Safety labels seem like a basic enough component of a product to not warrant serious consideration, but for medical device manufacturers, that type of thinking could lead to serious consequences. This article will provide a high-level overview of the label development process, including a look at a couple of the organizations setting the standards, the basic elements of label development, and the proper label appearance.
ANSI and ISO
Safety Label Design and Development
Pictures are the universal language when it comes to communications, no matter a person’s native tongue or literacy level. Wherever possible, manufacturers should try to use pictorials to accompany their messages so that end users have the opportunity to visualize the hazard and see how to avoid it without needing to read. This is particularly important due to the vast number of foreign languages currently in use, not to mention the many countries which employ multiple dialects. All of this pertains to the United States as well due to the influx of Spanish speaking people and the illiterate. Fortunately, these language barriers can be readily addressed with the use of pictorials.
While pictorials provide the important visual component of the hazard, the verbiage included on the safety label provides more finite detail around the hazard, hazard avoidance, and consequences. At this point in the label development process, a manufacturer has already provided the initial verbiage needed for the label
The remaining verbiage is a description of the consequences of not avoiding the hazard. In the example, the text would read, “Failure to comply could result in death or serious injury.” All of this verbiage would be coupled with pictorials illustrating the magnetic hazard and the avoidance action.
To develop effective verbiage for safety labels, wording must be succinct and use a headline-style format. Label designers must avoid using excessive, unnecessary words (e.g., the) while presenting the text in easy-to-read upper and lower case letters. Note that it is acceptable to use all upper case letters in short phrases requiring impact, like MAGNETIC HAZARD.
Next, be mindful of the font size of the text and the space available on the label. Manufacturers need to determine the proper distance to view the safety label and avoid the hazard. ANSI has a set of font size guidelines that can be referenced for this very purpose.
When designing a safety label, ANSI standards indicate it can be laid out in either a vertical or horizontal format. Both orientations are acceptable design layouts and can be determined by a manufacturer’s corporate standards, the area where the label will go, or personal preference.
It is also a good practice to keep layout styles consistent across different labels. Generally, manufacturers want to keep the signal word panel, the pictorials, and the verbiage in the same location within various labels when possible. This will allow end users to recognize safety messages quickly.
Final Label Design and Production
After the label passes the test, work with a proven label supplier to produce the finished product, making certain to provide size requirements and any special instructions to the supplier. In addition, while there are no set standards for the type of material on which the label should be printed, there are special conditions that should be considered by the manufacturer. It is recommended to inform the supplier if the label will be exposed to extreme conditions, such as abrasion or chemicals.
All of these factors will play a role in determining which adhesive, base material, and over-laminate (if applicable) are best to use. Other items to be addressed with the supplier are the surface to which the label is being applied:
For additional information on the technologies and products discussed in this article, see MDT online at www.mdtmag.com or Standard Register at www.standardregister.com.