ISO 3725:2023
(Main)Ships and marine technology — Aquatic nuisance species — Methods for evaluating the performance of compliance monitoring devices for ballast water discharges
Ships and marine technology — Aquatic nuisance species — Methods for evaluating the performance of compliance monitoring devices for ballast water discharges
This document specifies methods to evaluate the performance of a specific class of analytical instruments, known as compliance monitoring devices (CMDs). These instruments are designed and intended to examine ballast water to determine whether a sample meets or exceeds limits for the concentration of living or viable organisms. These limits include those specified by the International Maritime Organization (IMO) Regulation D-2 in the International Convention for the Control and Management of Ships' Ballast Water and Sediments[4] or other discharge standards (DS) adopted by national or regional authorities. The test methods measure the agreement between the CMD and a reference method to calculate trueness and precision. Both trueness and precision consider only simple, categorical outcomes (e.g. “meets” or “exceeds” the DS). The performance metric reliability is quantified by the frequency of instances when the CMD is not available or is not operating as expected. The set of tests and trials is based upon the CMD manufacturer claims, such as the DS group(s) targeted by the CMD, and known limitations, including those based upon the salinity of the sample water. NOTE Additional tests and trials, if required by the end-user, can follow this general test method. Guidance on determining experimental power is found in 7.5. This document provides guidance for customizing the tests to evaluate the claims of the manufacturer or to address optional factors of interest to the end-users. This document does not set or recommend success criteria of any performance metric, as these are appropriately defined by the end-users.
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INTERNATIONAL ISO
STANDARD 3725
First edition
2023-07
Ships and marine technology —
Aquatic nuisance species — Methods
for evaluating the performance of
compliance monitoring devices for
ballast water discharges
Reference number
ISO 3725:2023(E)
© ISO 2023
---------------------- Page: 1 ----------------------
ISO 3725:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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---------------------- Page: 2 ----------------------
ISO 3725:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 5
4.1 C ompliance with the discharge standard . 5
4.2 Reference method . 5
4.3 Challenge water . 6
4.4 Test concentrations of organisms. 6
5 E v a lu at ion me t r ic s .7
5.1 General . 7
5.1.1 Overview . 7
5.1.2 Measurement protocols . 7
5.1.3 Categorical outcomes . 7
5.2 Trueness . 8
5.2.1 Overview . 8
5.2.2 Measurement approach . 8
5.2.3 Statistical calculations . 9
5.3 Precision . . . 10
5.3.1 Overview . 10
5.3.2 Measurement approach . 11
5.4 Reliability . 11
6 E valuation test types .12
6.1 Overview .12
6.2 Laboratory tests with prepared challenge water .12
6.2.1 Challenge water .12
6.2.2 Cultured organisms .13
6.2.3 Sample volumes and organism concentrations .13
6.2.4 Sample handling and analysis . 13
6.3 Laboratory tests using natural water with ambient organisms . 14
6.3.1 Natural water . 14
6.3.2 Ambient organisms . 14
6.3.3 Sample volume . 14
6.3.4 Sample handling and analysis . 14
6.4 Field tests using treated water .15
6.4.1 Treated water .15
6.4.2 Organisms present post treatment . 15
6.4.3 Sample volume .15
6.4.4 Sample handling and analysis . 15
6.4.5 Test information and descriptions . 15
7 Experimental design .16
7.1 General . 16
7.2 CMD characteristics . 17
7.3 Known CMD limitations . 17
7.4 Basic evaluation requirements . 18
7.5 Experimental power and sample sizes . 23
7.6 Additional, optional factors for consideration . 24
7.7 Ancillary analyses . 24
8 Test quality management and reporting .25
Annex A (informative) Typically available cultures of organisms .26
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ISO 3725:2023(E)
Annex B (informative) Additional, optional factors for testing .27
Bibliography .28
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ISO 3725:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 8, Ships and marine technology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO 3725:2023(E)
Introduction
A compliance monitoring device (CMD) is an instrument intended to analyse samples of ballast water,
to estimate whether the concentration of living or viable organisms present in the sample exceeds,
or is at risk of exceeding, the regulated limit [i.e. the discharge standard, (DS)]. Typically, CMDs are
designed for use in shipboard and field locations to provide results rapidly and with less effort relative
to complex analyses. CMDs are instruments that are relatively new to their application in ballast
water testing. They can rely upon standard optical, chemical, or physical measurements, but these
technologies are deployed in unique configurations. They can be packaged in a rugged, transportable
housing, or installed as shipboard equipment. A CMD may operate along a spectrum of water types with
diverse assemblages of organisms. As intended, CMDs provide critical information to vessel inspectors,
ballast water management system (BWMS) commissioning test teams, Port State Control Officers, ship
owners, among others.
