In 2004, the FDA issued a new rule requiring certain drugs and biological product labels to have 1D barcodes containing a national drug code.
In 2015, the Drug Supply Chain Security Act required pharmaceutical products to be marked with a 2D code containing the NDC number, serial number, lot number, and expiration date. Those codes must have a ‘C’ or higher grade in accordance with ISO 15415.
The Unique Device Identification (UDI) initiative through 2022 requires every manufacturer that produces a reusable or reprocessed device (surgical instruments, operating room accessories, implants) to place a DPM code on the device.
Per the UDI mandate, devices must be labeled with a barcode that lists a product’s lot number, serial number, and expiration date if applicable. Additionally, the FDA also requests that a portion of the information within each UDI barcode be submitted to the FDA’s Global Unique Device Identifier Database (GUDID) system. The information required depends on the medical device type.
All barcodes need a ‘C’ or higher quality grade. The only way to prove the barcode quality grade is with a verifier that indicates that a barcode can be read.
The Automotive Industry Action Group (AIAG) founded the Barcoding Project Team in 1981 to develop automotive industry standards for barcodes. Since then, barcodes have been instrumental in the supply chain standards for the industry. In 1984, AIAG adopted the Code 39 alphanumeric symbology and published the first industry-wide barcode standards: Barcode Symbology (B-1) and Shipping/Parts Identification Label (B-3).
Since the initial founding of the Barcoding Project Team, other guidelines for suppliers to the automotive industry have been created, including industry-wide and company specific initiatives. A few of the industry standards are listed below:
- GM 1724: This is General Motors’ global label specification. Webscan has been certified for compliance with this labeling standard. The TruCheck Optima and TruCheck Omni verifies the PDF 417 symbols incorporated on these shipping labels.
- AIAG B-17: This is a 2D Direct Parts Marking Guideline for the automotive industry. Webscan was an instrumental contributor to the development of this document. The guideline uses AIM DPM standards for verifying the quality of the barcode. The TruCheck 2D USB DPM or TruCheck FlexHite verifier is ideal for this application.
The aerospace industry utilizes a variety of symbologies and marking methods. Label systems use both linear 1D and 2D symbologies including Data Matrix codes for unique baggage handling solutions like identification, inventory movement, and control. Mechanical parts made of plastic, aluminum, ceramic, and steel are in many cases directly marked with dot-peening, laser and chemical etching, and other marking methods.
Linear barcodes (Code 128, Code 39 in the ATA Spec 2000) on labels and nameplates can be graded according to ISO-15416 quality specifications with the TruCheck Optima or TruCheck Rover systems.
Data Matrix barcodes referenced in both the ATA-Spec-2000 and the United States Department of Defense’s Standard Practices for Uniquely Identifying Military Property (MIL-STD-130) can be verified utilizing all Webscan verifier systems, specifically the DPM models. Webscan 2D barcode verifiers have the capability to verify according to any of the quality specifications, including AS-9132, the aerospace industry’s own specification for direct part marks.