Page 189 - Safety Risk Management for Medical Devices

168 Safety Risk Management for Medical Devices

usually English, and then translated to other languages. The problem is that not all
concepts can be directly translated from one language to another. Here are some
examples of potential sources of confusion in translations:

English: Bend the wire into a J, or hockey stick shape
Problem: Many languages don’t have the letter J. Many cultures are unfamiliar with
hockey.
English: When the alarm goes off do .. .
Problem: Does this mean when the alarm begins, or when the alarm ends?

Sometimes a translated word has one connotation in one geography, and another
in a different geography. French in France is not the same as French in Canada;
Portuguese in Portugal is not the same as Portuguese in Brazil, and English in the
United States is not the same as English in the United Kingdom. For example:
First Floor
United States: Ground floor
United Kingdom: the floor above the ground floor
Chips
United States: Thinly sliced, deep-fried, baked, or kettle-cooked crunchy potatoes
(crisps in the United Kingdom)
United Kingdom: Cut and deep-fried potatoes

Another element of the guidance from Guide 51 [1] is conciseness and unambigu-
ity. This is a challenge for technical writers, particularly with respect to product label-
ing and screen user interfaces where space is limited.
As stated earlier, an important requirement for information for safety is that it
must be demonstrated to be effective. This demonstration is typically done as part of
summative usability testing. Through objective evidence, it must be shown that users
will refer to, comprehend, and use the information for safety, such that it produces
the expected reduction in risk.

18.5 SAMPLE RISK CONTROLS

Risk Controls should be a narrative to a specific action. Each Risk Control can be
implemented via various means, such as System Requirements, operating procedures,
and conformance to recognized standards. Some example Risk Controls that can be
used as models are as follows:

• The device is designed to withstand up to 10 N of tensile pull-force
• The GUI is designed to minimize erroneous button pushes