles, because their unique identification is specified in ISO 3779, Road vehicles - Vehicle identification number (VIN) - Content and structure; - car radios, because their unique identification is specified in ISO 10486, Passenger cars - Car radio identification number (CRIN).
The exclusion also applies to: - ISO 2108, Information and documentation - International standard book number (ISBN) and ISO 3297, Information and documentation - International standard serial number (ISSN);
NOTE The scope of each of ISO 2108 and ISO 3297 identifies the title rather than the individual copy of a book or periodical. As such, the level of identification achieved is at a level similar to the unique identity as defined in ISO/IEC 15459-6. Individual copies of a title (book or periodical) may be identified using ISO/IEC 15459-4.
|
|
Extent of Recognition
|
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)*
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Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff: July 25, 2016.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
|
Standards Development Organizations
|
FDA Specialty Task Group (STG)
|
|
*These are provided as examples and others may be applicable. |