This document was developed in response to the need for a standardized approach to evaluate the
performance of CMDs. This evaluation includes:
— laboratory-based tests using prepared sample water amended with cultured organisms as well as
dissolved and particulate materials;
— laboratory-based tests using samples of natural assemblages of organisms, experimentally
manipulated to achieve target concentrations of living or viable organisms (but without manipulation
of dissolved and particulate materials);
NOTE 1 It is recognized that the end user can require laboratory testing with ambient organisms instead of,
or in addition to, cultured organisms. Additionally, the end user can require that both types of laboratory-based
tests are conducted using water that is treated by a BWMS or has undergone a simulated ballast water treatment,
instead of, or in addition to, un-treated water.
— field-based tests using samples of water treated with a BWMS collected aboard a ship.
This standardized approach defines a general test procedure and minimum set of trials to evaluate the
performance of a CMD. The key evaluation metrics are accuracy (hereafter, “trueness” - the agreement
to a reference method), precision, and reliability. While a CMD may report numerical values or estimates
of organism concentrations, trueness and precision are determined based upon the agreement between
the CMD and reference method on the sample disposition (i.e. whether the sample meets or exceeds the
DS).
NOTE 2 This approach is not appropriate to evaluate methods or devices intended to be used as an alternate to
the reference method, i.e. with precise, numerical measurements across a wide range of organism concentrations.
The test methods are adaptable, such that additional factors which are deemed important — e.g.
interferences, organism types, or water characteristics — may be addressed experimentally and
included in the set of performance metrics. This flexibility allows end-users to supplement these
minimal test requirements to examine additional characteristics, such as CMD performance under
different types of BWMS treatments.
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INTERNATIONAL STANDARD ISO 3725:2023(E)
Ships and marine technology — Aquatic nuisance species
— Methods for evaluating the performance of compliance
monitoring devices for ballast water discharges
1 Scope
This document specifies methods to evaluate the performance of a specific class of analytical
instruments, known as compliance monitoring devices (CMDs). These instruments are designed and
intended to examine ballast water to determine whether a sample meets or exceeds limits for the
concentration of living or viable organisms. These limits include those specified by the International
Maritime Organization (IMO) Regulation D-2 in the International Convention for the Control and
[4]
Management of Ships' Ballast Water and Sediments or other discharge standards (DS) adopted by
national or regional authorities.
The test methods measure the agreement between the CMD and a reference method to calculate
trueness and precision. Both trueness and precision consider only simple, categorical outcomes (e.g.
“meets” or “exceeds” the DS). The performance metric reliability is quantified by the frequency of
instances when the CMD is not available or is not operating as expected.
The set of tests and trials is based upon the CMD manufacturer claims, such as the DS group(s) targeted
by the CMD, and known limitations, including those based upon the salinity of the sample water.
NOTE Additional tests and trials, if required by the end-user, can follow this general test method. Guidance
on determining experimental power is found in 7.5. This document provides guidance for customizing the tests
to evaluate the claims of the manufacturer or to address optional factors of interest to the end-users.
This document does not set or recommend success criteria of any performance metric, as these are
appropriately defined by the end-users.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11711-1:2019, Ships and marine technology — Aquatic nuisance species — Part 1: Ballast water
discharge sample port
ISO 11711-2:2022, Ships and marine technology — Aquatic nuisance species — Part 2: Ballast water sample
collection and handling
ISO 21748, Guidance for the use of repeatability, reproducibility and trueness estimates in measurement
uncertainty evaluation
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ASTM D1141-98, Standard Practice for Preparation of Substitute Ocean Water
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
1
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ISO 3725:2023(E)
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
accuracy
closeness of agreement between a test result and the accepted reference value
Note 1 to entry: The more specific term, trueness (3.24), is used as a metric throughout this standard.
