ISO 20387:2018 バイオテクノロジー—バイオバンキング—バイオバンキングの一般要件 | ページ 6

3.1

accessioning

logging

documenting the addition of a new biological material and/or associated data to a biobank

3.2

acquisition

act of obtaining possession and/or custody of biological material and/or associated data

3.3

associated data

any information affiliated with biological material including but not limited to research, phenotypic, clinical, epidemiologic, and procedural data

3.4

authentication

process by which biological material is characterized to a defined level of specification using appropriate technology/documentation to establish a conclusive basis for accepting the material as genuine

3.5

biobank

legal entity or part of a legal entity that performs biobanking (3.6)

3.6

biobanking

process of acquisitioning (3.2) and storing, together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data

3.7

biological material

any substance derived or part obtained from an organic entity such as a human, animal, plant, microorganism(s) or multicellular organism(s) that is(are) neither animal nor plant (e.g. brown seaweed, fungi)

3.8

biosafety

containment principles, technologies and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release

[SOURCE:Laboratory Biosafety Manual, third edition, WHO, 2004]

3.9

biosecurity

institutional and personal security measures and procedures designed to prevent the loss, theft, misuse, diversion or intentional/unintentional release of pathogens, genetically modified organisms, toxin-producing organisms, or parts thereof, as well as such toxins that are held, transferred and/or supplied by the biobank

3.10

catalogue

systematically arranged list or record often including descriptive information

3.11

cataloguing

act of creating and maintaining a systematically arranged list or record often including descriptive information

3.12

chain of custody

responsibility for or control of materials and associated data as they move through each step of a process

3.13

competence

ability to apply knowledge, experience, and skills to achieve intended results

[SOURCE:ISO 17100:2015, 2.4.9]

3.14

complaint

expression of dissatisfaction other than appeal by any person or organization to a biobank (3.5) , relating to the activities, products or results of that biobank where a response is expected

Note 1 to entry: The wording “activities, products or results” includes biological material and/or associated data.

Note 2 to entry: “Appeal” is defined in ISO/IEC 17000:2004, 6.4.

[SOURCE:ISO/IEC 17000:2004, 6.5 modified — “conformity assessment body or accreditation body” has been replaced by “biobank”, the words “products or results” have been added, Note 1 to entry and Note 2 to entry have been added]

3.15

conformity

fulfillment of a requirement

Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word “compliance” is synonymous but deprecated.

Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Note 1 to entry.

[SOURCE:ISO 9000:2015, 3.6.11]

3.16

critical

having a potential impact on the fitness for the intended purpose of biological material and/or associated data

3.17

dedicated area

space containing the biological material kept by the biobank (3.5) or where the biobank activities take place

3.18

destruction

process of eliminating biological material and/or deleting associated data, beyond any possible reconstruction

3.19

disposal

act of removing a biological material and/or associated data usually for scrapping, destruction or returning to provider/donor

3.20

distribution

process of providing selected biological material and/or associated data to recipient(s)/user(s)

3.21

documented information

information required to be controlled and maintained by an organization and the medium on which it is contained

Note 1 to entry: Documented information can be in any format and media and from any source.

[SOURCE:ISO 9000:2015, 3.8.6]

3.22

donor

organic entity such as a human, animal, plant etc. from which the biological material and/or associated data is collected for biobanking (3.6)

Note 1 to entry: A human donor can also be a provider (3.41) .

3.23

examination

set of operations having the objective of determining the value or characteristics of a property

[SOURCE:ISO 15189:2012, 3.7, modified — Notes to entry have been deleted]

3.24

fit for purpose

fitness for the intended purpose

in line with prearranged requirements for an intended use

Note 1 to entry: The definition of such requirements can take place within the biobank itself and/or in collaboration with users and should consider analytical and other relevant criteria.

3.25

governance

leadership that sets policy and management of operations and can advise/decide on scientific, administrative, technical, financial and other issues

3.26

impartiality

presence of objectivity

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence the activities of the biobank.

Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”, “freedom from conflicts of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.

