1. User Environment Requirements HE75 (information only RY)
User Environment Profile is a description of representative user and use environment with specific
characteristics that can be a bearing on design decision or can cause possible misuse of product that
results in user and patient safety and hazard issues.
IEC60601-1-6 describes that the Use Environment profile shall record the Summary of spatial
context (architecture, outside, technological setting, emergency location, etc), physical context
(climate, daytime, light,etc), and other characteristics of each potential use environment
(conditions of visibility, physical – temperature, humidity, ambient pressure, background noise).
The following is the list of use environment information that must be understood and described in
compliance with IEC60601-1-6. Any additional information that are not reflected in this template
should be described by each program team as long as the information will help evaluating the risk
associated with a particular design concepts or design decisions.
5.5 Defining the use environment involves the following steps:
a) Identify environmental characteristics. Environment-of-use characteristics should be included in
preliminary design considerations and use-error risk management assessment. The environment in
which a device is used (e.g., OR, hospital bed, home) can affect the actual use of the device
(see Section 8, “Environmental considerations”) because of variations in conditions such as noise,
lighting, and temperature. For example,background noise in an OR could prevent users from hearing
critical alarm signals.
b) Consider dynamic ambient conditions. The conditions of use can change in a given use environ-
ment according to time of day, patient load, and type of care given in the environment. For example,
the readability of displays in the low lighting of a patient room at night might differ from that in the
same room in bright daylight. The accessibility of critical display information or controls in a busy
emergency room could be vastly different from that in a patient room on the hospital floor. The dynam-
ics of patient load in the use environment can also create periods of stress and high workload that
could increase the likelihood of use errors (5.6.5).
c) Consider worst-case use environments. If errors are more likely under certain use conditions, those
conditions should, to the extent possible, be considered carefully or simulated in user-based testing.
12.2.3 The use environment
Similar medical devices are used differently in the home environment than in a clinical environment. In
some cases, the same device should be packaged differently for different use environments. Differ-
ences in use environments can affect the design, storage, use, maintenance, disposal, and other as-
pects of a device’s packaging. For example, hospitals typically have access to package-opening tools
that home users do not have. Even within clinical environments, there are sterile and nonsterile condi-
tions that must be taken into account.
Certain medical devices, such as arterial stents and laparoscopic tools, are used in specific, well-con-
trolled clinical environments. Other devices, such as syringes, blood glucose test strips, and other dis-
posables, are used in a variety of environments by a broad range of users and under varying circum-
stances. Still other devices must be used in environments that vary dramatically in levels of lighting,
noise, temperature, and movement. For example: a) Sterile clinical environments will, in general, have
good lighting conditions.
b) Nonsterile clinical environments will, in general, have varied lighting conditions.
c) Home environments will, in general, have more varied lighting conditions and are not sterile.
13.2.2 Type of use environment: health care facility or home
Medical devices could be intended for use in either a clinical environment (e.g., a hospital, clinic, or
professional medical practice) or in non-professional settings. From a human factors perspective, us-
ing a medical device in the home environment is distinctly different from using the same or a similar
device in a clinical environment. Health care facilities have resources at their disposal that are not
available to lay users. An obvious example is the availability of trained technicians who can diagnose
device problems and make repairs. Devices intended for use in the home should provide self-dia-
gnostics or remote diagnostics.

2. Certain guidelines in this section distinguish between devices intended for use in a health care facility
and those intended for use in a home. Typically, devices intended for use in a health care facility are
used by health care professionals, whereas those intended for use at home are used by lay users. For
information regarding the design of devices for home use, see Section 25, “Home health care.”
25.3.5.1 Conditions and environment of use
In addition to the design considerations related to the capabilities and limitations of the typical users of
home health care devices, design considerations related to the conditions and environment of use
should be taken into account.
These considerations include issues related to security, maintenance of devices, and the use of dis-
posable components.