Meeting stakeholders’ needs by blending HRI and regulatory requirements The GS1 system requires printing both the GS1 barcode and the HRI that represents all the information encoded within that GS1 barcode
Challenge
What is HRI?
• Shows a human exactly what’s in a barcode • Is used in addition to the barcode, particularly if the barcode does not read
Solution
Healthcare is complex Many countries have different requirements
Benefits
As a general rule, the law always supersedes the standards. Where it’s not possible to apply both HRI and non-HRI text it’s possible to combine them using the following methods:
Regulators are requiring more data in barcodes E.g. Batch information and serial numbers Lack of space The need for both regulated text and HRI
Technical challenges Barcodes are not part of the pre-printed artwork but instead have to be printed during production of the product
PC(01) EXP Lot(10) SN(21)
09504000059118 20 Nov 2014 7654321D 10987654d32
Method 1
Regulatory required text
If the data represented in the non-HRI text is exactly as in the HRI, then the appropriate application identifier (AI) shall be printed along with the data title
PC 09504000059118 EXP 20 Nov 2014 Lot 7654321D SN 10987654d32
Provides a consistent approach for the industry to follow when HRI and non-HRI text need to be combined to make efficient use of space. This prevents the introduction of multiple national requirements.
Regulatory required text PC 9504000059118 EXP 20 Nov 2014 Lot 7654321D SN 10987654d32
Method 2
PC (01) 09504000059118
If data represented in the non-HRI text does not match the HRI, then only a data title may be used. The AI shall not be printed
Lot (10) 7654321D
EXP
09504000059118 20 Nov 2014 7654321D 10987654d32
PC 9504000059118 EXP
http://www.gs1.org/demo/09504000059101
SN (21) 10987654d32 NN (713) 1312345678913
PC(01)
PC(01) EXP Lot(10) SN(21)
Scan for online product information or go to:
20 Nov 2014
09504000059118 EXP Lot(10) SN(21) NN(713)
20 Nov 2014 7654321D 10987654d32 1312345678913
Scan for online product informa;on or go to: h?p://www.gs1.org/demo/ 09504000059118
20 Nov 2014
Scan for online product information or go to:
Lot (10) 7654321D
http://www.gs1.org/demo/ 09504000059118
SN (21) 10987654d32
The selection of data titles may be determined by the manufacturer based on regulatory, local language requirements, relevant standards (e.g. ISO/IEC 15223) or appropriate abbreviations
Learn more at www.gs1.org/healthcare
The illustrations in this poster are examples of how Human Readable Interpretation (HRI) and other regulatory required text on a pack (non-HRI text) can be combined to make efficient use of space. Refer to GS1 General Specifications section 4.14.1 Healthcare human readable interpretation rules for details: http://www.gs1.org/docs/barcodes/GS1_General_Specifications.pdf
Meeting stakeholders' needs by blending HRI and regulatory ...
Meeting stakeholders' needs by blending HRI and regulatory requirements - GS1 Global Office.pdf. Meeting stakeholders' needs by blending HRI and regulatory ...
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