What are the Barcode Verification Requirements for My Industry?
Here are 9 frequently asked questions about barcode verification.
1. How does an industry know they have to verify barcodes?
将有一个行业委员会任务或政府任务。该行业将被要求遵守应用标准，该标准是每个行业的条形码指南。
2.什么类型的验证requirements does the U.S. Department of Defense have?
UID or IUID is the policy mandated by the U.S. Department of Defense (DOD) that provides the framework to acquire, track, maintain, and deploy assets. It dictates what needs to be marked and registered.
- IUID代表“项目唯一标识”，要求项目在IUID注册表中注册，并以板或标签的形式永久固定在资产上。
- UID代表“唯一标识”，它指的是用DPM条形码物理标记的资产时。
- MIL-STD-130 specifies text sizes, fonts, formats, location of the marks, size of marks, marking methods, and quality requirements.
国防部的条形码必须永久能够承受环境测试和清洁程序，并通过验证具有“ B”或更高质量的级别。验证者建立条形码等级，并允许用户跟踪这些单独的成绩。
3.我听说过军方使用AS9132标准，但是这是什么用途？
AS9132is a standard that defines barcode marking for the aerospace industry. It was developed by the Society of Automotive Engineers in 2002. It specifies six print quality and technical parameters for Data Matrix symbols that are direct part marked, specifically dot peen marked. The parameters include a quiet zone, symbol contrast, cell size, dot center offset, dot ovality, and angle of distortion.
值得注意的是，虽然AS9132是一种质量检查点peen代码的方法，该代码检查点的形状，但并未整体检查符号。例如，该标准不包括照明角度规范，因此结果可能因设置而异，并且不会检查Finder模式损坏或调制。因此，AS9132是监视或校准标记设置和针头质量的更好工具，而不是代码的可读性。
4.医疗设备制造商需要做什么来满足FDA要求？
The FDA mandates that all medical devices contain a UDI barcode. Unique Device Identifier (UDI) is a system that uses barcodes to identify medical devices throughout distribution and use. The goal of UDIs is to provide a safe and secure global distribution chain.
设备必须标记为条形码，该条形码列出了产品的批号，序列号和到期日期（如果适用）。此外，FDA还要求将每个UDI条形码中的一部分信息提交到其全局唯一的设备标识符数据库（GUDID）系统中。所需的信息取决于医疗设备类型。
UDI requirements have resulted in an increased demand for verifiers, especially DPM verifiers. All medical device barcodes need to have a “C” or higher quality grade to meet requirements. The only way to prove the barcode quality grade is with a verifier that indicates how well a barcode can be read.
5.公司何时满足UDI授权？
The deadline has been extended toSeptember 24, 2022。
6. What about the pharmaceutical industry? What are their requirements?
In 2004, the FDA issued a new rule requiring certain drugs and biological products labels to have 1D barcodes containing a national drug code (NDC).
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 withISO 15415。
7。What is 21 CFR Part 11 and which industries use it?
In 1997, the FDA issued regulations that established the criteria for acceptance of electronic records and signatures. The rules apply to companies in pharma, medical devices, biotech, biologics developers, and other FDA regulated industries.
These regulations require companies to have a system in place to lock down settings, track user changes, and securely store documents.
8. How do validation protocols fit into all of this?
为调药的设计验证协议al and medical device manufacturers that are bound by FDA regulations. They help ensure the highest quality standards are being met.
Validation protocols check every possible setting combination that a verifier can perform during the testing process. They include hundreds of test barcodes, each designed to test specific operational characteristics of the verifier. Each combination is tested with verification, which documents that the results are as expected.
9. Even if my industry is not required to verify, should I?
Yes, absolutely. There are several reasons to choose verification over barcode quality software, including:
- Validating to an industrywide standard solves potential readability debates between vendors.
- Reports produced by verifiers can be used to prove code quality at the time of marking and that incoming codes are not acceptable.
- Verification guarantees that all barcodes can be decoded by DPM readers and is the best way to confirm proper calibration of laser or dot peen marking machines.
- Verification helps pinpoint when line or machine components fail and ensures that all equipment is performing at the highest efficiency.
- Verifiers feature real-time tracking of when the print or marking quality drops below the user setup threshold.
如果您决定验证，请确保使用符合ISO的设备。由于对验证者的硬件和软件设置进行了调节，因此结果更值得信赖。如果您仅使用条形码质量软件，则照明设置可以因线而异，并且没有校准过程。此外，该软件用于建立等级的算法是未知的，因为它们不遵守ISO标准。
10.在哪里可以找到符合ISO的条形码验证器？
Cognex提供了一系列符合ISO的条形码验证器，它们使用高质量的光学元件，高级算法和简单的软件来证明符合行业标准准则。看看我们family of barcode verifiers here。
In conclusion, if your industry has specific barcode verification requirements, it’s important to be up to date on those regulations by checking your verifiers’ capabilities and ensuring you submit the appropriate information to each agency by the given deadline. Even if your industry is not bound by verification requirements, you may want to consider verification to ensure your barcodes can be decoded properly.
