WI-F-001 Health Industry Bar Code (HIBC) Formatting

Revision A
Rev Description of Change Reason for Change Revision Author Effective Change
Date Number

A Initial Release To establish guidance Vanesa Fields 08/25/2015 CN-1016

for standard document
creation
To meet
documentation control
requirements per 21
CFR 820.60, 21 CFR
820.65, 21 CFR
820.120
 HIBC Bar Code Formatting WI-F-001 Rev A
Specification Effective Date:08/25/15

1. Purpose and Scope

1.1. This specification covers the requirements for the Health Industry Bar Code (HIBC)
formatting for the Packaging/Labeling of the Modal Manufacturing Components.

2. Responsibilities
2.1. It is the responsibility of Engineering, Quality, and the approved vendors to assure that
all parts are manufactured utilizing specified and certified procedures/processes.
2.2. It is the responsibility of the Quality Department to provide adequate controls to assure
compliance to this specification

3. References
3.1. ANSI/HIBC 2.4-2013 – Health Industry Bar Code (HIBC) Supplier Labeling Standard
4. Barcode Requirements:

The barcode requirements are to the health industry bar code standard (HIBC).

The barcode symbology is code 128 or code 39 with variable modulo 43 check sum
digit. Either the primary and secondary barcode or the concatenated barcode may be
utilized based upon available label area.

Where a labeler decides to use a linear symbology, the labeler may use either of the
linear symbologies in this section as directed.

• Code 128: HIBC primary and secondary data should be printed in separate Code 128
symbols but may be concatenated if space allows. More information on this symbology
may be obtained from ISO/IEC

15417 Information technology -- Automatic identification and data capture techniques --

Code 128 bar code symbology specification.

• Code 39: HIBC primary and secondary data should be printed in separate Code 39
symbols but may be concatenated if space allows. More information on this symbology
may be obtained from ISO/IEC

16388 Information technology -- Automatic identification and data capture techniques --

Code 39 bar code symbology specification.

If Code 39 is used, the Regular setting (not Full ASCII) should be used. In addition, the
full ASCII function shall be disabled in the reader. The wide to narrow ratio should be
3:1, the inter-character gap should be equal to the nominal narrow element dimension
(X-dimension) and the optional Mod 43 symbology Check Character is used.

5. Combining Primary and Secondary Codes in One Symbol when Using the HIBC LIC

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 HIBC Bar Code Formatting WI-F-001 Rev A
Specification Effective Date:08/25/15

Format

6. When combining the Primary and Secondary Code into a single symbol (known as
concatenation), a forward slash (/) is used as a delimiter between the primary and
secondary data. In addition, the primary data Link Character, and the plus (+) at the start of
the secondary data, and the secondary data Link Character are omitted. Only one Check
Character at the end of the symbol will be used which will check the entire data string.

7. For example:

+ A 9 9 9 1 2 3 4 5 / $ $ 5 200 0 1 5 1 0 X 3 6

Where:

+ HIBC Supplier Labeling flag

A999 LIC

1234 Product ID

5 Unit of Measure

/ Data delimiter (to separate the primary from secondary data)

$$5 Exp Date Flag

20015 Expiry Date is 15 day of year 2020 (15 January 2020) in the YYJJJ format
(Julian Date format)

10X3 Lot Number

6 6 is the Check Character

2.2.2 Secondary Data Structure in Electronic Data Interchange

For information about communicating Secondary Data in Electronic Data

Interchange, refer to the HIBCC Electronic Data Interchange (EDI) Guidelines.
When using the HIBC data formats in Electronic Data Interchange, the Check
Character is not transmitted or stored in the database.

8. Bar Code Examples

8.1. Refer to ANSI/HIBC 2.4-2013 for examples of formats and printed symbols for bar
codes.

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