ISO 10555-1:2023 カテーテル内の血管 | ページ 5

3.1

intravascular catheter

tubular device, single or multilumen, designed to be partially or totally inserted or implanted into the vascular system for diagnostic and/or therapeutic purposes

3.2

distal end

end of the catheter inserted furthest into the patient

3.3

distal end configuration

shape of the catheter which is designed to facilitate its manual manipulation through the vascular system and the placement and anchoring of the distal tip in the chosen location

3.4

proximal end

access end

end of the catheter to which connection to another device can be made

3.5

hub

connector(s) at the proximal end (3.4) of the catheter which can either be integral with the catheter or be capable of being securely fitted to the proximal end (3.4) of the catheter

3.6

effective length

working length

usable length

length of the catheter, or pre- and post-hydration (3.11) lengths of hydratable catheters, that can be inserted into the body

Note 1 to entry: See Figure 1 where"l" is denoted as effective length.

Figure 1 — Examples of effective length of catheters

Key

l	effective length
1	catheter hub
2	catheter strain reinforcement
3	length mark
4	junction
5	pre-connected port
6	sidearm

3.7

outside diameter

largest diameter of the catheter or pre- and post-hydration (3.11) largest diameters of hydratable catheters over the effective length (3.6)

3.8

inside diameter

largest diameter that can pass through a catheter lumen intended to deliver other devices

Note 1 to entry: See Annex J for additional information.

3.9

junction

joint

fixed connection

joining of one tube or more tubes with another tube or component where the assembly provides mechanical support in tension/compression during clinical use

3.10

hydratable intravascular catheter

intravascular catheter consisting of a material which, when subjected to an aqueous medium, results in an increase of more than 1 % of the effective length or 10 % or more of the outside diameter (3.7) of the effective length in post-hydration (3.11) state compared to pre-hydration

3.11

post-hydration

state of a hydratable intravascular catheter (3.10) after immersion in aqueous medium at (37 ± 2) °C for a minimum of 2 h or a shorter time upon appropriate clinical justification

3.12

power injection

injection of an imaging contrast agent with a constant-pressure source or constant-flowrate source capable of generating pressures greater than or equal to 689 kPa

3.13

primary packaging

packaging, which has direct contact with the device and/or maintains sterility

3.14

secondary packaging

packaging designed to contain one or more primary packages (3.13) and/or accessories

3.15

gauge length

length of the test piece between the grips of the tensile testing apparatus that elongates significantly during testing

Note 1 to entry: See Figure B.1.

Note 2 to entry: See Annex J for additional information.

3.16

coating

substance or material with any different property (e.g. antimicrobial, lubricity, antithrombogenicity) than the natural surface of the substrate that is intentionally added to cover the substrate

Note 1 to entry: The coating can partially or fully cover the substrate surface. Liquid lubricant is not considered as coating.