ISO/PRF 17190-2

Urine-absorbing aids for incontinence -- Polyacrylate superabsorbent powders

Aides pour absorption d'urine -- Méthodes d'essai pour caractériser les matériaux absorbants à base de polymères

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 17190-2
ISO/TC 173/SC 3 Secretariat: SIS
Voting begins on: Voting terminates on:
2019-08-15 2019-11-07
Urine-absorbing aids for incontinence — Polyacrylate
superabsorbent powders —
Part 2:
Test method for determination of the amount of residual
acrylate monomers

Aides pour absorption d'urine — Méthodes d'essai pour caractériser les matériaux absorbants à base de

polymères —
Partie 2: Détermination de la quantité de monomères résiduels
ICS: 11.180.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 17190-2:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
---------------------- Page: 1 ----------------------
ISO/DIS 17190-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 17190-2:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principle ........................................................................................................................................................................................................................ 2

5 Reagents and Materials ................................................................................................................................................................................. 2

5.1 Water ............................................................................................................................................................................................................... 2

5.2 Sodium chloride solution ............................................................................................................................................................... 2

5.3 Phosphoric acid ...................................................................................................................................................................................... 2

5.4 Phosphoric acid solution ................................................................................................................................................................ 2

5.5 Acetonitrile ................................................................................................................................................................................................. 2

5.6 Acrylic acid ................................................................................................................................................................................................. 2

6 Apparatus ..................................................................................................................................................................................................................... 2

7 Calibration .................................................................................................................................................................................................................. 4

8 Conditioning .............................................................................................................................................................................................................. 4

9 Sampling ........................................................................................................................................................................................................................ 4

10 Procedure..................................................................................................................................................................................................................... 5

11 Calculation .................................................................................................................................................................................................................. 6

11.1 Calibration curve ................................................................................................................................................................................... 6

11.2 Amount of residual monomers ................................................................................................................................................. 6

12 Report .............................................................................................................................................................................................................................. 6

13 Precision ....................................................................................................................................................................................................................... 7

Annex A (informative) Notes on chromatographical testing ....................................................................................................... 8

Annex B (informative) Modification Track Sheet .................................................................................................................................10

Bibliography .............................................................................................................................................................................................................................11

© ISO 2019 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/DIS 17190-2:2019(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 [or Project Committee] ISO/TC [or ISO/PC] ###,

[name of committee], Subcommittee SC ##, [name of subcommittee].

This second/third/… edition cancels and replaces the first/second/… edition (ISO #####:####), which

has been technically revised.
The main changes compared to the previous edition are as follows:
— xxx xxxxxxx xxx xxxx
A list of all parts in the ISO ##### series can be found on the ISO website.

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.
iv © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 17190-2:2019(E)
Urine-absorbing aids for incontinence — Polyacrylate
superabsorbent powders —
Part 2:
Test method for determination of the amount of residual
acrylate monomers
1 Scope

This test method determines the sum of residual monomeric sodium acrylate and acrylic acid present

in polyacrylate (PA) superabsorbent powders as acrylic acid.

NOTE This standard does not claim to address all of the safety concerns, if any, associated with its use. It is

the responsibility of the user of this standard to establish appropriate safety and health practices and determine

the applicability of regulatory limitations prior to use. It is expected that the person performing this test has

been fully trained in all aspects of this procedure.
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 187, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for

monitoring the atmosphere and conditioning of samples
ISO 3696, Water for analytical laboratory use — Specification and test methods
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 http: //www .electropedia .org/
3.1
amount of residual monomers
sum of residual monomeric sodium acrylate and acrylic acid
3.2
sample

product or portion of a product taken from a production lot for testing purposes and identifiable and

traceable back to its origin
3.3
specimen
specific portion of the identified sample upon which a test is performed
© ISO 2019 – All rights reserved 1
---------------------- Page: 5 ----------------------
ISO/DIS 17190-2:2019(E)
4 Principle

Residual monomeric sodium acrylate and acrylic acid are extracted from the polyacrylate

superabsorbent powders and the amount determined as residual acrylate monomer by HPLC.