[SOURCE: ISO 5725-1:1994, 3.6, modified — Note 1 to entry has been replaced.]
3.2
agreement
concurrence between two independent measurements on the outcome of analysis
Note 1 to entry: Analysis outcomes are qualitative or categorical descriptions of whether a sample meets or
exceeds the discharge standard (3.13).
3.3
ambient water
natural water
water collected directly from the natural environment that 1) contains natural communities of
organisms, dissolved and particulate constituents, and 2) has intrinsic characteristics, such as
temperature and salinity
3.4
ballast water
water with its abiotic and biotic constituents taken on board a ship to control trim, list, stability or
stresses of the ship
3.5
ballast water management system
BWMS
equipment that processes ballast water (3.4) such that the water discharged (the treated water) is
intended to meet the specified performance requirements for eliminating, inactivating, or reducing
aquatic organisms
3.6
calibration
analysis, in water, of standards to develop a relationship between raw output of an analytical system
and analyte concentration
3.7
calibration standard
sample containing the analyte of interest at a known concentration either purchased from an external
source or prepared in-house from materials of known purity or concentration, or both, and used to
calibrate the measurement system
3.8
challenge water
water prepared or manipulated (e.g. by adding organisms and abiotic constituents) to achieve minimum
test criteria when testing the performance of equipment, in this case compliance monitoring devices
(3.11)
Note 1 to entry: This protocol shares some characteristics with the minimum water quality requirements
for challenge water for type approval testing (3.25) of the International Maritime Organization and USA, such
as salinity and temperature ranges and abiotic constituents. However, requirements for concentrations and
diversity of organisms are unique to this application.
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ISO 3725:2023(E)
3.9
colonial organisms
collection of multiple, clonal individuals that are physically connected
Note 1 to entry: Clusters of connected, but non-clonal individuals are typically referred to as aggregated
organisms.
3.10
compliance monitoring device
CMD
instrument and its associated analytical methodology typically used as a rapid assessment of the
concentration of living or viable organisms in treated ballast water for the purpose of determining
compliance or non-compliance with a discharge standard (3.13)
3.11
detection limit
method detection limit
lowermost quantity or concentration measurable by the compliance monitoring device (3.10)
Note 1 to entry: In the context of compliance monitoring device (CMD) evaluation, the detection limit is specified
by the manufacturer. The CMD evaluation may include test samples with concentrations reflecting the stated
detection limit to verify the manufacturer claim (3.16).
Note 2 to entry: In the context of reference method (3.21), the method detection limit is according to the definition
in ISO/IEC Guide 99:2007.
3.12
dissolved organic matter
DOM
mass of organic compounds present in water that are not separated by particle (≤0,7 µm) filtration
Note 1 to entry: Dissolved organic carbon is a related quantity that is commonly measured directly. Although the
two quantities are related, they are distinct and should be clearly identified.
3.13
discharge standard
DS
regulated limits of organism concentrations allowable in discharged ballast water
Note 1 to entry: Regulation D-2 of the International Maritime Organization’s Ballast Water Management
Convention.
Note 2 to entry: The term is generic unless a particular DS is specified.
Note 3 to entry: A DS is also known as a performance standard.
3.14
independent testing organization
testing organization that is free of any conflict of interest with the manufacturer of the compliance
monitoring device (3.10)
3.15
living organism
organism that demonstrates characteristics of life (movement, membrane integrity, etc.)
Note 1 to entry: It is possible that living organisms are not viable (3.27).
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ISO 3725:2023(E)
3.16
manufacturer claims
specific characteristics of the compliance monitoring device (3.10) that are asserted by the manufacturer
or vendor of the device
Note 1 to entry: Claims typically include the organisms size class(es) or indicator microbe(s) targeted by the
device, limitations based upon organism characteristics (such as autotrophy), water temperature and salinity
ranges, as well as the detection limits, accuracy, and precision of the compliance monitoring device.
3.17
mineral matter
MM
mass of inorganic compounds present in water and separated by particle (≤0,7 µm) filtration
Note 1 to entry: MM is estimated as the mass difference between total suspended solids (3.22) and particulate
organic matter (3.18).
3.18
particulate organic matter
POM
mass of organic matter present in water and separated by particle (≤0,7 µm) filtration
Note 1 to entry: Particulate organic carbon is a related quantity and composes a portion of the mass of POM.
