Page 133 - Safety Risk Management for Medical Devices

112 Safety Risk Management for Medical Devices

Table 12.11 Taxonomy of user actions
Use Scenario 1

Task 1
Step Action 1
Step Action 2
Step Action 3

Task 2
Step Action 1
Step Action 2

Use Scenario: Describes the interaction of a user with the device to achieve a cer-
tain outcome.

A Use-Scenario is comprised of one or more tasks. Each task is comprised of one
or more action steps. Table 12.11 illustrates this taxonomy.

Tip Use a verb or action phrase for Use-Scenario titles, Tasks, and Step Actions. Example: check
status; deliver shock; remove pad from package.

12.8.2 Use Specification Versus Intended Use
ISO 14971 [3] defines Intended Use as the “intended purpose; use for which a product,
process, or service is intended according to the specifications, instructions and infor-
mation provided by the manufacturer.”

IEC 62366 [14] defines Use Specification as
“summary of the important characteristics related to the context of use of the
medical device

Note 1: the intended medical indication, patient population, part of the body or
type of tissue interacted with, user profile, use environment, and operat-
ing principle are typical elements of the use specification.
Note 2: the summary of the medical device use specification is referred to by
some authorities having jurisdiction as the “statement of intended use.”
Note 3: to entry: the use specification is an input to determining the intended
use of ISO 14971:2007.”

While “Intended Use” and “Use Specification” are similar, they are not the same
thing. Intended Use is akin to the clinical indication of the medical device—what