ISO/TS 21560:2020 組織工学医療製品の一般的な要件 | ページ 6

3.1

active substance

substance comprised of manipulated cells, engineered tissues and/or other materials in the finished TEMP which has biological activity for its intended use

3.2

allogenic

cells, tissues, and organs in which the donor and recipient are genetically separate individuals of the same species

[SOURCE:ASTM F2312-11:2020, Clause 4, modified — alternative terms have been removed.]

3.3

autologous

cells, tissues, and organs in which the donor and recipient is the same individual

[SOURCE:ASTM F2312-11:2020, Clause 4, modified — alternative terms have been removed.]

3.4

bioactive agent

agent (e.g. peptide or protein) produced by (and purified from) naturally occurring or recombinant organisms, tissues or cell lines or synthetic analogs of such molecules

3.5

cellular therapeutic product

administration of cells to repair, modify or regenerate the recipient’s cells, tissues, and organs or their structure and function, or both

[SOURCE:ASTM F2312-11:2010, Clause 4, modified — term has been modified from"cell therapy".]

3.5.1

cell line

progeny of a primary culture after the first subculture

Note 1 to entry: A cell line may be finite or continuous.

3.6

excipient

material that is present in the TEMP (3.18) administered to a patient, other than the active substance(s)

3.7

finished TEMP

final formulated TEMP in its immediate container closure

3.8

genetically modified

having an altered or modified genetic material

[SOURCE:ASTM F2312-11:2020, Clause 4]

3.9

lifespan

period during which something exists

[SOURCE:ISO 19108:2002, 4.1.21]

3.10

medical device

[SOURCE:ISO/IEC Guide 63:2019, 3.7]

3.11

medical product

medicinal product (drug), biological product, medical device or a combination of these

[SOURCE:ISO 13022:2012, 3.4]

3.12

ancillary material

am

material that comes into contact with the TEMP during manufacturing, but is not intended to be part of the final product formulation

Note 1 to entry: AMs exclude non-biological consumables (e.g. tissue culture flasks, bags, tubing, pipettes, needles) and other plasticware that comes into contact with the TEMP or its components, but include consumables which have a biological component (e.g. coated dishes or beads).

Note 2 to entry: AMs exclude cells (e.g. feeder cells).

Note 3 to entry: In some cases, AM is described as raw material.

[SOURCE:ISO/TS 20399-1:2018, 3.1]

3.13

regenerative medicine

process of repairing, replacing, or regenerating human cells, tissues or organs to restore or establish normal function

[SOURCE:PAS 84:2012, 2.266]

3.14

scaffold

support or structural component or delivery vehicle, or matrix, consisting of synthetic and/or naturally-derived material(s), for modulating the biological properties (including, but not limited to, adhesion, migration, proliferation, differentiation) or transport of administered and/or endogenous cells and/or binding/transport of bioactive agents

[SOURCE:ASTM F2312-11:2020, Clause 4]

3.15

starting material

cells, tissues and/or additional substances, e.g. scaffolds, biomaterials, bioactive agents, which constitute the intended integral components of a TEMP

3.16

tissue

aggregation of specialized cells united in the performance of one or more particular function(s)

[SOURCE:ASTM F2312-11:2020, Clause 4]

3.17

tissue engineering

discipline that combines the principles of engineering and biology to obtain biological substitutes intended to regenerate, replace, modify, repair, or restore the function of tissues and organs

3.18

tissue-engineered medical product

TEMP

medical product consisting of manipulated cells and/or engineered tissues, with or without a synthetic and/or naturally-derived scaffold, that repairs, modifies, replaces, restores, or regenerates the recipient’s cells, tissues, or organs or their structure and function, or both

[SOURCE:ASTM F2312-11:2020, Clause 4]

3.19

xenogenic

cells, tissues, and organs in which the donor and recipient belong to different species

[SOURCE:ASTM F2312-11:2020, modified — alternative terms have been removed.]

3.20

validation

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated.

[SOURCE:ISO 9000:2015, 3.8.13]