Although the two quantities are related, they are distinct and should be clearly identified.
3.19
precision
agreement between replicate measurements of a sample measured under the same conditions
Note 1 to entry: The same conditions include the same sample, the same instrument unit, and the same analyst,
if applicable.
3.20
reagent-grade, purified water
water meeting the characteristics of Type I or II water, used as the basis for preparing challenge water
for laboratory testing
Note 1 to entry: The characteristics of Type I or II water are defined in ASTM D1193-06.
3.21
reference method
analytical method that produces a value used as a benchmark
Note 1 to entry: Reference methods produce direct measurements of numerical concentrations that are
comparable to the discharge standard (3.13).
Note 2 to entry: Reference methods are typically methods used in ballast water management system (3.5) type
approval testing (3.25).
3.22
total suspended solids
TSS
mass of organic and inorganic matter present in water and separated by particle (≤0,7 µm) filtration
Note 1 to entry: TSS is composed of mineral matter and particulate organic matter.
3.23
trial
complete set of samples and sample analyses associated with a single test condition, such as water
salinity
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ISO 3725:2023(E)
3.24
trueness
closeness of agreement between the average value obtained from a large series of test results and an
accepted reference value
[SOURCE: ISO 5725-1:1994, 3.7, modified — Notes 1 and 2 to entry have been deleted.]
3.25
type approval testing
testing performed as part of a formal certification of a ballast water management system (3.5) for use
aboard ships
3.26
uncertainty
measurement uncertainty
parameter, associated with the result of a measurement, which characterizes the dispersion of the
values that can reasonably be attributed to the measurand
[SOURCE: ISO 21748:2017, 3.14, modified — “measurement uncertainty” has been added as a preferred
term; Notes 1, 2 and 3 to entry have been deleted.]
3.27
viable
living and capable of reproduction
Note 1 to entry: Manufacturers shall indicate whether their compliance monitoring device (3.10) quantifies living
or viable organisms, and the test should be designed to evaluate their claims using the appropriate reference
method (3.21) for living or viable organisms.
4 General
4.1 C ompliance with the discharge standard
A compliance monitoring device (CMD) determines whether a sample is likely to comply with or exceed
[4]
the discharge standard (DS), such as the IMO Regulation D-2 which sets limits on the concentration of
viable organisms in the following size or taxonomic groups:
— organisms ≥50 µm in minimum dimension;
— organisms ≥10 µm and <50 µm in minimum dimension;
— toxicogenic Vibrio cholerae (serotypes O1 and O139);
— Escherichia coli;
— intestinal enterococci.
NOTE National or regional authorities can define the same or similar categories and concentration limits.
The test methods described in this document are generic: the methods apply to any of the groups
defined in the DS and the corresponding reference method used for each of those defined groups.
This performance evaluation considers the claims of a CMD manufacturer, such as those defining the
targeted group(s), the relevant DS e.g. References [4] and [5], and the stated limitations, such as limits
on the salinity of the sample water.
4.2 Reference method
A reference method is an analytical approach used to quantify living or viable organisms in one of the
categories of a DS (see 4.1). Typically, the reference method is used during type approval (TA) tests,
[6] [7]
such as those prescribed in the test protocols of the IMO or the United States. In general, a reference
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ISO 3725:2023(E)
method estimates numerical concentrations of living or viable organisms in a single category of DS.
Consequently, each category examined requires a unique set of measurements using the appropriate
reference method.
The numerical results from the reference me
...
