Guidance on Medical Device Patient Labeling:- Appendix C

Appendix C

Appearance of text:

What principles should be applied to the physical features of the text?

The speed by which letters and words can be recognized (legibility) can be enhanced by applying the following principles.

Sections:

Divide the text appropriately into short sections. Use headings or other highlighting/separation devices. Major headings, including captions and subtitles, should capture the main points. Within the text, bullet text is helpful.

When creating headings, it is acceptable to use uppercase letters and bold print.

Type:

Base the type size and font on the needs of the target audience.

Use at least a 12 point type size whenever possible. For elderly or visually impaired users, use at least 14 points. For headings, use ranges from 18-36 points.

Use a serif font for the text. It allows more variation among letters than sans serif. This makes the letters easier to recognize.

Use both upper and lower case letters in the body of the text. It is more difficult to read all capital letters.

Use black type on a white background for best contrast. It is the easiest to read.

Paper:

Avoid glossy paper. It may cause a glare.

Use paper heavy enough to prevent text and graphics from showing through.

Highlighting:

Use highlighting techniques to emphasize important words, thoughts, or phrases. Highlighting techniques include bolding, underlining, italics, capital letters, color, background patterns, and white space.

Do not overdo highlighting. It will decrease the impact of the message.

Be consistent in the highlighting methods used.

White space:

Use white space carefully to keep the medical device patient labeling from looking too cramped or too spread out. White space between blocks of text aids the ease of reading.

Justify the left-hand margin. Use ragged right margins.

Use at least 1/16^th of an inch of white space between lines of text.

Increase the amount of white space around important individual words, text and graphics for emphasis.

Formatting and organizing instructions:

Organize instructions with text, flowchart, or list formats as appropriate.

Use tables to present information graphically to simplify complex information.

• It should complement and supplement the text.
• It should condense statistical information.

Note: In instruction manuals, tables are normally not appropriate and their use should be minimized. If a table is necessary to simplify complex information, include instructions on its use. Label each table clearly.

Use lists when the use of the device requires checking off steps that are completed.

Number steps that must be completed in order.

Bullet lists that have no specific order of importance.