Standards/hibc
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