Glossary

freedom from unacceptable risk

[ISO 14971:2019]

Note: Safety can be divided into two parts:
1. Clinical safety - safety from clinical complications
2. Technical safety - safety from medical device hazards

action on a nonconforming product or service to preclude its originally intended use

Example: Recycling, destruction.
Note: In a nonconforming service situation, use is precluded by discontinuing the service.

[ISO 9000:2015]

protection of information and data so that unauthorized persons or systems cannot read or modify them and authorized persons or systems are not denied access to them

[IEC 62304:2015]

a condition that results from the establishment and maintenance of protective measures that ensure a state of inviolability from hostile acts or influences, where hostile acts or influences could be intentional or unintentional

[ISO/TR 24971:2020]

injury or illness that:
a) is life threatening,
b) results in permanent impairment of a body function or permanent damage to a body structure, or
c) necessitates medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure

[FDA 21CFR803]

output of an organization with at least one activity necessarily performed between the organization and the customer

Note 1: The dominant elements of a service are generally intangible.
Note 2: Service often involves activities at the interface with the customer to establish customer requirements as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospitals.
Note 3: Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (e.g. a car to be repaired);
— an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
— the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
— the creation of ambience for the customer (e.g. in hotels and restaurants);
Note 4: A service is generally experienced by the customer.

[ISO 9000:2015]

process of combining various inputs in order to maintain or repair a medical device such that it is ready for use

measure of the possible consequences of a hazard

[ISO 14971:2019]

a device that is intended for one use, or on a single patient during a single procedure

[OLRC 21USC9]

a device that is intended to be used on one individual during a single procedure

[EU MDR 2017/745]

a device that is intended to be used during a single procedure

[EU IVDR 2017/746]

medical device labelled or intended to be used on one individual during a single procedure

[ISO 11139:2018]

The set of electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical device, or to provide the actions of a medical device. This definition includes software that is embedded within or permanently a component of a medical device, software that is an accessory to another medical device, or software that is intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.

[FDA guidance: Deciding When to Submit...(2014)]

software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device

Notes:
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
• SaMD is capable of running on general purpose (non-medical purpose) computing platforms
• “without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
• SaMD may be used in combination (e.g., as a module) with other products including medical devices;
• SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD.

[IMDRF/SaMD WG/N10:2013, IMDRF/SaMD WG/N12:2014]

any identifiable part of a computer program, i.e., source code, object code, control code, control data, or a collection of these items

Note: Three terms identify the software decomposition. The top level is the software system. The lowest level that is not further decomposed is the software unit. All levels of composition, including the top and bottom levels, can be called software items. A software system, then, is composed of one or more software items, and each software item is composed of one or more software units or decomposable software items. The responsibility is left to the manufacturer to provide the granularity of the software items and software units.

[IEC 62304:2015]

integrated collection of software items organized to accomplish a specific function or set of functions

[IEC 62304:2015]

software item that is not subdivided into other items

Note: The granularity of software units is defined by the manufacturer

[IEC 62304:2015]

any requirement with which a product, process, service, or other activity must conform

[FDA 21CFR820]

[organization that] develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing.  This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

[FDA website: Who Must Register...]

person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity

Note: The term “interested party” can be used as an alternative to “stakeholder”.

[ISO 31000:2018]

developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience

Note: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine.  The state of the art does not necessarily imply the most technologically advanced solution.  The state of the art described here is sometimes referred to as the “generally acknowledged state of the art”.

[ISO 14971:2019]

free from viable microorganisms

[ISO 11139:2018]

medical device intended to meet the requirements for sterility

Note: The requirements for sterility of a medical device can be subject to applicable regulatory requirements or standards.

[ISO 13485:2016]

validated process used to render a product free from viable microorganisms

Note: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero.

[ISO 11139:2018]

the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use

[FDA 21CFR806]

a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.  A subject may be in normal health or may have a medical condition or disease.

[FDA 21CFR812]

human who participates in a clinical performance study or whose specimen is used in the study

Note: Depending on the study, a subject can be either a healthy individual or a patient.

[ISO 20916:2019]

an individual who participates in a clinical investigation

[EU MDR 2017/745]

an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes

[ISO 20916:2019]

individual who is or becomes a participant in a clinical investigation, either as a recipient of the investigational device or a comparator

Note: This includes healthy volunteers.

[ISO 14155:2020]

Substantial equivalence means that the new device is at least as safe and effective as the predicate.  A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device.

Note 1: A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and has the same technological characteristics as the predicate; or has the same intended use as the predicate; and has different technological characteristics and does not raise different questions of safety and effectiveness; and the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.
Note 2: A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
Note 3: A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may: resubmit another 510(k) with new data, request a Class I or II designation through the De Novo Classification process, file a reclassification petition, or submit a premarket approval application (PMA).

[FDA website: Premarket Notification 510(k)]