[SOURCE:ISO/IEC 17021-1:2015, 3.2, modified — In Note 1 to entry “certification body” has been replaced by “biobank”]

3.27

interlaboratory comparison

organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions

[SOURCE:ISO/IEC 17043:2010, 3.4]

3.28

interoperability

capability to communicate, execute programs, or transfer data among various functional units in a manner that requires the user to have little or no knowledge of the unique characteristics of those units

[SOURCE:ISO/IEC 20944-1:2013, 3.6.1.24]

3.29

life cycle

consecutive and interlinked processes applied to biological material and associated data from collection, if applicable, acquisition or reception to distribution, disposal or destruction

Note 1 to entry: This term refers to the biobanking life cycle only.

3.30

metrological traceability

property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty

[SOURCE:ISO/IEC 17043:2010, 3.15]

3.31

microorganism

entity of microscopic size

Note 1 to entry: Microorganisms include viruses, all prokaryotes (archaea and bacteria), several eukaryotic organisms (fungi including yeasts, algae, protists).

3.32

nonconforming

deviating from a particular requirement

3.33

personnel

person(s) employed by or working for the biobank (3.5)

3.34

preservation

act to prevent or retard biological or physical deterioration of biological material

3.35

procedure

specified way to carry out an activity or a process

3.36

processing

performing any activity on biological material and associated data during all stages of the life cycle (3.29)

3.37

preparation

activities, taking place in a laboratory after acquisitioning, to make biological material ready for further use in the life cycle (3.29) , storage (3.47) or distribution (3.20)

Note 1 to entry: These activities can include, e.g. centrifuging, homogenizing, purifying, fixing, stabilizing, replicating, filtering, sorting, culturing, vacuum drying, freeze drying, freezing and thawing, tissue sectioning, fractionating, dispensing/aliquoting, cryopreserving.

3.38

processing method

procedure, applied to biological material and/or associated data during processing (3.36) , with potential to impact the intrinsic properties of the biological material and/or associated data produced as output

3.39

process

set of interrelated or interacting activities that use inputs to deliver an intended result

3.40

proficiency testing

evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons

Note 2 to entry: Some providers of proficiency testing in the medical area use the term “External Quality Assessment (EQA)” for their proficiency testing schemes, or for their broader programs, or both.

[SOURCE:ISO/IEC 17043:2010, 3.7, modified — In Note 2 to entry, reference to Annex A and the last sentence have been deleted]

3.41

provider

depositor

person or entity from whom/which the biological material and/or associated data is received or acquired for biobanking (3.6)

Note 1 to entry: Proficiency testing provider and external provider are not included.

3.42

pseudonymization

processing of individual data in such a manner that these data can no longer be attributed to a specific data subject without the use of additional information

Note 1 to entry: Additional information is kept separately and is subject to technical and organizational measures to ensure that the individual data are not attributed to an identified or identifiable subject.

3.43

rare biological material

biological material that is made precious by its scarcity

3.44

recipient

person or entity to whom/which the biological material and/or associated data is distributed

3.45

sample

portion of a whole

3.46

stability

ability of a biological material, when stored under specified conditions, to maintain a specified property value within specified limits for a specified period of time

[SOURCE:ISO Guide 30:2015, 2.1.15, modified — The words “reference material” have been replaced by “biological material” and Note 1 to entry has been deleted]

3.47

storage

maintenance of biological material under specified conditions for future use

3.48

tagging

labelling of a biological material for the purpose of identification, location or to give other information

Note 1 to entry: An electronic device can be used for this purpose.

3.49

traceability

ability to trace the history, application or location of an object

Note 2 to entry: In the field of metrology, the definition in ISO/IEC Guide 99 is the accepted definition.

[SOURCE:ISO 9000:2015, 3.6.13]

3.50

unique identifier

code that is associated with a single entity within a given system

Note 1 to entry: Such identifier establishes an unambiguous relationship between each biological material and its associated data.

3.51

user

customer, investigator, or other who/that receives or utilizes biobank service(s)

3.52

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]

3.53

verification

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.

Note 3 to entry: The word “verified” is used to designate the corresponding status.

[SOURCE:ISO 9000:2015, 3.8.12]

3.54

workflow

structured set of processes