Device Labeling Glossary | Network Partners

General

Country Specific Labeling: Label added to the product packaging that contains information specific to a shipping destination that is not present on the primary product labels. May contain additional languages, product data or statements.
eIFU: Electronic version of Instructions for Use typically made available on the company product website for viewing / download.
Implant Card: Card completed by the physician for the patient that documents the detailed information related to implant used and its location.
Instructions for Use (IFU): Instructions provided with the product for safe and efficacious use of a product. Commonly used forms are booklets, maps and sheets.
Label: Material affixed to the product packaging with information concerning the product.
Label Validation: Confirmation that arrangement and format of a label conveys intended information.
Label Verification: Confirmation that label stays affixed and legible through rigors of distribution and storage.
Labeling: Any information printed on or affixed to the product packaging the partially or completely describes the product.
Literature: Any printed materials that partially or completely describes or promotes the product. May take the form of brochures, posters, quick reference guides, promotional items, etc.
Material Identification Label: Label for in-house use to identify manufacturing materials or subassemblies.

Materials

Continuous label stock: Uncut label stock typically used with online label printers. Label printers require a cutter installed to cut the labels as they are printed.
Continuous web stock: Uncut Tyvek® or pouch material used in the online label printing process. Requires a cutter to be installed on the label printer to cut the material between prints.
Die-cut label stock: Adhesive-backed label that is cut to specific dimensions. May include peel-away segments.
Label stock: Material used to create labels. May contain specific finishes or varnishes depending upon the printing process used.
Piggyback label stock: Triple-layer label stock consisting of two backing paper layers and one label stock layer. Typically used when a peel-away segment is placed on the edge of the label stock.

Barcodes

2D Data Matrix: A two-dimensional data matrix code consists of black and white cells (also referred to as dots) that are typically configured into a square or rectangle pattern. This is referred to as a matrix. Information can be encoded into the matrix as either text or numerical data.
AIDC (Automatic Identification Data Capture): Refers to the methods of automatically identifying objects, collecting data about them, and entering them directly into computer systems, without human involvement. A very common form of AIDC is a barcode.
Alphanumeric: Describes a data string that can include letters, numbers and characters.
Application Identifier: GS1 numeric code included in the barcode string that indicates the specific information that follows it.
Auto discrimination: The ability of a barcode analyzer to detect the type of barcode symbology when scanned.
Barcode: A sequence of bars and spaces that translates data into a machine-readable format.
Barcode character: A group of bars and spaces that translate into a specific letter, number or character.
Barcode density: The number of characters present per characters per inch (CPI).
Barcode grader or verifier: A device that is used to verify the grade of a barcode based on ISO 15415, ISO 15416 and ISO 15417.
Barcode reader / scanner: Device that reads and translates a barcode into a human / machine-readable format.
Barcode symbology: Refers to the specific symbology used.
Check digit or Check sum: Character appearing at the end of a barcode string that confirms the code is correctly translated. Common check digits used are Mod 10 and Mod 43.
Code 128: Linear barcode symbology that can be used for either alphanumeric or numeric-only barcodes. Formerly known as UCC/EAN-128 and is used extensively worldwide for all packaging levels of the supply chain. Considered a high data density barcode.
Code 39 (3 of 9): Liner barcode symbology consisting of uppercase letters, numbers and a specific set of special characters. Utilizes start/stop characters “*”. Considered a low data density barcode.
Datamatrix or QR Codes: 2D barcode configuration.
EAN: European Article Numbering organization. Merged standards with UCC in 1990 to form GS1.
EAN-13: Symbology for specific retail product types.
EAN-8: Symbology derived from EAN-13 for use on small packages where EAN-13 would be too large. Applies to retail product types.
GS1: Organization that develops and maintains global barcode standards for business communication. Designed to improve the efficiency, safety and visibility of supply chains. Used for both retail and professional products.
GTIN: GS1 term used for Global Trade Item Number. Refers to the data string contained in a barcode that identifies the manufacturer, package level / configuration, product code and check digit.
HIBCC: Health Industry Bar Code Council.
Numeric: Describes a data string that is comprised only of numbers.
Primary barcode: Refers to a linear barcode that contains the product GTIN.
Secondary barcode: Refers to a linear barcode that contains the Use By Date (if applicable), Manufacturing Date, Lot or Serial Number and any other necessary data.
Start / Stop character: Characters used to denote the beginning and end of a barcode. “*” character is most commonly used.
UCC: Uniform Commercial Code organization. Merged standards with EAN in 1990 to form GS1.
UPC: Universal Product Numbering organization widely used for tracking retail products.

Printing Processes

Digital printing: Method of printing from a digital-based image directly to a variety of media. Digital printing is a higher cost per page than offset printing, but the price is usually offset by avoiding the cost of technical steps required to create printing plates and supports short turnaround times.
Flexographic printing: Printing process which utilizes a flexible relief plate. Considered a modern version of letterpress that is equipped with high speed rotary functionality which supports printing on almost any type of media including plastic, metallic films, cellophane and paper. Well-suited for printing large areas of solid color.
Offline printing: Refers to the practice of printing labels in a different location than the production line and issues labels for use.
Offset printing: Most commonly used printing technique in which the inked image is transferred from a plate to a rubber blanket, then to the printing surface. Employs a flat image carrier. Ink rollers transfer ink to the image areas of the carrier, while a water roller applies a water-based film to the non-image areas.
Online printing: Refers to the practice of printing labels on the production line.
Trigger printing: Refers to an online printing process that requires the scanning of a barcode(s) or other trigger to produce a single label correct label as opposed to utilizing a hand entry.

Systems

21 CFR 21 Part 11: Federal Regulation for software systems to have electronic signatures, includes audit logs and versioning.
Artwork system: System used for desktop publishing. Usually comprised of illustration, page layout, image manipulation and PDF editing software.
Commercial Off-the-Shelf software (COTS): Software that is ready to use without customization. Can have configurable aspects.
Custom software: Software that is developed for internal use and not commercially available.
Label applicator: Automated hardware used to apply labels to packaging components.
Labeling system: System used for in-house printing on the production line. Typically comprised of a computer with label software installed and a label or desktop printer.
Labeling vault: Software system used for the controlled storage of label files. Document control systems are most often used for this purpose.
Software validation: Process used to test and document that the software performs as intended per a specific set of rules and / or testing methodology.
Vision inspection: Automated system used to verify a printed label to a pre-approved template.

Other

Anti-counterfeiting: Measures taken to prevent the theft, destruction or replacement of the original product, use in illegal transactions or to otherwise deceive the recipient. A variety of methods used include, but are not limited to holographic labels and / or data added to barcodes.
Artwork: Files created for the purposes of vendor-supplied printed materials.
Label printer: Specialty printer exclusively designed for printing labels. May be thermal transfer or direct thermal which requires a specific varnish to be applied to the label stock for consistent, permanent and reliable print quality.
Label reconciliation: Process used to ensure all labels issued have been used, destroyed or removed from the production line, and designed to prevent label mix-ups between product lots.