ISO 3725

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.

Titre manque

General Information

• Status: Not Published
• ICS: 47.020.99 - Other standards related to shipbuilding and marine structures
• Technical Committee: ISO/TC 8 - Ships and marine technology
• Drafting Committee: ISO/TC 8/WG 12 - Aquatic nuisance species
• Current Stage: 6000 - International Standard under publication
• Completion Date: 15-May-2023

Standards Content (Sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 3725
ISO/TC 8 Secretariat: SAC
Voting begins on: Voting terminates on:
2022-08-18 2022-11-10
Ships and marine technology — Aquatic nuisance species
— Methods for evaluating the performance of compliance
monitoring devices for ballast water discharges
ICS: 47.020.99
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FOR COMMENT AND APPROVAL. IT IS
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ISO/DIS 3725:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 3725
ISO/TC 8 Secretariat: SAC
Voting begins on: Voting terminates on:
Ships and marine technology — Aquatic nuisance species
— Methods for evaluating the performance of compliance
monitoring devices for ballast water discharges
ICS: 47.020.99
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 3725:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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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

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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.
© ISO 2022 – All rights reserved
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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

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

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

...