UDI (barcode, datamatrix) Verification Solutions

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howste

Thaumaturge
Super Moderator
#12
:topic:

I realize that this thread is in the medical device regulations forum, but I thought I'd point out that barcode and Data Matrix requirements exist for defense/military hardware as well. You never know who will come across this thread in a search.

The verification requirements for defense/military are specified in MIL-STD-130N (with change 1) clause 5.2.7. "Marking quality conformance shall include validation and verification of mark content and quality." Acceptance criteria for linear bar codes are based on ISO/IEC 15416 . Acceptance criteria for data matrix can use ISO/IEC 15415, AIM DPM-1-2006, ISO/IEC TR 29158, or SAE AS9132. Calibration must be traceable to GS1 US Calibrated Conformance Standard Test Cards.
 
M

miken99

#13
In GS1 general spec
5.5.2.7.6 Symbol specification table 6 - Regulated healthcare non-retail consumer trade items not scanned in general distribution
Figure 5.5.2.7.6-1. GS1 system symbol specification table 6 Symbol(s) specified X-dimension mm (inches) Minimum symbol height for given X mm (inches) Quiet Zone Minimum quality specification
Minimum Target Maximum For minimum X-dimension For target X-dimension For maximum X-dimension Left Right
GS1- 128 0.170 (0.0067") 0.495 (0.0195") 0.495 (0.0195") 12.70 (0.500") 12.70 (0.500") 12.70 (0.500") 10X 10X 1.5/06/660
GS1 DataMatrix (ECC 200) (*) 0.254 (0.0100") 0.380 (0.0150") 0.495 (0.0195") Height is determined by X-dimension and data that is encoded 1X on all four sides 1.5/08/660
Sorry about the formatting but you willl get the idea - 1.5 for the average of 10 scans.

In HIBCC
5.0 Print Quality
5.1 Code 128 or Code 39
The bar code symbol quality for a Code 128 or Code 39 symbol in its final configuration shall be no lower than a
C/06/660 when measured according to ISO/IEC 15416 Information technology -- Automatic identification and data
capture techniques -- Bar code print quality test specification -- Linear symbols. Labelers should attempt to reach
B/06/660 or better at the time of printing.
5.2 Aztec Code, Data Matrix or QR Code
The bar code symbol quality for an Aztec Code, Data Matrix or QR Code symbol in its final configuration shall be no
lower
than a C/06/660 when measured according to ISO/IEC 15415 Information technology -- Automatic
identification and data capture techniques -- Bar code print quality test specification -- Two-dimensional symbols.
Labelers should attempt to reach B/06/660 or better at the time of printing.

In the spirit of the UDI rule, most understand that these barcodes must be able to be read, easily and accurately as the products move through the global supply chain. That will mean using laser scanners, imagers, from manufacturers in all parts of the world. Verification is both logical and required.
 

greif

Involved In Discussions
#14
A quick bit of info: I am told that GS1 will no longer be selling Calibrated standard test barcode cards. 1D and 2D cards are available at
AppliedImage.com (the 2D is just been released this week).
2D card PN is AI-CCS-DM-E

Looks like it is up on the website here:
Applied Image Barcode Calibration Standards

Scanner: reads the data encoded in a bar code
Verifier: reads the symbol and grades the quality on several parameters
The calibrated standard test cards are calibrated on a master verifier (10x or better than the typical industrial verifier) and supplied with documentation for photometric and linear distance traceability.


Full disclosure: I work at Applied Image and helped build the 2D calibration equipment (it was fun!)

*****************************************************
Moderator note: Caution - This post is under moderator discussion. There is no evidence that GS1 will no longer be selling Calibrated standard test barcode cards.
 
Last edited by a moderator:

howste

Thaumaturge
Super Moderator
#15
A quick bit of info: I am told that GS1 will no longer be selling Calibrated standard test barcode cards.
Do you have a source for this info that you can link to? Does this imply that there will no longer be a nationally traceable standard? :mg:
 

greif

Involved In Discussions
#16
I have only heard rumors that GS1 is getting out of the calibration card business, but their website store only has 2 types of cards listed (a 2D and a RSS)- which looks like getting rid of existing stock. They have been out of stock on 1D UPC cards for a year or more.
******************************
Moderator note: Caution - There is no evidence that GS1 will no longer be selling Calibrated standard test barcode cards.
 
Last edited by a moderator:
M

miken99

#17
I know that GS1 has built a 'super verifier' for linear barcode calibration cards. It was delivered fairly recently so it may just be an issue of starting up the system.
We did not build the system but we were involved and very familiar with the project.
 

greif

Involved In Discussions
#18
I knew they were working on a new 1D master verifier (I think the original delivery was supposed to be a year or two ago).

This is one of the reasons I wonder if they will pull out of the market for calibrated cards. Likely they will pull out, since they need a source of these 1D cards where all the symbols grade exactly in the center 1/3 of the grade range, and they are extremely difficult to make. (and it is a pretty small market for an outfit their size).
 

greif

Involved In Discussions
#19
Question; does Mil-std-130N restrict the testing of barcode verifiers only to GS1 test cards, or can any card that is referenced to nationally traceable standards be used?


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)

Maybe this is a little ambiguous, but wouldn't any Primary reference test symbol that was calibrated to "the nationally traceable standard" be suitable? Do the parentheses in the Mil Std. have special significance?
 

howste

Thaumaturge
Super Moderator
#20
Question; does Mil-std-130N restrict the testing of barcode verifiers only to GS1 test cards, or can any card that is referenced to nationally traceable standards be used?

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)

Maybe this is a little ambiguous, but wouldn't any Primary reference test symbol that was calibrated to "the nationally traceable standard" be suitable? Do the parentheses in the Mil Std. have special significance?
I don't claim to be an expert on this, but when I read MIL-STD-130N it seemed to imply that the GS1 cards are the ones they require. I'd welcome discussion on any other opinions.
 
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