The method described here uses a simple 1-g in 200-ml dilution factor. However, it is equally valid to

use different masses and volumes as long as the mass: volume dilution ratio is the same and suitable

experimental validation is performed.
5 Reagents and Materials
Use only reagents of recognized analytical grade, unless otherwise specified.
5.1 Water
Grade 1 water according to ISO 3696
5.2 Sodium chloride solution

5.2.1 0.9% by mass (m/m) Weigh 9.00 ± 0.01 g of sodium chloride into a 1 l beaker and add 991.0 ± 0.1

g of deionised water (grade 3). Stir until dissolved.

5.2.2 The conductivity of the solution should be checked prior to each use using properly calibrated

measuring equipment. The expected conductivity of a 0,9% saline solution is of the order of 16mS/cm

(depending on temperature). Each testing lab must determine the correct conductivity for the conditions

obtaining in the lab. It is also recommended that the temperature of the solution be maintained at (23

+/- 2) °C for the duration of the test.
5.3 Phosphoric acid
concentrated c(H3P04) = 85% by mass, of HPLC grade or better
5.4 Phosphoric acid solution

c(H3PO4) = 0.1% by mass (1 g/l or 0.0087 mol/l). Dilute concentrated H3PO4 to volume with deionised

water (grade 1). Stir until dissolved.
5.5 Acetonitrile
HPLC grade or better
5.6 Acrylic acid
Greater than 99.5% purity

Acrylic acid degrades over time owing to slow polymerisation, particularly dimerization, and water

uptake. It is important to obtain acrylic acid that meets the purity required for this test method. It is not

recommended to obtain the reference substance from a laboratory chemicals distributor as the purity

of this material from such a source is likely to be inaccurately defined.
6 Apparatus

6.1 Analytical balance, capable of weighing a mass of 100.000 ± 0.001 g of polymer powder in

combination with the mass of the weighing vessel or laboratory paper employed
2 © ISO 2019 – All rights reserved
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ISO/DIS 17190-2:2019(E)
6.2 Analytic
...

INTERNATIONAL ISO
STANDARD 17190-2
Second edition
Urine-absorbing aids for
incontinence — Polyacrylate
superabsorbent powders —
Part 2:
Test method for determination of
the amount of residual acrylate
monomers
Aides pour absorption d'urine — Méthodes d'essai pour caractériser
les matériaux absorbants à base de polymères —
Partie 2: Détermination de la quantité de monomères résiduels
PROOF/ÉPREUVE
Reference number
ISO 17190-2:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 17190-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 17190-2:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Principle ........................................................................................................................................................................................................................ 2

5 Reagents and materials ................................................................................................................................................................................. 2

5.1 Water. ............................................................................................................................................................................................................... 2

5.2 Sodium chloride solution. .............................................................................................................................................................. 2

5.3 Phosphoric acid. ..................................................................................................................................................................................... 2

5.4 Phosphoric acid solution. ............................................................................................................................................................... 2

5.5 Acetonitrile. ............................................................................................................................................................................................... 2

5.6 Acrylic acid. ................................................................................................................................................................................................ 2

6 Apparatus ..................................................................................................................................................................................................................... 3

7 Calibration .................................................................................................................................................................................................................. 4

8 Conditioning .............................................................................................................................................................................................................. 4

9 Sampling ........................................................................................................................................................................................................................ 4

10 Procedure..................................................................................................................................................................................................................... 5

11 Calculation .................................................................................................................................................................................................................. 6

11.1 Calibration curve ................................................................................................................................................................................... 6

11.2 Amount of residual monomers ................................................................................................................................................. 6

12 Report .............................................................................................................................................................................................................................. 7

13 Precision ....................................................................................................................................................................................................................... 7

Annex A (informative) Notes on chromatographical testing ....................................................................................................... 8

Bibliography .............................................................................................................................................................................................................................10

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO 17190-2:2020(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 173, Assistive products, Subcommittee

SC 3, Aids for ostomy and incontinence.

This second edition cancels and replaces the first edition (ISO 17190-2:2001), which has been technically

revised. The main changes compared to the previous edition are as follows:
— full text review and new laboratory analysis with statistical evaluation.
A list of all parts in the ISO 17190 series can be found on the ISO website.

