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11.180.20 - Aids for incontinence and ostomy

ICS 11.180.20 Details

Aids for incontinence and ostomy

Hilfsmittel fur Ostomie und Urinsammlung

Aides aux incontinents et stomisés

Pripomočki pri stomi in inkontinenci

General Information

Parent
11.180 - Aids for disabled or handicapped persons

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Standardization Organization
Technical Committee
Directive
Mandate
50
SIST
SIST EN ISO 16021:2024(Main)
Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers (ISO 16021:2024)
EN ISO 16021:2024

This document provides guidelines and requirements for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidelines and requirements on creating data collection tools. In particular, it provides a framework for eliciting and recording the views of users and their carers on the acceptability of products. In addition, a product diary is described which can help to quantify some parameters of product use, such as wear times, the mass of urine absorbed by the product and the severity of any leakage from it.
This document does not cover direct comparison between products based on statistical parameters, neither does it provide guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.

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CEN
EN ISO 16021:2024(Main)
Absorbent incontinence products for urine and/or faeces - Basic principles for evaluation of single-use adult products from the perspective of users and caregivers (ISO 16021:2024)
SIST EN ISO 16021:2024

This document provides guidelines and requirements for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidelines and requirements on creating data collection tools. In particular, it provides a framework for eliciting and recording the views of users and their carers on the acceptability of products. In addition, a product diary is described which can help to quantify some parameters of product use, such as wear times, the mass of urine absorbed by the product and the severity of any leakage from it.
This document does not cover direct comparison between products based on statistical parameters, neither does it provide guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.

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ISO
ISO 16021:2024(Main)
Absorbent incontinence products for urine and/or faeces — Basic principles for evaluation of single-use adult products from the perspective of users and caregivers

This document provides guidelines and requirements for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidelines and requirements on creating data collection tools. In particular, it provides a framework for eliciting and recording the views of users and their carers on the acceptability of products. In addition, a product diary is described which can help to quantify some parameters of product use, such as wear times, the mass of urine absorbed by the product and the severity of any leakage from it. This document does not cover direct comparison between products based on statistical parameters, neither does it provide guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.

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    11 pages
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CEN
EN ISO 22748:2021(Main)
Absorbent incontinence products for urine and/or faeces - Product type names and illustrations (ISO 22748:2021)
SIST EN ISO 22748:2021

This document provides recommended and other product type names and example pictures of product categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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ISO
ISO 24669:2021(Main)
Water-absorbent polyacrylate in urine absorbing products — Requirements

This document specifies requirements for water-absorbent crosslinked polyacrylate in urine absorbing products.

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    3 pages
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SIST
SIST EN ISO 22748:2021(Main)
Absorbent incontinence products for urine and/or faeces - Product type names and illustrations (ISO 22748:2021)
EN ISO 22748:2021

This document provides recommended and other product type names and example pictures of product
categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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ISO
ISO 22748:2021(Main)
Absorbent incontinence products for urine and/or faeces — Product type names and illustrations

This document provides recommended and other product type names and example pictures of product categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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ISO
ISO 17190-2:2021(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 2: Test method for determination of the amount of residual acrylate monomers

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.

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ISO
ISO 17190-9:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 9: Test method for gravimetric determination of flow rate and bulk density

This document provides a test method to determine the mass flow rate and bulk density (or apparent density) of polyacrylate superabsorbent powders.

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ISO
ISO 17190-5:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 5: Test method for determination of the free swell capacity in saline by gravimetric measurement

This document provides a test method that determines the free swell capacity of polyacrylate superabsorbent powders in saline solution.

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ISO
ISO 17190-8:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 8: Test method for determination of the permeability dependent absorption under pressure of saline solution by gravimetric measurement

This document provides a test method for measuring the permeability-dependent absorption under pressure (PDAUP) of polyacrylate superabsorbent powder, where permeability is a significant controlling factor under the conditions of the test.

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ISO
ISO 17190-6:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 6: Test method for determination of the fluid retention capacity in saline solution by gravimetric measurement following centrifugation

This document provides a test method for the determination of the fluid retention capacity of polyacrylate superabsorbent powders in saline solution, following centrifugation.

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ISO
ISO 17190-4:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 4: Test method for estimation of the moisture content as weight loss upon heating

This document provides a test method for the evaluation of mass loss upon heating for cross-linked polyacrylate superabsorbent powders. This method is applicable to powdered polymeric superabsorbent materials that are free-flowing under the specified test conditions. Substances other than water that are volatile in this temperature range will interfere. The onus is on the polymer formulator/producer to decide if such interference is possible and either exclude the method from use, provide an alternative or modify the method accordingly.

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ISO
ISO 17190-10:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 10: Test method for determination of extractable polymer content by potentiometric titration

This document provides a test method to determine the mass fraction of soluble polymers present in crosslinked polyacrylate superabsorbent powders that can be extracted into saline solution.

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ISO
ISO 17190-7:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 7: Test method for gravimetric determination of absorption against pressure

This document provides a test method that determines the capacity of polyacrylate superabsorbent powders to absorb saline solution under a specified enclosing pressure.

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ISO
ISO 17190-1:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 1: Test method for determination of pH

This document provides a test method for determining the pH of granular superabsorbent polyacrylates.

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ISO
ISO 17190-3:2020(Main)
Urine-absorbing aids for incontinence — Polyacrylate superabsorbent powders — Part 3: Test method for determination of the particle size distribution by sieve fractionation

This document specifies a test method for measuring particle size distributions up to 850 µ of cross-linked polyacrylate superabsorbent powders. It applies only to measurements made where sieve shaking is used for the separation. Tapping equipment is not expected to deliver the same results. This method is applicable to powdered polymeric superabsorbent materials that are free-flowing under the specified test conditions.

