ISO 15004-2:2024 眼科用機器 — 基本的な要件と試験方法 — Part 2:光障害に対する保護 | ページ 6

3.1

aperture

aperture stop

opening that defines the area over which average optical emission is measured

Note 1 to entry: For spectral irradiance measurements this opening is usually the entrance of a small integrating sphere placed in front of the radiometer/spectroradiometer entrance slit.

3.2

continuous exposure

continuous wave

CW

radiant exposure equal to or greater than 0,25 s duration

3.3

continuous wave instrument

CW instrument

ophthalmic instrument that is designed to expose the eye to one or more continuous wave radiation sources

3.4

continuous wave radiation source

CW radiation source

radiation source that is, or can be, operated with a continuous output for a time that can be equal or greater than 0,25 s (i.e. a non-pulsed radiation source)

3.5

dose-limited instrument

ophthalmic instrument whose emission could exceed the Group 1 exposure limits, but through its design and construction and accounting for multiple exposures within a 24-hour period, cannot under reasonably foreseeable conditions expose any given eye to radiation that exceeds the Group 1 cumulative exposure limits given in Table 2 and Table 3

Note 1 to entry: This instrument would otherwise be a Group 2 instrument; for example, some UV-Fluorescent diagnostic instruments.

Note 2 to entry: The maximal exposure duration of dose-limited instruments is 30 000 s.

3.6

effective aperture

portion of the aperture that limits the amount of light delivered to the retina

Note 1 to entry: For an obscured or noncircular aperture, the effective aperture is defined as the uniformly illuminated, unobscured circular aperture that transmits the same radiant flux.

3.7

emission limit

maximum permitted value of optical radiation output to which the eye is potentially exposed

3.8

exposure limit

maximum permitted value of optical radiation exposure to which an ocular tissue is potentially exposed

3.9

endoilluminator

instrument consisting of a light source and an associated fibre optic light guide that is intended for insertion into the eye to illuminate any portion of the interior of the eye

3.10

field-of-view

conical solid angle as “seen” by the detector, such as the eye or the radiometer/spectroradiometer, over which the detector receives radiation

Note 1 to entry: This is also referred to as acceptance angle.

Note 2 to entry: The field-of-view denotes the angle over which radiance is averaged (sampled) and should not be confused with the angular subtense of the source α, which denotes source size.

Note 3 to entry: In this document, a plane angle is used to describe a circular symmetric solid angle field of view.

3.11

group 1 instrument

ophthalmic instrument for which no potential optical radiation hazard exists and that can be shown to fulfil Group 1 requirements

3.12

group 2 instrument

ophthalmic instrument for which a potential optical radiation hazard exists and that does not fulfil Group 1 requirements but does fulfil the Group 2 requirements

Note 1 to entry: Since Group 2 instruments do not fulfil the requirements of Group 1 instruments, special precautions are necessary.

3.13

immobilized eye

eye that is physically fixed or whose movements are compensated so that a retinal image does not move.

Note 1 to entry: For the purpose of this document, this term also refers to a retinal image stabilized by eye tracking technology. It does not refer to an eye that is maintaining voluntary fixation, e.g. during an ophthalmic examination.

3.14

irradiance

E

Note 1 to entry: Irradiance is expressed in units of watts per square centimetre, W/cm².

3.15

manufacturer

natural or legal person with responsibility for design or manufacture of an ophthalmic instrument with the intention of making the ophthalmic instrument available for use, under their name, whether or not such an ophthalmic instrument is designed or manufactured by that themselves or on their behalf by another person

[SOURCE:ISO 13485:2016, 3.10, modified — The word"medical device" has been replaced by"ophthalmic instrument", neutered.]

3.16

maximum intensity

highest optical radiation intensity the instrument can deliver under normal conditions

3.17

operation microscope

stereo microscope used for observation of surgical and other medical procedures, consisting of an illumination system and an observation system

3.18

optical radiation hazard

hazard related to the risk of damage to the eye by exposure to optical radiant energy

3.19

pulse duration

time interval equal to the full width at half maximum of the pulse

3.20

pulsed instrument

ophthalmic instrument that emits radiation in the form of a single exposure of known duration of less than 0,25 s or a train of pulses where each pulse in that train has a duration of less than 0,25 s

Note 1 to entry: A continuous train of pulses or modulated radiant energy where the peak radiated power is at least ten times the minimum radiated power is considered to be pulsed radiation.

3.21

radiance

L

Note 1 to entry: The same definition holds for the time-integrated radiance L_t if, in the equation for L, the radiant power dΦ is replaced by the radiant energy dQ.

Note 2 to entry: Radiance is expressed in watts per steradian square centimetre, W/(sr⋅cm²); time-integrated radiance is expressed in Joules per steradian square centimetre, J/(sr⋅cm²).

3.22

radiant exposure

H

Note 1 to entry: Radiant exposure is expressed in Joules per square centimetre, J/cm².

3.23

recommended maximum exposure

RME

group 2 radiant exposure value above which a substantial risk of permanent injury exists

Note 1 to entry: Added precautions are recommended.

3.24

scanning instrument

instrument that emits radiation having a time-varying direction, origin or pattern of propagation with regard to a stationary frame of reference

3.25

slit-lamp microscope

instrument consisting of a microscope and a swivelling illumination system providing a slit image

3.26

spectral irradiance

E_λ

Note 1 to entry: Spectral irradiance is expressed in watts per square centimetre nanometre, W/(cm²·nm).

3.27

spectral radiance

L_λ

Note 1 to entry: Spectral radiance is expressed in watts per steradian square centimetre nanometre, W/(sr⋅cm²⋅nm).

3.28

spectral radiant exposure

H_λ

Note 1 to entry: Spectral radiant exposure is expressed in joules per square centimetre nanometre, J/(cm²⋅nm).

3.29

spot size

full-width half-maximum values of the dimension of an irradiated area

3.29.1

small spot

spot with a spot size ≤0,03 mm

Note 1 to entry: This applies where the minimum and maximum dimensions are less than or equal 0,03 mm.

3.29.2

intermediate spot

spot with at least one dimension between spot size >0,03 mm and <1,7 mm

Note 1 to entry: For the irradiated area with a non-circular cross-section, the value of spot size shall be determined by averaging the maximum and minimum cross-section lengths with the exception that where one dimension is greater than 1,7 mm, 1,7 mm is used for the averaging, the values are limited to no more than 1,7 mm and no less than 0,03 mm.

3.29.3

large spot

spot with a spot size ≥1,7 mm

Note 1 to entry: This applies where the minimum and maximum dimensions are both greater than or equal 1,7 mm.

3.30

time-limited instrument