ISO 10993-17:2002 医療機器の生物学的評価—パート17：浸出性物質の許容限度の確立 | ページ 6

3.1

allowable limit

AL

largest amount of a leachable substance that is deemed acceptable on a daily basis, when taken into the body through exposure to a medical device

Note 1 to entry: Allowable limits are expressed in dose to the patient for each applicable exposure period. The units used are mass per unit time, e.g. milligrams per day. These doses represent tolerable risks for medical devices under the circumstances of intended use.

3.2

benefit factor

BF

numerical factor that takes into account the health benefit from use of the medical device(s) containing the leachable substance in question

3.3

concomitant exposure factor

CEF

numerical factor that accounts for patient exposure to many medical devices containing the same leachable substance

Note 1 to entry: This factor is used to adjust the product of TI and body mass downward.

3.4

default

value to be used, in the absence of data, for an uncertainty or other factor used in the calculation of the allowable limit

3.5

harm to health

physical injury and/or damage to health

3.6

health benefit

likelihood of maintaining or improving health

3.7

health hazard

potential source of harm to health

3.8

health risk

combination of the likelihood of occurrence of harm to health and the severity of that harm

3.9

health risk analysis

use of available information to identify health hazards and to estimate health risk

3.10

leachable substance

chemical removed from a medical device by the action of water or other liquids related to the use of the device

3.11

lowest observed adverse effect level

LOAEL

lowest concentration or amount of a substance found by experiment or observation which causes detectable adverse alteration of morphology, functional capacity, growth, development or life span of the target organism under defined conditions of exposure

Note 1 to entry: Alterations in morphology, functional capacity, growth, development or life span of the target organism may be detected which are judged not to be adverse.

3.12

minimally irritating level

MIL

amount of a leachable substance that is minimally irritating to the patient

Note 1 to entry: It is normally expressed in milligrams, although sometimes as milligrams per millilitre, in which case the value must be multiplied by the volume (millilitres) used to get the mass (milligrams).

3.13

modifying factor

MF

mathematical product of uncertainty factors UF₁, UF₂ and UF₃

3.14

multiple exposure

more than one exposure of the same patient to devices containing the same leachable substance, simultaneously or at different times

3.15

non-irritating level

NIL

largest amount of a leachable substance that is not irritating to the patient

Note 1 to entry: It is normally expressed in milligrams, although sometimes as milligrams per millilitre, in which case the value must be multiplied by the volume (millilitres) used to get the mass (milligrams).

3.16

no observed adverse effect level

NOAEL

greatest concentration or amount of a substance found by experiment or observation which causes no detectable adverse alteration of morphology, functional capacity, growth, development or life span of the target organism under defined conditions of exposure

Note 1 to entry: Alterations of morphology, functional capacity, growth, development or life span of the target organism may be detected which are judged not to be adverse.

3.17

physiologically based pharmacokinetic modelling

PBPK modelling

system of modelling biological effects taking into account metabolic and pharmacokinetic differences among species of animal

Note 1 to entry: Such data should be utilized whenever they are available.

3.18

proportional exposure factor

PEF

numerical factor for patient exposure to a leachable substance that accounts for the fact that a medical device is not typically utilized every day during the entire exposure category of interest

Note 1 to entry: This factor is used to adjust the product of TI and body mass upwards.

3.19

repeated use

use of the same device by the same patient more than once without reprocessing

3.20

safety

freedom from unacceptable health risk

3.21

simultaneous use

use of more than one device by the same patient at the same time

3.22

tolerable contact level

TCL

tolerable contact exposure to a leachable substance resulting from contact with a medical device

Note 1 to entry: It is normally expressed in milligrams per square centimetre of body surface.

3.23

TCL modifying factor

MF _TCL

mathematical product of uncertainty factors UF₄, UF₅ and UF₆

3.24

tolerable exposure

te

product of the tolerable intake, the body mass and the utilization factor

Note 1 to entry: It is normally expressed in milligrams per day to the patient.

3.25

tolerable intake

ti

estimate of the average daily intake of a substance over a specified time period, on the basis of body mass, that is considered to be without appreciable harm to health

Note 1 to entry: It is normally expressed in milligrams per kilogram of body mass per day. It is derived as a part of the overall establishment of allowable limits for a leachable substance in a medical device.

3.26

tolerable risk

risk which is accepted in a given context based upon the current values of society

3.27

uncertainty factor

UF

factor intended to account for the uncertainties inherent in estimating potential effects of a chemical on humans from results obtained in human populations or surrogate species

3.28

utilization factor

UTF

numerical factor used to take into account the utilization of the device in terms of frequency of use and utilization in conjunction with other medical devices that can be reasonably anticipated to contain the same leachable substance