ISO 3826-4:2015 人間の血液および血液成分用のプラスチック製折りたたみ式容器—パート4：統合機能を備えた語頭音消失血液バッグシステム | ページ 6

3.1

aphaeresis (apheresis)

process by which blood being removed from a subject is immediately separated into component parts, usually to allow a desired component or components to be retained while the remainder is returned to the subject

3.2

aphaeresis set

whole aphaeresis blood bag system with integrated features

Note 1 to entry: Can also be called an aphaeresis kit or harness.

3.3

centrifugation

process in which circular motion is applied to a chamber about a central axis such that the fluid contents of the chamber are separated according to density where the most dense is towards the outer circumference of motion and the least dense is towards the inner circumference of motion

3.4

connector

component that allows one part of the set to be connected to another

3.5

citrate anticoagulant

citrate, in the form of sodium citrate or acid-citrate-dextrose, is added to the blood as it is drawn from the subject’s circulation and binds or chelates ionised calcium within the blood, thereby, impeding those steps of the coagulation pathway that are dependent on the presence of ionised calcium

3.6

clamp

device that prevents the flow of fluid through the lumen

Note 1 to entry: These can be locking (permanent) or non-locking (temporary).

3.7

extracorporeal circuit

path followed by whole blood or blood components when they are outside the subject’s circulation

3.8

fluid pathway

route along which fluids (whole blood, blood components, ancillary intravenous solutions) pass composed of tubing, chambers, connectors (3.4) and pressure sensors, and needles

Note 1 to entry: The fluid pathway is constructed to ensure that the fluid within it remains sterile and to ensure that there are no restrictions or obstructions within it that might result in cellular damage or activation of the coagulation cascade.

3.9

leucocyte filter

filter used to reduce the content of leucocytes in blood or blood components

3.10

pilot sample

sample of unmistakable identity to be used for testing

3.11

plasma

blood plasma is a liquid component of blood

Note 1 to entry: It makes up of about 55 % of total blood volume.

3.12

plastics container

bag of plastic material complete with collecting tube and needle, port(s), anticoagulant and/or preservative solutions, and transfer tube(s) and associated container(s) where applicable

3.13

platelets

platelets or thrombocytes are small, irregularly shaped, clear cells with no nucleus involved in haemostasis leading to the formation of blood clots

3.14

platelet additive solution

PAS

solution in which platelets (3.13) are suspended

3.15

red blood cell additive solution

RAS

solution added to packed red cells to increase the storage life of red blood cells and prevent haemolysis

3.16

platelet storage bag

PSB

bag suitable for appropriate storage of a therapeutic dose of platelet concentrates obtained from a single donation

3.17

red blood cell storage bag

bag suitable for storage of a therapeutic dose of red cells obtained from a single donation

3.18

pre-collection sampling device

device integrated in the collect line of blood collection systems or aphaeresis disposable sets designed to allow blood samples to be obtained at the beginning of a collection procedure without breaching the sterility of the collected components

Note 1 to entry: Usually incorporates a small reservoir from which the required blood samples are withdrawn. If a skin plug is obtained at the point of venepuncture, it is likely to be trapped in the reservoir rather than being drawn into the collected component(s), thereby, reducing the risk of bacterial contamination of the collected component(s).

Note 2 to entry: Also called PDS (pre-donation sampling device).

3.19

post-collection sampling device

device that can be integrated to allow a blood component sample to be taken, for example, for sterility testing or bacterial screening

3.20

needlestick protection device

NPD

device integrated in the donor line of blood bag systems containing the donor needle and designed to prevent undesirable needle sticks after use of the donor needle

Note 1 to entry: See ISO 23908.

3.21

replacement fluid

fluid used during an aphaeresis procedure to replace some or all of the blood volume associated with the collected components

3.22

anticoagulant safety connector

connector (3.4) specifically intended for use with citrate anticoagulant (3.5) to prevent accidental misconnection of anticoagulant with replacement fluid (3.21)

Note 1 to entry: An appropriate ISO standard is under preparation (ISO 18250-8).

3.23

shelf-life

period between the date of sterilization and the expiry date after which the sets should not be used

3.24

sterile barrier filter

filter intended to prevent micro-organisms or bacteria from entering a sterile fluid pathway (3.8)