UDI (barcode, datamatrix) Verification Solutions

Ronen E

Problem Solver
Staff member
Moderator
#21
Mil-std-130N says:
5.2.7.2.2 Calibration. Calibration processes and materials for reflectance criteria provided
by the verifier manufacturer are acceptable for printed labels when referenced to the nationally
traceable standard (GS1 US Calibrated Conformance Standard Test Cards)
Reading this, it seems that GS1 US Calibrated Conformance Standard Test Cards are the nationally traceable standard. :)
 
Elsmar Forum Sponsor
M

miken99

#22
Perhaps a bit of history might help.

Barcode verification standards were codified in 1990 through ANSI.

A bit later Applied Image, greif's company, made some of the first barcode calibration standard cards. They were purchased by a variety of companies directly from Applied Image by barcode developers and verification companies and delivered to consumer product manufacturers primarily.

Eventually GS1 started to purchase and resell the cards that AI made and then they private labeled AI cards. Now they make the cards for 2D and linear codes using new 'super verifiers' developed for the purpose.

Today, calibration cards are made by both parties and maybe others. There are a wide variety of cards that are made to suit various purposes. All create and test their cards characteristics using NIST traceable standards. To the best of my knowledge there is no national standard to be used exclusively. I think that the parenthsis was meant to mean 'like GS1' rather than specifying only GS1.

I certainly believe in standards and gage R&R. However, if you are really working on barcode printing systems where you are hoping that this level of precision is going to help bring your grade up above the minimum allowable, then I suggest you step back a bit and look at the big picture. You may need to increase the barcode size to bring up decodeability, increase contrast by using better inks or printing a background, etc. You may even have to step up your game and change to a printing system that is more capable. Todays target is ISO Grade 3-4 which gives you a bit of room for the inevitable goof up.

In many applications that barcode is no longer just another mark. It is data, money, automation, safety, relationships, etc.
 
Thread starter Similar threads Forum Replies Date
C UDI Label Verification - How do we ensure the barcode is correct and prove it? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I UDI requirements vs Japanese Barcode Marking guideline Japan Medical Device Regulations 1
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 0
J UDI - Where to document it? EU Medical Device Regulations 8
N UDI: GS1 or HIBC ??? EU Medical Device Regulations 1
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
C UDI Questions on Control Units Other US Medical Device Regulations 6
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
M UDI transition period and implementation EU Medical Device Regulations 6
M UDI size on packaging EU Medical Device Regulations 3
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
M UDI placement - Packaging levels EU Medical Device Regulations 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
M UDI-PI on a package that contains more devices EU Medical Device Regulations 3
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 7
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
P UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications? EU Medical Device Regulations 8
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
K Hospital UDI requirements Other Medical Device and Orthopedic Related Topics 7
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
J UDI Requirements - Products that all fall under the same family 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
M Informational EU – EUDAMED UDI Device Data Dictionary + data sets Medical Device and FDA Regulations and Standards News 0
M EU MDR - UDI requirements and responsibility guidance EU Medical Device Regulations 1

Similar threads

Top Bottom