ISO 21710:2020 バイオテクノロジー—微生物資源センターでのデータ管理と公開に関する仕様 | ページ 6

3.1

accessioning

documenting the addition of a new microbial material (3.17) and/or associated data to an MRC (3.18)

[SOURCE: ISO 20387:2018, 3.1, modified — Replaced “biological” by “microbial”; “a biobank” was replaced by “an MRC”.]

3.2

acquisition

act of obtaining possession and/or custody of microbial material (3.17) and/or associated data

[SOURCE: ISO 20387:2018, 3.2, modified — Replaced “biological” by “microbial”.]

3.3

associated data

any information affiliated with microbial material (3.17) including but not limited to collection, taxonomic, deposit history and provider data

[SOURCE: ISO 20387:2018, 3.3, modified — Replaced “biological” by “microbial”, the coverage in the inclusion was modified to data management related categories.]

3.4

authentication

process by which microbial material (3.17) is characterized to a defined level of specification using appropriate technology/documentation to establish a conclusive basis for accepting the material as genuine

[SOURCE: ISO 20387:2018, 3.4, modified — Replaced “biological” by “microbial”.]

3.5

catalogue

systematically arranged list or record often including descriptive information

[SOURCE: ISO 20387:2018, 3.10]

Note 1 to entry: It can include printed and online catalogues.

3.6

deposit

act of transferring possession and/or custody of microbial material (3.17) and/or associated data from depositor (3.7) to MRC (3.18)

3.7

depositor

provider

person or entity from whom/which the microbial materials (3.17) and/or associated data is received or acquired

[SOURCE: ISO 20387:2018, 3.41, modified — Replaced “biological” by “microbial” and deleted “for biobanking” at the end.]

3.8

distribution

process of providing selected microbial material (3.17) and/or associated data to recipient(s) (3.24)

[SOURCE: ISO 20387:2018, 3.20, modified — Replaced “biological” by “microbial”; “/user(s)” was deleted.]

3.9

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]

3.10

IRCC

international recognized certificate of compliance

permit or equivalent document issued at the time of access as the evidence that the microbial material (3.17) and associated data has been accessed in accordance with the decision to grant PIC (3.22) , and that MTAs (3.19) have been established for the user and the utilization

Note 1 to entry: When available on the ABS Clearing-House of the Nagoya Protocol, an IRCC number can be attributed, which can be used as a reference number.

Note 2 to entry: This term is based on the Nagoya Protocol.

3.11

legacy microbial material and associated data

microbial material (3.17) and associated data acquired or received by the MRC (3.18) before the MRC has implemented this document

3.12

life cycle of data

all stages in the process of data usage from initial establishment to its discontinuation

3.13

MAA

material accession agreement

material acquisition agreement

contractual document between a depositor (3.7) and an MRC (3.18) in a material transfer process

Note 1 to entry: It documents basic data such as place and date of sampling in a standardized form, and specifies the role, rights, and duties of the depositor and MRC.

Note 2 to entry: MAA is synonymous to material deposit agreement (MDA). It is normally put in place by an MRC.

3.14

MAT

mutually agreed terms

contractual arrangements between a provider (3.7) of microbial material (3.17) and/or associated data, and a recipient (3.24)

Note 1 to entry: It sets out specific conditions for the fair and equitable sharing of benefits arising from the utilization of microbial materials and/or associated data, and that can also include further conditions and terms for such utilization as well as subsequent applications and commercialization.

3.15

MDS

minimum dataset

collection of technical and scientific data digitized in specific fields of a database, which is necessary to distinguish unambiguously a particular microbial material (3.17) and provides a minimum amount of information available for each accession in an MRC (3.18)

Note 1 to entry: Microbial materials, except for legacy microbial materials, cannot be inserted into the catalogue, if this information is not available.

3.16

metadata

data that defines and describes other data

[SOURCE: ISO/IEC 11179-1:2015, 3.2.16]

3.17

microbial material

any substance(s) derived or part obtained from a microorganism, and any complexes or association between microorganisms

Note 1 to entry: It comprises all prokaryotes (archaea and bacteria), some eukaryotic organisms (fungi, yeasts, algae, protozoa), any association between the latter (e.g. lichens), non-cellular entities (e.g. viruses), their replicable parts and other derived materials (e.g. genomes, plasmids, cDNA). It also includes some viable but not yet culturable microorganisms.

3.18

MRC

microbial resource centre

microbial biobank

microbial BRC

legal entity or part of a legal entity that performs biobanking of microbial material (3.17) and associated data

3.19

MTA

material transfer agreement

contractual documents between an MRC (3.18) and a recipient (3.24) in a material transfer process

Note 1 to entry: All the documents can be designated as MTA as long as they contain information about the in situ origin or the source of the microbial material and associated data, information about the provider and recipient, and information that defines the limits of the use of the microbial material and associated data

Note 2 to entry: An MTA can also be associated with a microbial material being deposited to meet the need of its depositor country/country of origin, particularly those that are the parties of the Convention of Biological Diversity (CBD) and Nagoya Protocol (NP).

3.20

patent deposit

service of MRCs for long-term preservation of microbial materials (3.17) for the purposes of patent procedure

Note 1 to entry: It is a special service of an MRC recognized as the International Depositary Authority (IDA) by the World Intellectual Property Organization (WIPO) for the purposes of patent procedures under the Budapest Treaty.

3.21

persistent identifier

unique identifier (3.27) that ensures permanent access for a digital object by providing access to it independently of its physical location or current ownership

Note 1 to entry: It is used in the context of digital objects that are accessible over the Internet. Typically, such an identifier is not only persistent but also actionable (e.g. URI).

[SOURCE: ISO 24619:2011, 3.2.4, modified — note 1 to entry was entirely replaced to describe the usage of this term.]

3.22

PIC

prior informed consent

permission of the country of origin to a user to access microbial materials (3.17) and/or associated traditional knowledge

Note 1 to entry: This term is based on the Nagoya Protocol.

3.23

preservation

act or activity to prevent or retard microbial or physical deterioration of microbial material (3.17)

[SOURCE: ISO 20387:2018, 3.34, modified — Replaced “biological” by “microbial”.]

3.24

recipient

user

person or entity to whom/which the microbial material (3.17) and/or associated data is distributed

[SOURCE: ISO 20387:2018, 3.44, modified — Replaced “biological” by “microbial”.]

3.25

safe deposit

service of MRCs for long-term preservation of microbial materials (3.17) with distribution restrictions at the discretion of the depositor (3.7)

Note 1 to entry: All information concerning the deposit (3.6) and the nature of the microbial materials are treated in the strictest confidence. Access to this type of microbial material is permitted only by documented request of the depositor.

3.26

storage

maintenance of microbial material (3.17) under specified conditions for future use

[SOURCE: ISO 20387:2018, 3.47, modified — Replaced “biological” by “microbial”.]

3.27

unique identifier

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

Note 1 to entry: Such an identifier can establish an unambiguous relationship between each microbial material and its associated data.

[SOURCE: ISO 20387:2018, 3.50]

Note 2 to entry: It can include accession number and other local identifiers (local IDs) in the web-based context.

3.28

URI

Uniform Resource Identifier

compact sequence of characters that uniquely identify an abstract or physical resource

Note 1 to entry: URI is a kind of unique identifier (3.17) . It is used in the field of computer science.

[SOURCE: IETF RFC 3986^[14]]