ISO 23217:2024 小児患者による自己投与のための注射システム | ページ 6

3.1

accompanying documentation

materials accompanying a medical device and containing information for the user (3.15) or those accountable for the installation, use and maintenance of the medical device, particularly regarding safe use

Note 1 to entry: The accompanying documentation can consist of the instructions for use (3.8) , technical description, installation manual, quick reference guide, etc.

Note 2 to entry: Accompanying documentation is not necessarily a written or printed document but can involve auditory, visual, or tactile materials and multiple media types.

Note 3 to entry: Medical devices that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction.

[SOURCE:ISO 14971:2019, 3.1, modified —"decommissioning and disposal" have been deleted from the definition, and Note 3 to entry has been added.]

3.2

caregiver

non-professionals (e.g. family members, parents, guardians or friends) who provide care to the patient (3.11)

3.3

drug delivery system

medical device or system whose primary purpose is the administration of a medicinal product such as drugs and biologics

Note 1 to entry: This term applies to combination of components and subassemblies of the system that are intended to be integrated with the medicinal product with the purpose of providing a method of administration of the medicinal product.

[SOURCE:ISO 20069:2019, 3.1.2]

3.4

harm

injury or damage to the health of people, or damage to property or the environment

3.5

hazard

potential source of harm (3.4)

[SOURCE:ISO/IEC Guide 63:2019, 3.2]

3.6

health care provider

healthcare professional with proficient skills and experience with the use of a device so that they can aid or train patients and caregivers (3.2) to use and maintain the device

3.7

usability engineering

human factors engineering

UE/HFE

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 (3.13)

Note 1 to entry: Achieving adequate usability can result in acceptable risk (3.19) related to use.

[SOURCE:IEC 62366-1:2015, 3.17]

3.8

instructions for use

IFU

directions provided by the manufacturer for the correct handling and operation of the drug delivery system (3.3)

[SOURCE:ISO 11608-1:2022, 3.10, modified — “needle-based injection system” replaced with “drug delivery system”.]

3.9

intended use

use specification

intended purpose

use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer

Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with, user profile (3.17) , use environment, and operating principle are typical elements of the intended use.

[SOURCE:ISO/IEC Guide 63:2019, 3.4, modified — the preferred terms"use specification" and"intended purpose" have been added.]

3.10

paediatric

relating to children and/or adolescents

Note 1 to entry: The definition of paediatric varies by region and organization. See Annex A for different organizations’ classifications of “child” and “adolescent”.

3.11

patient

person undergoing a medical, surgical, or dental procedure

3.12

self-administration

process by which the patient (3.11) enters medication into their own body

3.13

usability

characteristic of the user interface (3.16) that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment

Note 1 to entry: All aspects of usability, including effectiveness, efficiency, and user satisfaction, can either increase or decrease safety.

[SOURCE:IEC 62366-1:2015, 3.16]

3.14

use error

user (3.15) action or lack of user action while using the medical device that leads to a different result than intended by the manufacturer or expected by the user

Note 1 to entry: Use error includes the inability of the user to complete a task.

Note 2 to entry: Use errors can result from a mismatch between the characteristics of the user, user interface (3.16) , task, or use environment.

Note 3 to entry: Users can be aware or unaware that a use error has occurred.

Note 4 to entry: An unexpected physiological response of the patient (3.11) is not by itself considered use error.

Note 5 to entry: A malfunction of a medical device that causes an unexpected result is not considered a use error.

[SOURCE:IEC 62366-1:2015, 3.21, modified — Note 6 to entry has been deleted.]

3.15

user

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

Note 1 to entry: There can be more than one user of a medical device.

Note 2 to entry: Common users include clinicians, health care providers (3.6) , patients (3.11) , caregivers (3.2) .

[SOURCE:IEC 62366-1:2015, 3.24, modified — Note 2 to entry has been changed.]

3.16

user interface

means by which the user (3.15) and the medical device interact

Note 1 to entry: User interface includes all the elements of the medical device with which the user interacts including accompanying documentation (3.1) , packaging, and the physical aspects of the medical device as well as visual, auditory, tactile displays and is not limited to a software interface.

Note 2 to entry: A system of medical devices can be treated as a single user interface.

[SOURCE:IEC 62366-1:2015, 3.26, modified — Note 1 to entry has been deleted.]

3.17

user profile

summary of the mental, physical and demographic traits of a user (3.15) group, as well as characteristics, such as knowledge, skills and abilities, which can have a bearing on design decisions

[SOURCE:IEC 62366-1:2015/Amd 1:2020, 3.29]

3.18

residual risk

risk (3.19) remaining after risk control (3.21) measures have been implemented

[SOURCE:ISO/IEC Guide 63:2019, 3.9]

3.19

risk

combination of the probability of occurrence of harm (3.4) and the severity of that harm

[SOURCE:ISO/IEC Guide 63:2019, 3.10, modified — Note 1 to entry deleted.]

3.20

risk analysis

systematic use of available information to identify hazards (3.5) and to estimate the risk (3.19)

[SOURCE:ISO/IEC Guide 63:2019, 3.11]

3.21

risk control

process in which decisions are made and measures implemented by which risks (3.19) are reduced to, or maintained within, specified levels

[SOURCE:ISO/IEC Guide 63:2019, 3.12]

3.22

risk evaluation

process of comparing the estimated risk (3.19) against given risk criteria to determine the acceptability of the risk

[SOURCE:ISO/IEC Guide 63:2019, 3.14]