Iso Iec 15459-4

[Bonifacia Cramm]

ISOIEC 15459-4:2014 specifies a unique string of characters for the identification of individual products and product packages. The character string is intended to be represented in a linear bar code symbol or two-dimensional symbol or other automatic identification and data capture (AIDC) media attached to the entity to meet management needs. To address management needs, different classes of identities are recognized in the various parts of ISO/IEC 15459, which allows different requirements to be met by the identities associated with each class.

The rules for the identification of an individual occurrence of a product or product package, understood to mean the layers zero and one defined in ISO 17367 and ISO 17366, respectively, are defined and supported by examples.

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Unique identification can occur at many different levels in the supply chain, at the transport unit, at the item level, and elsewhere. Such distinct entities are often handled by several parties: the sender, the receiver, one or more carriers, customs authorities, etc. Each of these parties must be able to identify and trace the item so that reference can be made to associated information such as configuration, maintenance history, address, order number, contents of the item, weight, sender, batch or lot number, etc.

There are considerable benefits if the identity of the item is represented in bar code format, or other AIDC (Automatic Identification and Data Capture) media and attached to or made a constituent part of that which is being uniquely identified so that

The unique identifier for individual items defined in ISO/IEC 15459-4:2008 and represented in a bar code label, two-dimensional symbol, radio-frequency identification tag, or other AIDC media attached to the item meets these needs.

All AIDC technologies have the potential to encode a unique identifier. It is expected that application standards for items, using various automatic identification technologies, will be developed based upon the unique identifier as a prime key. These application standards may be made available from the Issuing Agency.

ISO/IEC 15459-4:2008 specifies a unique, non-significant string of characters for the unique identifier for individual items. The character string is intended to be represented in a bar code label or other AIDC media attached to the item to meet supply chain needs. To address management needs, different classes of items are recognized in the various parts of ISO/IEC 15459, which allows different requirements to be met by the unique identifiers associated with each class. The rules are defined for the individual items to identify the unique occurrence of an item, understood to mean the layers zero and one as will be defined in two future International Standards (ISO 17367 and ISO 17366, respectively).

The product code shall comply with Article 4(b)(i) and Article 5(5) of Commission Delegated Regulation (EU) 2016/161 (so called Delegated Acts). The product code is not allocated or approved by the Institute. The marketing authorisation holder has to safeguard the upload of the data elements of the unique identifier, the coding scheme of the product code, and other data to the repositories system, as referred to under Article 33(2) of Delegated Acts, prior to the release of the medicinal product by the manufacturer. Pursuant to the Delegated Acts, the product code has to be coded as a data element of a unique identifier in the data matrix in compliance with the coding scheme and at the beginning has to bear characters specific for the applied coding scheme. Furthermore, it has to contain characters or character sequences identifying the product as a medicinal product. The resulting code has to have less than 50 characters and has to be globally unique. Product codes which are compliant with the ISO/IEC 15459-3:2014 and ISO/IEC 15459-4:2014 standards are considered to be meeting the requirements set forth by these Delegated Acts. In the Czech Republic, 2D codes are allocated by GS1 Czech Republic. The product code may assume the GTIN, NTIN, EAN format or another code format.

Standards Australia has adopted the following ISO standards as Australian standards. In line with internationally recognised compliance and harmonisation, these standards also incorporate equivalent ISO (International Organization for Standardization) standards that have been scrutinised and ratified as meeting Australian requirements.

This suite of standards, has been developed in the area of Automatic Identification and Data Capture. The standards stipulate which identifier can be used for specific purposes and what attributes can be leveraged with the relevant identifiers.

As an example, you may want to identify an individual product or product package. The standard, AS ISO/IEC 15459-4, defines that you can use the GS1 identifier/key Global Trade Item Number to comply with the standard.

GS1 and ISO (International Organization for Standardization) share the same values and beliefs in the vital importance of neutral, voluntary, consensus based, market relevant global standards. ISO and GS1 have had a long standing working relationship and now Standards Australia and GS1 Australia are working together to support the national recognition of relevant standards for our country to support our local engagement in sectors where the reference of standards is critical.

Sectors such as Healthcare, Rail, Construction, Transport and Logistics have been consulted in the development of these standards. Topics related to the use of the GS1 system such as traceability, sustainability and the circular economy have been considered, where government is seeking to align locally and globally to achieve common approaches to key problems.

For this first release, we are focused on standards in the Automatic and Identification and Data Carrier space of standards. These identify the GS1 identifiers (keys) that apply in different use cases and stipulate the Application Identifiers present in our standards.

The GS1 standards themselves are not impacted; they continue to be managed within the GS1 standards process called the Global Standards Management Process (GSMP) and will continue to do so. The collaboration between ISO and GS1 recognizes the components of the standards to support emerging needs in highly regulated sectors, particularly in government.

This development gives confidence to GS1 members, and those who leverage GS1 standards day-to-day, to support the concept of adopting globally accepted, locally approved standards to support their business operations. It ensures alignment, protects existing investment and further leverages the use already implemented systems.

Yes, GS1 Australia is looking at other ISO standards that incorporate or reference GS1 standards and working with the Standards Australia process to have these referenced as Australian standards.

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