Label Making & Printing Standards ISO / ASTM


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We manufacture Orthopedic implants , would like to know if there are standards for making a label ie. what type of paper or adhesive that can be used etc. also if there is a standard for the printing ink that can be used for laser or other type of printers .as the ink should not fade or be wiped out but should be clearly visible for the shelf life of product.

Any comments , suggestions would be highly appreciated



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Hi Michelle,
Interesting question. To my knowledge, there is no standard for making a label and I suspect there won't be. Each manufacturer defines what he expects from the label and should verify that. It's not black and white (ha ha...) there are different label thickness, inks, lamination, resistance to different cleaning material, and different costs. I think it's best not to impose restrictions on labelling print purses.


monoj mon

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Just in case if it helps, we try to follow few points;

1. Not to get too glossy material for the label
2. Print with Dark color ink (preferably black) on lighter background (preferably white)
3. In terms of adhesiveness, if the labels are not designed to be removable then no one should be able to remove it without destroying its integrity.

Regarding quality, you may approach vendors who also specialize in supplying labeling components to Medical Device companies.


There aren't any standards defining types of paper or ink, but definitely check 60601-1, section 7.1.3 and Annex B for rub test. Another important thing to keep in mind if this is a device that will require sterilization after labeling, the label will need to be able to survive that process as well.



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ISO 20417-2021 Information to be supplied by the manufacturer calls out specifics with regards to legibility of labels (6.3) and durability of markings (6.4).


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In the US, some of the product safety standards refer to ANSI 969 as a labeling and marking system requirement. UL runs a program around that:
Marking and Labeling Systems Program

I am generally not a fan of UL-specific programs (certification lock-ins, etc.), but they do provide a quick route to compliance.

Worst case (and what I've done a few times) is demonstrate to the certification body that our labels meet the requirements for indelibility, chemical compatibility, adhesive strength, heat resistance, etc. This is mainly around laser engraved plastic stock that is flame rated only, but not otherwise tested to a label or marking standard, or laser etching on anodized parts, where the etching is in lieu of a label. Think similar to Macbook compliance labels on the underside case.
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