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Voting begins on: Voting terminates on:
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Ships and marine technology — Aquatic nuisance species
— Methods for evaluating the performance of compliance
monitoring devices for ballast water discharges
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STANDARDS MAY ON OCCASION HAVE TO
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ISO/DIS 3725:2022(E)
DRAFT INTERNATIONAL STANDARD
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ISO/TC 8 Secretariat: SAC
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Ships and marine technology — Aquatic nuisance species
— Methods for evaluating the performance of compliance
monitoring devices for ballast water discharges
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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ISO/DIS 3725:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General . 5
4.1 Compliance with the discharge standard (DS) . 5
4.2 Reference method . 6
4.3 Challenge water . 6
4.4 Test concentrations of organisms. 6
5 Evaluation metrics .7
5.1 General . 7
5.1.1 Overview . 7
5.1.2 Measurement protocols . 7
5.1.3 Categorical outcomes . 7
5.2 Trueness . 8
5.2.1 Overview . 8
5.2.2 Measurement approach . 8
5.2.3 Statistical calculations . 9
5.3 Precision . . . 10
5.3.1 Overview . 10
5.3.2 Measurement approach . 11
5.4 Reliability . 11
6 Evaluation test types .12
6.1 Overview .12
6.2 Laboratory tests with prepared challenge water .12
6.2.1 Challenge water .12
6.2.2 Cultured organisms .13
6.2.3 Sample volumes and organism concentrations .13
6.2.4 Sample handling and analysis . 13
6.3 Laboratory tests using natural water with ambient organisms . 14
6.3.1 Natural water . 14
6.3.2 Ambient organisms . 14
6.3.3 Sample volume .15
6.3.4 Sample handling and analysis . 15
6.4 Field tests using treated water .15
6.4.1 Treated water .15
6.4.2 Organisms present post treatment . 15
6.4.3 Sample volume .15
6.4.4 Sample handling and analysis . 15
6.4.5 Test information and descriptions . 16
7 Experimental design .16
7.1 General . 16
7.2 General CMD characteristics . 17
7.3 Known CMD limitations . 18
7.4 Basic evaluation requirements . 19
7.5 Experimental power and sample sizes . 20
7.6 Additional, optional factors for consideration . 22
7.7 Ancillary analyses .22
8 Test quality management and reporting .22
Annex A (informative) Typically available cultures of organisms .23
iii
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ISO/DIS 3725:2022(E)
Annex B (informative) Additional, optional factors for testingList and description of
optional factors .24
Bibliography .26
iv
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ISO/DIS 3725:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 8, Ships and marine technology, WG12,
Aquatic nuisance species.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
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---------------------- Page: 5 ----------------------
ISO/DIS 3725:2022(E)
Introduction
A Compliance Monitoring Device (CMD) is an instrument intended to analyse samples of ballast water
to estimate whether the concentration of living or viable organisms present in the sample exceeds—
or is at risk of exceeding—the regulated limit (i.e. the discharge standard, [DS]). Typically, CMDs
are designed for use in shipboard and field locations to provide results rapidly and with less effort
relative to complex analyses. CMDs are instruments that are relatively new to their application in
ballast water testing. They may rely upon standard optical, chemical, or physical measurements, but
these technologies are deployed in unique configurations, perhaps packaged in a rugged, transportable
housing, or installed as shipboard equipment. A particular CMD may operate along a spectrum of water
types with diverse assemblages of organisms. As intended, CMDs provide critical information to vessel
inspectors, ballast water management system (BWMS) commissioning test teams, Port State Control
Officers, ship owners, and others.
This document was developed in response to the need for a standardized approach to evaluate the
performance of CMDs. The evaluation includes:
— Laboratory-based tests using prepared sample water amended with cultured organisms as well as
dissolved and particulate materials,
— Laboratory-based tests using samples of natural assemblages of organisms, experimentally
manipulated to achieve target concentrations of living or viable organisms (but without manipulation
of dissolved and particulate materials),
NOTE It is recognized that the end user may require laboratory testing with ambient organisms instead of
or in addition to cultured organisms. Additionally, the end user may require that both types of laboratory-based
tests are conducted using water that is treated by a BWMS or has undergone a simulated ballast water treatment,
instead or in addition to un-treated water.
— Field-based tests using samples of water treated with a BWMS collected aboard a ship.
This standardized approach defines a general test procedure and minimum set of trials to evaluate the
performance of a CMD. Key evaluation metrics are accuracy (hereafter, “trueness”: the agreement to a
reference method), precision, and reliability. While a CMD may report numerical values or estimates of
organism concentrations, trueness and precision are determined based upon the agreement between
the CMD and reference method on the sample disposition (i.e., whether the sample meets or exceeds the
DS).
NOTE This approach is not appropriate to evaluate methods or devices intended to be used as an alternate to
the reference method, i.e., with precise, numerical measurements across a wide range of organism concentrations.
