HIBC

Overview

HIBC (Health Industry Bar Code) is the supplier-labelling data standard administered by the Health Industry Business Communications Council (HIBCC), an ANSI-accredited standards body whose mission is to facilitate electronic communications among health-care trading partners [1]. HIBC defines how a labeler encodes product identity and production data onto medical-device and health-care-product labels [1] [2].

As with most AIDC standards, HIBC separates the data structure from the carrier symbology. The HIBC data structures (Primary and Secondary) can be carried in several symbologies — historically code-39, and now code-128, data-matrix, QR Code, Aztec and PDF417 [2]. HIBC is one of the three barcode systems recognized by the U.S. FDA for Unique Device Identification (UDI) [2].

History

HIBCC was formed to administer the HIBC standard and to issue Labeler Identification Codes (LICs), the per-manufacturer prefix embedded in every barcode that manufacturer produces [1]. The standard was originally defined for code-39; the current supplier-labelling specification is ANSI/HIBC 2.6 The Health Industry Supplier Labeling Standard (SLS) for Patient Safety and Unique Device Identification (UDI), with the syntax defined in ANSI/HIBC 5.0 and a separate provider-applications standard (ANSI/HIBC 1.x) [1] [3]. When the U.S. FDA released its UDI rule in 2013, HIBCC was accredited as one of the FDA's issuing agencies (alongside GS1 and ICCBBA — see isbt-128); HIBC formats are also recognized under the EU MDR [2].

Technical specification

Industry flag. Every HIBC barcode begins with a + character as the industry identifier, marking entry into the HIBC system [2].

Primary Data Structure. Identifies the product. It comprises [2]:

Field	Format	Length
Industry flag	+	1
Labeler Identification Code (LIC)	alphanumeric, assigned by HIBCC	4 (letter + 3 alphanumeric)
Product/Catalog Number (PCN)	alphanumeric	1–18
Unit of Measure (U/M)	numeric	1
MOD 43 check character	alphanumeric	1

Secondary Data Structure. Optional production data useful to distributors and providers — added at the labeler's discretion — encoding lot number, serial number, expiration date, manufacturing date and quantity, with its own MOD 43 check character. Expiration dates support multiple formats (MMYY, MMDDYY, YYMMDD, YYMMDDHH, YYJJJ, YYJJJHH); lot and serial numbers are up to 18 alphanumeric characters each [2].

Concatenation. Primary and secondary data may be encoded in separate symbols or combined into a single symbol using the HIBC LIC Concatenation Format, in which a slash (/) delimits the primary and secondary portions. In the concatenated case the secondary flag and its separate check character are omitted, and a single MOD 43 check character covers the entire concatenated string [2].

Check character. Each HIBC data structure uses a Modulo 43 check character — the mod-43 sum of all character values in the message, printed as the last character before the stop character — computed over all encoded data including the + flag, LIC, PCN, U/M and all secondary fields [2] [4]. When carried in code-39, regular (not Full ASCII) Code 39 is used and the mod-43 check is applied directly [4].

Carriers. Supported symbologies include code-39, code-128, data-matrix, QR Code, Aztec and PDF417 [2].

Use cases

HIBC is used for medical-device and health-care product supplier labelling, including device-level UDI marking (DI from the LIC + PCN; production identifiers from the secondary structure), hospital materials management, and distributor/provider supply-chain identification [1] [2]. It is particularly common among device manufacturers that label small, irregular or implantable items where the compact HIBC data structure and data-matrix carrier are advantageous.

Implementations

Open-source parsers and generators exist: wienand/hibc (Python parse + generate), chriswjones/HibcBarcodeParsing (Objective-C), and brixion/bardecoder (GS1/HIBC decoder). HIBCC also offers a hosted UDI-Builder tool and the HIN (Health Industry Number) System with API access [1].

Comparison

HIBC and GS1 are the two dominant medical-device UDI systems. GS1 builds its DI on the GTIN and carries production data via Application Identifiers in GS1-128 / gs1-datamatrix using FNC1 separators; HIBC builds its DI on the HIBCC-issued LIC + Product/Catalog Number, uses a + flag and / concatenation delimiter rather than AIs, and protects integrity with a MOD 43 check character [2]. Both are FDA-accredited UDI issuing systems; the third, ICCBBA's isbt-128, covers human-origin products [2]. HIBC's freeform alphanumeric PCN (up to 18 chars) lets manufacturers reuse their existing catalog numbers directly, whereas GS1 requires assignment of structured GTINs [2].

Status

Active. ANSI/HIBC 2.6 is the current supplier-labelling standard; HIBC is an FDA-recognized UDI format under 21 CFR Part 801 and is accepted under the EU MDR, making it a live, mandated option for device manufacturers worldwide [1] [2].

Sources

1 The Health Industry Bar Code Standards — HIBCC 2 HIBC / HIBCC Unique Device Identification (UDI) — BarcodeFAQ.com 3 ANSI/HIBC 2.6-2016 Supplier Labeling Standard — HIBCC, 2016 4 HIBC — Barcode Guide — Seagull Scientific

Deployments

No country reports mention this standard by name.

Regions / aggregations not mapped to a single country

• Universal