ISO/IEC Guide 63:2019 医療機器の国際規格における安全性の側面の開発と包含に関するガイド | ページ 6

3.1

harm

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

[SOURCE:ISO/IEC Guide 51:2014, 3.1]

3.2

hazard

potential source of harm (3.1)

[SOURCE:ISO/IEC Guide 51:2014, 3.2]

3.3

hazardous situation

circumstance in which people, property or the environment is/are exposed to one or more hazards (3.2)

[SOURCE:ISO/IEC Guide 51:2014, 3.4]

3.4

intended use

use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer (3.6)

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.

3.5

life cycle

series of all phases in the life of a medical device (3.7) , from the initial conception to final decommissioning and disposal

3.6

manufacturer

natural or legal person with responsibility for design and/or manufacture of a medical device (3.7) with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)

Note 1 to entry: This"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 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” can 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 (3.4) 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 authorized 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:GHTF/SG1/N055:2009, 5.1, modified - The words"may include" have been replaced with"can include" in Note 3 to entry.]

3.7

medical device

[SOURCE:GHTF/SG1/N071:2012, 5.1, modified — The words"may be assisted" have been replaced with"can be assisted" in the definition, and the words"may be considered" have been replaced with"can be considered" in Note 1 to entry.]

3.8

reasonably foreseeable misuse

use of a product or system in a way not intended by the manufacturer (3.6) , 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 51:2014, 3.7, modified — The word “supplier” has been replaced with “manufacturer”, the example in Note 1 to entry has been modified, and Note 2 to entry has been replaced with a new Note to entry.]

3.9

residual risk

risk (3.10) remaining after risk control (3.12) measures have been implemented

[SOURCE:ISO/IEC Guide 51:2014, 3.8, modified — The words “risk reduction measures” have been replaced with “risk control measures”.]

3.10

risk

combination of the probability of occurrence of harm (3.1) and the severity (3.17) of that harm

Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation (3.3) and the possibility to avoid or limit the harm.

[SOURCE:ISO/IEC Guide 51:2014, 3.9, modified — The words"the occurrence of a hazardous event" have been removed from Note 1 to entry.]

3.11

risk analysis

systematic use of available information to identify hazards (3.2) and to estimate the risk (3.10)

[SOURCE:ISO/IEC Guide 51:2014, 3.10]

3.12

risk control

process in which decisions are made and measures implemented by which risks (3.10) are reduced to, or maintained within, specified levels

3.13

risk estimation

process used to assign values to the probability of occurrence of harm (3.1) and the severity (3.17) of that harm

3.14

risk evaluation

process of comparing the estimated risk (3.10) against given risk criteria to determine the acceptability of the risk

3.15

risk management

systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk (3.10)

3.16

safety

freedom from unacceptable risk (3.10)

3.17

severity

measure of the possible consequences of a hazard (3.2)

3.18

state of the art

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 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 2:2004, 1.4, modified — Note 1 to entry has been added.]

3.19

verification

confirmation, through the provision of objective evidence, 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 9000:2015, 3.8.12]