Glossary

use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour

Note 1: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and professional users.
Note 2: Reasonably foreseeable misuse can be intentional or unintentional.

[ISO 14971:2019]

any measure aimed at achieving the return of a device that has already been made available to the end user

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

a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.  Recall does not include a market withdrawal or a stock recovery.

[FDA 21CFR7]

document stating results achieved or providing evidence of activities performed

[ISO 9000:2015, ISO 14971:2019]

government agency or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and can take legal action to ensure that medical devices marketed within its jurisdiction comply with legal requirements

[ISO 20916:2019]

 

obligatory requirement specified by an authority mandated by a legislative body

[ISO 9000:2015]

[organization that] changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

[FDA website: Who Must Register...]

any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use

[FDA 21CFR820, FDA website: Who Must Register...]

[organization that] packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers)

[FDA website: Who Must Register...]

action on a nonconforming product or service to make it acceptable for the intended use

Note 1: A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the requirements. It can be that in conjunction with a repair a concession is required.
Note 2: Repair includes remedial action taken on a previously conforming product or service to restore it for use, for example as part of maintenance.
Note: Repair can affect or change parts of the nonconforming product or service.

[ISO 9000:2015 ]

condition of measurement, out of a set of conditions that includes the same measurement procedure, same operators, same measuring system, same operating conditions and same location, and replicate measurements on the same or similar objects over a short period of time

[ISO 11139:2018]

A measure of how well one can obtain the same observed value when measuring the same part or sample over and over using the same measuring device

Note: Repeatability is sometimes referred to as equipment variation, or EV.

[Crossley, 2000]

an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.

Note 1: A single-use device that meets the definition under clause (A) shall be considered a reprocessed device without regard to any description of the device used by the manufacturer of the device or other persons, including a description that uses the term "recycled" rather than the term "reprocessed".
Note 2: The term "original device" means a new, unused single-use device.
Note 3: The term "critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.
Note 4: The term "semi-critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.

[OLRC 21USC9]

validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization

[FDA guidance: Reprocessing Medical Devices...(2017), FDA guidance: Deciding When to Submit...(2014)]

a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device

[EU MDR 2017/745]

[organization that] performs remanufacturing operations on a single-use device

[FDA website: Who Must Register...]

How well others agree with our measurement when measuring the same sample using the same measuring device

Note: Reproducibility is sometimes referred to as appraiser variation, or AV.

[Crossley, 2000]

condition of measurement, out of a set of conditions that includes different locations, processors, measuring systems, and replicate measurements on the same or similar objects

[ISO 11139:2018]

risk remaining after risk control measures have been taken

[ISO 14971:2019]

a device intended for repeated use either on the same or different patients, with appropriate cleaning and other reprocessing between uses

[FDA guidance: Deciding When to Submit...(2014), FDA guidance: Reprocessing Medical Devices...(2017)]

medical device designated or intended by the manufacturer as suitable for processing and reuse

[ISO 11139:2018]

income generated from normal business operations including discounts and deductions for returned merchandise

Note: Revenue is the top line or gross income figure from which costs are subtracted to determine net income.

[Investopedia]

action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution

[FDA 21CFR820]

action on a nonconforming product or service to make it conform to the requirements

[ISO 9000:2015]

combination of the probability of occurrence of harm and the severity of that harm

[ISO 14971:2019, ISO 13485:2016]

effect of uncertainty on objectives

Note 1: An effect is a deviation from the expected. It can be positive, negative or both, and can address, create or result in opportunities and threats.
Note 2: Objectives can have different aspects and categories, and can be applied at different levels.
Note 3: Risk is usually expressed in terms of risk sources, potential events, their consequences and their likelihood.

[ISO 31000:2018]

systematic use of available information to identify hazards and to estimate the risk

[ISO 14971:2019]

overall process comprising a risk analysis and a risk evaluation

[ISO 14971:2019]

process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels

[ISO 14971:2019]

measure implemented by which a risk is reduced to, or maintained within, a specified level

Note: Risk control measures can be divided into two categories:
1. Existing risk control measures - risk control measures that already exist within the design (product and operations processes)
2. Additional risk control measures - new risk control measures identified during risk control option analysis

process used to assign values to the probability of occurrence of harm and the severity of that harm

[ISO 14971:2019]

process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk

[ISO 14971:2019]

systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk

[ISO 14971:2019, ISO 13485:2016]

designated group of subject matter experts and managers who have responsibility for the supervision of all risk management activities at a manufacturer including authorization to balance benefits against residual risks to make final decisions regarding the acceptability of overall residual risk

set of records and other documents that are produced by risk management

[ISO 14971:2019]

overall plan for risk management activities for the particular medical device under consideration

a summary of the review of the final results of the risk management process for the particular medical device under consideration

persons performing risk management tasks

matrix that graphically displays risk regions and risk levels

instance where one risk has been allowed to increase in order that another risk could be reduced

Example: The risk to one person (the user) is allowed to increase so that the risk to another (the patient) can be reduced.

[ISO/TR 24971:2013 derived]

main risk management summary table for documenting risk analysis, risk evaluation, and risk control activities

any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing

[FDA 21CFR806]