Test requirements consider the manufacturer claims for the CMD, which may include one or more
of size classes of organisms or indicator microbes defined in the IMO Ballast Water Management
[1]
Convention or another DS adopted by national or regional authorities. Test requirements also
consider the limitations of the CMD: if the CMD only operates in a limited range of water salinities,
only those salinities are included in the test. The test method is adaptable, such that additional factors
deemed important—e.g., interferences, organism types, or water characteristics—may be addressed
experimentally and included in the set of performance metrics. This flexibility allows end-users to
supplement these minimal test requirements to examine additional characteristics, such as CMD
performance under different types of BWMS treatments.
This document does not specify requirements or acceptable values for any performance metric, as
these shall be defined by the end users. While this standard does not specify acceptance criteria, it
does provide guidance to estimate the replication needed, given defined set thresholds for performance
metrics.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 3725:2022(E)
Ships and marine technology — Aquatic nuisance species
— Methods for evaluating the performance of compliance
monitoring devices for ballast water discharges
1 Scope
This document specifies methods to evaluate the performance of a specific class of analytical
instruments—known as Compliance Monitoring Devices (CMDs). CMDs are designed and intended to
examine ballast water to determine whether a sample meets or exceeds limits for the concentration of
living or viable organisms, such as those limits specified by the International Maritime Organization
[1]
(IMO) D-2 Discharge Standard (DS) or another DS adopted by national or regional authorities. For
the performance metrics trueness and precision, test methods evaluate the agreement between the
CMD and a reference method. Both trueness and precision consider only simple, categorical outcomes
(e.g., “meets” or “exceeds” the DS). The performance metric reliability is quantified by the frequency of
instances when the CMD is not available or is not operating as expected.
The set of tests and trials is based upon the CMD manufacturer claims—such as the DS group(s) targeted
by the CMD—and known limitations, including those based upon the salinity of the sample water.
NOTE Additional tests and trials, if required by the end-user, may follow this general test method. Guidance
on determining experimental power is in the body of this text (7.5), and additional, optional factors for
consideration are included as an informative Annex.
The standard does not set or recommend success criteria of any performance metric, as these are
appropriately defined by the end-users. This document provides guidance for customizing the tests and
trials necessary to evaluate the claims of the manufacturer or to address particular factors of interest
to the end-users.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ASTM D1129-13Standard Terminology Relating to Water
ASTM D1141- 98(2013)Standard Practice for the Preparation of Substitute Ocean Water
ASTM D1193 - 06(2018)Standard Specification for Reagent Water
BWM 2/Circ.42/Rev. 2 (2020) Guidance on ballast water sampling and analysis for trial use in accordance
with the BWM convention and guidelines
BWM 2/Circ.70/Rev. 2 (2020) Guidance for the commissioning testing of ballast water management
systems
ISO/IEC 99:2007, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO 5725, Accuracy (trueness and precision) of measurement methods and results
ISO 21748, Guidance for the use of repeatability, reproducibility and trueness estimates in measurement
uncertainty evaluation
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ISO/DIS 3725:2022(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
accuracy
the closeness of agreement between a test result and the accepted reference value
Note 1 to entry: the more specific term, trueness (3.25), is used as a metric throughout this standard.
[SOURCE: ISO 5725-1]
3.2
agreement
two or more independent measurements in accord on the outcome of analysis
Note 1 to entry: Analysis outcomes are qualitative or categorical descriptions whether a sample meets or exceeds
the discharge standard (3.13).
3.3
ambient water
natural water
waters collected directly from the natural environment that 1) contain natural communities of
organisms, dissolved and particulate constituents, and 2) have intrinsic characteristics, such as
temperature and salinity
3.4
ballast water
water with its abiotic and biotic constituents taken on board a ship to control trim, list, stability or
stresses of the ship
3.5
ballast water management system
BWMS
equipment that processes ballast water (3.4) such that the water discharged (the treated water) is
intended to meet the specified performance requirements for eliminating, inactivating, or reducing
aquatic organisms
3.6
calibration
in the analysis of water, the analysis of standards to develop a relationship between raw output of an
analytical system and analyte concentration
3.7
calibration standard
sample containing the analyte of interest at a known concentration either purchased from an external
source or prepared in-house from materials of known purity or concentration, or both, and used to
calibrate the measurement system
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ISO/DIS 3725:2022(E)
3.8
challenge water
water prepared or manipulated (e.g. by adding organisms and abiotic constituents) to achieve minimum
test criteria when testing the performance of equipment, in this case CMDs
Note 1 to entry: This protocol shares some characteristics with the IMO and US minimum water quality
requirements for challenge water for type approval testing (3.26), such as salinity and temperature ranges and
abiotic constituents. However, requirements for concentrations and diversity of organisms are unique to this
application.