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.
iv PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD ISO 17190-2:2020(E)
Urine-absorbing aids for incontinence — Polyacrylate
superabsorbent powders —
Part 2:
Test method for determination of the amount of residual
acrylate monomers

WARNING — This document does not claim to address all of the safety concerns, if any, associated

with its use. It is the responsibility of the user of this document to establish appropriate safety

and health practices and determine the applicability of regulatory limitations prior to use. It

is expected that the person performing this test has been fully trained in all aspects of this

procedure.
1 Scope

This document provides a test method for determining the sum of residual monomeric sodium acrylate

and acrylic acid present in polyacrylate superabsorbent powders as acrylic acid.
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 187, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for

monitoring the atmosphere and conditioning of samples
ISO 3696, Water for analytical laboratory use — Specification and test methods
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 http:// www .electropedia .org/
3.1
amount of residual monomers
sum of residual monomeric sodium acrylate and acrylic acid
3.2
sample

product or portion of a product taken from a production lot for testing purposes and identifiable and

traceable back to its origin
3.3
specimen
specific portion of the identified sample (3.2) upon which a test is performed
© ISO 2020 – All rights reserved PROOF/ÉPREUVE 1
---------------------- Page: 5 ----------------------
ISO 17190-2:2020(E)
4 Principle

Residual monomeric sodium acrylate and acrylic acid are extracted from the polyacrylate

superabsorbent powders and the amount determined as residual acrylate monomer by HPLC.

The method described here uses a simple 1 g in 200 ml dilution factor. However, it is equally valid to

use different masses and volumes as long as the mass: volume dilution ratio is the same and suitable

experimental validation is performed.
5 Reagents and materials
Use only reagents of recognized analytical grade, unless otherwise specified.
5.1 Water.

Grade 1 water according to ISO 3696, for the standard solutions for the calibration and Grade 3 water

according to ISO 3696, with the exception that the conductivity can be as high as 30 μS/cm, for the

saline solution.
5.2 Sodium chloride solution.

5.2.1 0,9 % mass fraction of sodium chloride solution in water. Weigh (9,00 ± 0,01) g of sodium chloride

into a 1 l beaker and add (991,0 ± 0,1) g of deionized water (grade 3). Stir until dissolved.

5.2.2 The conductivity of the solution should be checked prior to each use using properly calibrated

measuring equipment. The expected conductivity of a 0,9 % saline solution is of the order of 1600 S/m

(depending on temperature). Each testing lab shall determine the correct conductivity for the conditions

obtaining in the lab. It is also recommended that the temperature of the solution be maintained at

(23 ± 2) °C for the duration of the test. As this matches the required laboratory temperature it is not

necessary to record the solution temperature.
5.3 Phosphoric acid.
Concentrated c(H P0 ) = 85 % by mass, of HPLC grade or better.
3 4
5.4 Phosphoric acid solution.

c(H PO ) = 0,1 % by mass (1 g/l or 0,0087 mol/l). Dilute concentrated H PO to volume with deionized

3 4 3 4
water (grade 1). Stir until dissolved.
5.5 Acetonitrile.
HPLC grade or better.
5.6 Acrylic acid.
Greater than 99,5 % purity.

Acrylic acid degrades over time owing to slow polymerization, particularly dimerization, and water

uptake. It is important to obtain acrylic acid that meets the purity required for this test method. It is not

recommended to obtain the reference substance from a laboratory chemicals distributor as the purity

of this material from such a source is likely to be defined inaccurately.
2 PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 17190-2:2020(E)
6 Apparatus

6.1 Analytical balance, capable of weighing a mass of (100,000 ± 0,001) g of polymer powder in

combination with the mass of the weighing vessel or laboratory paper employed.

6.2 Analytical balance, capable of weighing a mass of (9,00 ± 0,01) g of sodium chloride in combination

with the mass of the weighing vessel or laboratory paper employed.

6.3 Analytical balance, capable of weighing a mass of (1000,00 ± 1,00) g of sodium chloride solution

in combination with the mass of the vessel
...