ISO 21649:2023 医療用無針注射システム — 要件と試験方法 | ページ 6

3.1

claimed lifetime

total number of injection strokes that a needle-free injection system (3.8) , in normal use with recommended user maintenance and before manufacturer overhaul or refurbishment of parts, is expected to administer within its performance profile (3.11) specified by the manufacturer

Note 1 to entry: This number may also be expressed as a period of time (e.g. number of days, weeks, months or years) at a corresponding frequency of expected usage (e.g. number of injections per day, week, month or year).

3.2

dose chamber

enclosure that contains and is in direct contact with the pharmaceutical product, and from which the pharmaceutical product is administered to the patient by the needle-free injection system

3.3

dose accuracy

difference between the intended dose and the delivered dose

3.4

injection mechanism

components of the needle-free injection system (3.8) which are designated to harness, store, regulate, control and transfer to the dose chamber (3.2) and/or its contained medicinal product the energies required for the injection to occur, including means to prevent release of such energies, such as a"safety latch"

Note 1 to entry: This term is not used to refer to separate accessories which transfer energy into the needle-free injection system but which are separated from the needle-free injection systems at the time of the injection (such as a separate spring-cocking mechanism, a gas pressurizing tank, a foot pump or other separate device using electricity, muscle power or other energy source).

3.5

intended dose

amount of medicinal product meant to be expelled at one time

3.6

maximum dose

largest amount, which the manufacturer designates the needle-free injection system (3.8) is capable of expelling by one injection

3.7

minimum dose

smallest amount, which the manufacturer designates the needle-free injection system (3.8) is capable of expelling by one injection

3.8

needle-free injection system

NFIS

injector and its components and accessories that administer a medicinal product to a patient by using mechanical motion (such as movement of a piston or flow of a gas, but not to exclude other means) to impart kinetic energy to the medicinal product, without any part of the system penetrating the skin or mucous membranes

3.9

nozzle

component of an injector through which the medicinal product is expelled

Note 1 to entry: The nozzle can or cannot, depending on the device design, make physical contact with the skin or other membranes of the patient.

3.10

orifice

hole at the end of the nozzle (3.9) through which the medicinal product is expelled

3.11

performance profile

manufacturer-specified set of measurable and quantitative values and tolerance intervals which describes the proper functioning of a needle-free injection system (3.8) , in order to correctly deliver the medicinal product

3.12

reservoir

intermediate enclosure that holds and has contact with the medicinal product immediately prior to its transfer into the dose chamber (3.2)

Note 1 to entry: This container is often the vial or other enclosure filled with the medicinal product by the pharmaceutical manufacturer (and called the “primary packaging” in that industry). It can be single-dose or multi-dose, and usually requires some manipulation by the user, by an accessory filling device, or by the injector device itself to transfer the contents into the dose chamber (3.2) . There may be no medicinal reservoir for those needle-free injection systems (3.8) in which the dose chamber (3.2) is pre-filled by the manufacturer of the medicinal product.

3.13

unit container

packaging in which an individual component or needle-free injection system (3.8) is provided to a user