ISO 14971:2019 医療機器—医療機器へのリスク管理の適用 | ページ 6

3.1

accompanying documentation

materials accompanying a medical device (3.10) and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device (3.10) , particularly regarding safe use

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

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

3.2

benefit

positive impact or desirable outcome of the use of a medical device (3.10) on the health of an individual, or a positive impact on patient management or public health

Note 1 to entry:Benefits can include positive impact on clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.

3.3

harm

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

[SOURCE:ISO/IEC Guide 63:2019, 3.1]

3.4

hazard

potential source of harm (3.3)

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

3.5

hazardous situation

circumstance in which people, property or the environment is/are exposed to one or more hazards (3.4)

Note 1 to entry: See Annex C for an explanation of the relationship between hazard and hazardous situation.

[SOURCE:ISO/IEC Guide 63:2019, 3.3, modified — Note 1 to entry added.]

3.6

intended use

intended purpose

use for which a product, process (3.14) or service is intended according to the specifications, instructions and information provided by the manufacturer (3.9)

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

[SOURCE:ISO/IEC Guide 63:2019, 3.4]

3.7

in vitro diagnostic medical device

IVD medical device

device, whether used alone or in combination, intended by the manufacturer (3.9) for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles

[SOURCE:ISO 18113-1:2009, 3.27, modified — NOTE deleted.]

3.8

life cycle

series of all phases in the life of a medical device (3.10) , from the initial conception to final decommissioning and disposal

[SOURCE:ISO/IEC Guide 63:2019, 3.5]

3.9

manufacturer

natural or legal person with responsibility for the design and/or manufacture of a medical device (3.10) with the intention of making the medical device (3.10) available for use, under his name, whether or not such a medical device (3.10) is designed and/or manufactured by that person himself or on his behalf by another person(s)

Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.

Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.

Note 3 to entry: “Design and/or manufacture” may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.

Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.

Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.

Note 6 to entry: An authorised representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.

Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.

[SOURCE:ISO/IEC Guide 63:2019, 3.6]

3.10

medical device

[SOURCE:ISO/IEC Guide 63:2019, 3.7]

3.11

objective evidence

data supporting the existence or verity of something

Note 1 to entry:Objective evidence can be obtained through observation, measurement, test or by other means.

[SOURCE:ISO 9000:2015, 3.8.3, modified — Note 2 to entry deleted.]

3.12

post-production

part of the life cycle (3.8) of the medical device (3.10) after the design has been completed and the medical device (3.10) has been manufactured

3.13

procedure

specified way to carry out an activity or a process (3.14)

Note 1 to entry:Procedures can be documented or not.

[SOURCE:ISO 9000:2015, 3.4.5]

3.14

process

set of interrelated or interacting activities that use inputs to deliver an intended result

Note 1 to entry: Whether the “intended result” of a process is called output, product or service depends on the context of the reference.

Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.

Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process.

[SOURCE:ISO 9000:2015, 3.4.1, modified — Notes to entry 4, 5 and 6 are deleted.]

3.15

reasonably foreseeable misuse

use of a product or system in a way not intended by the manufacturer (3.9) , but which can result from readily predictable human behaviour

Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and professional users.

Note 2 to entry:Reasonably foreseeable misuse can be intentional or unintentional.

[SOURCE:ISO/IEC Guide 63:2019, 3.8]

3.16

record

document stating results achieved or providing evidence of activities performed

Note 1 to entry:Records can be used, for example, to formalize traceability and to provide evidence of verification, preventive action and corrective action.

Note 2 to entry: Generally records need not be under revision control.

[SOURCE:ISO 9000:2015, 3.8.10]

3.17

residual risk

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

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

3.18

risk

combination of the probability of occurrence of harm (3.3) and the severity (3.27) of that harm (3.3)

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

3.19

risk analysis

systematic use of available information to identify hazards (3.4) and to estimate the risk (3.18)

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

3.20

risk assessment

overall process (3.14) comprising a risk analysis (3.19) and a risk evaluation (3.20)

[SOURCE:ISO/IEC Guide 51:2014, 3.11]

3.21

risk control

process (3.14) in which decisions are made and measures implemented by which risks (3.18) are reduced to, or maintained within, specified levels

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

3.22

risk estimation

process (3.14) used to assign values to the probability of occurrence of harm (3.3) and the severity (3.27) of that harm

[SOURCE:ISO/IEC Guide 63:2019, 3.13]

3.23

risk evaluation

process (3.14) of comparing the estimated risk (3.18) against given risk (3.18) criteria to determine the acceptability of the risk (3.18)

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

3.24

risk management

systematic application of management policies, procedures (3.13) and practices to the tasks of analysing, evaluating, controlling and monitoring risk (3.18)

[SOURCE:ISO/IEC Guide 63:2019, 3.15]

3.25

risk management file

set of records (3.16) and other documents that are produced by risk management (3.24)

3.26

safety

freedom from unacceptable risk (3.18)

[SOURCE:ISO/IEC Guide 63:2019, 3.10]

3.27

severity

measure of the possible consequences of a hazard (3.4)

[SOURCE:ISO/IEC Guide 63:2019, 3.17]

3.28

state of the art

developed stage of technical capability at a given time as regards products, processes (3.14) and services, based on the relevant consolidated findings of science, technology and experience

Note 1 to entry: 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”.

[SOURCE:ISO/IEC Guide 63:2019, 3.18]

3.29

top management

person or group of people who directs and controls a manufacturer (3.9) at the highest level

[SOURCE:ISO 9000:2015, 3.1.1, modified — “An organization” replaced by “a manufacturer”, Notes to entry deleted.]

3.30

use error

user action or lack of user action while using the medical device (3.10) that leads to a different result than that intended by the manufacturer (3.9) 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, task, or use environment.

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

Note 4 to entry: An unexpected physiological response of the patient 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 deleted.]

3.31

verification

confirmation, through the provision of objective evidence (3.11) , that specified requirements have been fulfilled

Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.

Note 3 to entry: The word “verified” is used to designate the corresponding status.

[SOURCE:ISO/IEC Guide 63:2019, 3.19]