Glossary

an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter

[FDA 21CFR801, FDA 21CFR803, FDA 21CFR806, FDA 21CFR810, FDA 21CFR814, FDA 21CFR820, FDA 21CFR821, FDA 21CFR822, FDA 21CFR830]

a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market

[EU MDR 2017/745, EU IVDR 2017/746]

[organization that] manufactures medical devices that are not sold in the US and are manufactured solely for export to foreign countries

[FDA website: Who Must Register...]

characteristic of the user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment

Note: All aspects of usability, including effectiveness, efficiency and user satisfaction, can either increase or decrease safety.

[IEC 62366-1:2015]

application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability

Note 1: Achieving adequate usability can result in acceptable risk related to use.

[IEC 62366-1:2015]

Note 2: Also known as human factors engineering (HFE)

set of records and other documents that are produced by the usability engineering process

[IEC 62366-1:2015]

method for exploring or evaluating a user interface with intended users within a specified intended use environment

[IEC 62366-1:2015]

actual conditions and setting in which users interact with the medical device

Note: The conditions of use or attributes of the use environment can include hygienic requirements, frequency of use, location, lighting, noise, temperature, mobility, and degree of internationalization.

[IEC 62366-1:2015]

user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user

Note 1: Use error includes the inability of the user to complete a task.
Note 2: Use errors can result from a mismatch between the characteristics of the user, user interface, task, or use environment.
Note 3: USERS might be aware or unaware that a use error has occurred.
Note 4: An unexpected physiological response of the patient is not by itself considered use error.
Note 5: A malfunction of a medical device that causes an unexpected result is not considered a use error.
Note 6: The figure below shows the relationships of the types of use.

[IEC 62366-1:2015, ISO 14971:2019]

any healthcare professional or lay person who uses a device

[EU MDR 2017/745, EU IVDR 2017/746]

most IVD medical devices have two users that need to be considered:
- a user who performs all or part of an examination (“analytical use”); and
- a clinician who receives, interprets and acts on the examination results (“clinical use”).

Note: In the case of IVD medical devices intended for self-testing, the patient can be the only user.

[ISO/TR 24971:2020]

person interacting with (i.e. operating or handling) the medical device

Note 1: There can be more than one user of a medical device.
Note 2: Common users include clinicians, patients, cleaners, maintenance and service personnel.

[IEC 62366-1:2015]

means by which the user and the medical device interact

Note 1: Accompanying documentation is considered part of the medical device and its user interface.
Note 2: User interface includes all the elements of the medical device with which the user interacts including the physical aspects of the medical device as well as visual, auditory, tactile displays and is not limited to a software interface.
Note 3: For the purposes of this standard, a system of medical devices can be treated as a single user interface.

[IEC 62366-1:2015]

functions and characteristics of the medical device necessary to address the needs of the medical device user, patient, and other customers

Note: "Other customers" include other people who interact with the medical device during use and stakeholders who do not directly interact with the medical device such as post-production monitoring personnel, administrative personnel, regulatory bodies, and business stakeholders.

summary of the mental, physical and demographic traits of an intended user group, as well as any special characteristics, such as occupational skills, job requirements and working conditions, which can have a bearing on design decisions

[IEC 62366-1:2015]