3.9
colonial organisms
collection of multiple, clonal individuals that are physically connected
Note 1 to entry: Clusters of connected, but non-clonal individuals are typically referred to as aggregated
organisms.
3.10
compliance monitoring device
CMD
an instrument and its associated analytical methodology typically used as a rapid assessment of the
concentration of viable organisms in treated ballast water for the purpose of determining compliance
[1]
or non-compliance with a DS, e.g., IMO D-2 discharge standard
3.11
detection limit
method detection limit
lowermost quantity or concentration measurable by the CMD (3.10)
Note 1 to entry: In the context of CMD evaluation, the detection limit is specified by the manufacturer. The
CMD evaluation may include test samples with concentrations reflecting the stated detection limit to verify the
manufacturer claim (3.16).
Note 2 to entry: For the reference method (3.22), the method detection limit is in accord with the definition in
ISO/IEC 99:2007.
3.12
dissolved organic matter
DOM
mass of organic compounds present in water that are not separated by particle (≤0,7 µm) filtration
Note 1 to entry: Dissolved organic carbon is a related quantity that is commonly measured directly; though the
two quantities are related, they are distinct and should be clearly identified.
3.13
discharge standard
DS
regulated limits of organism concentrations allowable in discharged ballast water, such as those
specified in Regulation D-2 of the International Maritime Organization’s Ballast Water Management
[1]
Convention
Note 1 to entry: The term is generic unless a particular DS is specified.
Note 2 to entry: Also known as the “performance standard” (3.19).
3.14
independent testing organization
a testing organization that is free of any conflict of interest with the manufacturer of the CMD (3.10)
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ISO/DIS 3725:2022(E)
3.15
living
organisms that demonstrate characteristics of life (movement, membrane integrity, etc.)
Note 1 to entry: living organisms may or may not be viable (3.28).
3.16
manufacturer claims
specific characteristics of the CMD that are asserted by the manufacturer or vendor of the device
Note 1 to entry: Claims typically include the organisms size class(es) or indicator microbe(s) targeted by the
device, limitations based upon organism characteristics (such as autotrophy), water temperature and salinity
ranges, as well as the detection limits, accuracy, and precision of the CMD.
3.17
mineral matter
MM
mass of inorganic compounds present in water and separated by particle (≤0,7 µm) filtration
Note 1 to entry: MM is estimated as the mass difference between total suspended solids (3.23) and particulate
organic matter (3.18).
3.18
particulate organic matter
POM
mass of organic matter present in water and separated by particle (≤0,7 µm) filtration
Note 1 to entry: Particulate organic carbon is a related quantity and composes a portion of the mass of POM;
though the two quantities are related, they are distinct and should be clearly identified.
3.19
performance standard
regulated limits of organism concentrations allowable in discharged ballast water, such as those
specified in Regulation D-2 of the International Maritime Organization’s Ballast Water Management
[1]
Convention
Note 1 to entry: Also known as the “discharge standard” (3.13).
3.20
precision
agreement between replicate measurements of a sample measured under the same conditions
Note 1 to entry: The same conditions include the same sample, the same instrument unit, and the same analyst,
if applicable.
3.21
reagent-grade, purified water
water meeting characteristics of Type I or II water, as defined in ASTM 1193-06(2018) used as the basis
for preparing challenge water for laboratory testing
3.22
reference method
analytical method that produces a value used as a benchmark
Note 1 to entry: Reference methods produce direct measurements of numerical concentrations that are
comparable to the discharge standard (3.13).
Note 2 to entry: Reference methods are typically methods used in BWMS type approval testing (3.26).
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ISO/DIS 3725:2022(E)
3.23
total suspended solids
TSS
mass of organic and inorganic matter present in water and separated by particle (≤0,7 µm) filtration
Note 1 to entry: TSS is composed of mineral matter and particulate organic matter.
3.24
trial
a complete set of samples and sample analyses associated with a single test condition, s
...
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