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CEN
EN ISO 15621:2017(Main)
Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)
SIST EN ISO 15621:2017

ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

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SIST
SIST EN ISO 15621:2017(Main)
Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)
EN ISO 15621:2017

This International Standard gives guidelines for evaluating the characteristics of assistive products for absorbing urine and faeces. The standard provides a context for the procedures described in other International Standards and published testing procedures. General factors of incontinence products and their usage are also addressed.

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ISO
ISO 15621:2017(Main)
Absorbent incontinence aids for urine and/or faeces — General guidelines on evaluation
oSIST ISO/DIS 15621:2016

ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

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    12 pages
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ISO
ISO 12505-2:2016(Main)
Skin barrier for ostomy aids — Test methods — Part 2: Wet integrity and adhesive strength

ISO 12505-2:2016 specifies test methods dealing with face plates of skin barriers for ostomy aids. ISO 12505-2:2016 does not cover medical properties (cytotoxicity, sensitization, irritation/intracutaneous reactivity, buffering effect, microbiological effects, etc.).

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ISO
ISO 12505-1:2014(Main)
Skin barrier for ostomy aids — Test methods — Part 1: Size, surface pH and water-absorbency

ISO 12505-1:2014 specifies test methods dealing with a face plate of skin barriers for ostomy aids.

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ISO
ISO 17191:2004(Main)
Urine-absorbing aids for incontinence — Measurement of airborne respirable polyacrylate superabsorbent materials — Determination of dust in collection cassettes by sodium atomic absorption spectrometry

ISO 17191:2004 specifies a method for the determination of polyacrylate (PA) superabsorbent powders in airborne dust by measurement of sodium (Na) by atomic absorption spectrometry (AAS). PA dust samples are collected in polystyrene acrylonitrile air-monitoring cassettes with polytetrafluoroethylene filters and porous plastic backing pads. This method is applicable to the determination of collected superabsorbent powder in the range between 0,2 micrograms and 60 micrograms (limit of detection near 0,2 micrograms) of superabsorbent powders.

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ISO
ISO 17190-11:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 11: Determination of content of respirable particles

This part of ISO 17190 specifies a method for determining the content of respirable particles in polyacrylate (PA) superabsorbent powders. NOTE Commercial polyacrylate superabsorbent powders consist of particles averaging 400 μm to 800 μm in diameter, which are much larger than the maximum size for respirable particles of approximately 10 μm. Due to the production process, very low amounts of respirable particles may be present in commercial superabsorbent powders.

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SIST
SIST EN ISO 8669-2:2000(Main)
Urine collection bags - Part 2: Requirements and test methods (ISO 8669-2:1996)
EN ISO 8669-2:1996

To establish a European standard which specifies test methods and performance requirements for open-ended and close-ended urine collection bags intended to a) be worn on the body; b) be used with a hanger or floor stand.

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SIST
SIST EN ISO 8670-2:2000(Main)
Ostomy collection bags - Part 2: Requirements and test methods (ISO 8670-2:1996)
EN ISO 8670-2:1996

Gives performance requirements and test methods for one-piece and multiple-piece ostomy systems having open-ended and closed-ended collection bags. Replaces the first edition.

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    10 pages
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ISO
ISO 8670-2:1996(Main)
Ostomy collection bags — Part 2: Requirements and test methods

Gives performance requirements and test methods for one-piece and multiple-piece ostomy systems having open-ended and closed-ended collection bags. Replaces the first edition.

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ISO
ISO 8669-2:1996(Main)
Urine collection bags — Part 2: Requirements and test methods

Gives performance requirements and test methods for body-worn and non-body-worn open-ended and closed urine collection bags. Does not apply to urine bags for paediatric uses. Replaces the first editions of ISO 8669-2, ISO 8669-3 and ISO 8669-4.

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ISO
ISO 11948-1:1996(Main)
Urine-absorbing aids — Part 1: Whole-product testing

Gives a method for determining the absorption capacity of the absorbent core of body-worn urine-absorbing aids.

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ISO
ISO 8669-1:1988(Main)
Urine collection bags — Part 1: Vocabulary

Definition of terms used in international Standards of this field; related medical terms are not defined. The terms do not individually or collectively define or recommend a product of special design, style or size. Synonyms are given in an order of preference.

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ISO
ISO 8670-1:1988(Main)
Ostomy collection bags — Part 1: Vocabulary

Definition of terms used in international Standards of this field; related medical terms are not defined. The terms do not individually or collectively define or recommend a product of special design, style or size. Synonyms are given in an order of preference.

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    6 pages
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SIST
oSIST ISO/DIS 15621:2016
Urine-absorbing aids -- General guidelines on evaluation
ISO 15621:2017

ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

  • Standard
    12 pages
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    13 pages
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SIST
SIST EN ISO 16021:2001(Main)
Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers (ISO 16021:2000)
EN ISO 16021:2000

To provide guidelines for designing and conducting a user evaluation of single-use incontinence absorbing aids.

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    13 pages
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SIST
SIST ISO 15621:2016
Urine-absorbing aids -- General guidelines on evaluation
ISO 15621:2011

This International Standard gives general guidelines on the methodology of evaluating disposable urineabsorbing
aids, and provides a context for the procedures described in other International Standards or
published testing procedures. These products are also used for faecal incontinence, which is occasionally
mentioned.

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    11 pages
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SIST
SIST ISO 15621:2005(Main)
Urine-absorbing aids -- General guidance on evaluation
ISO 15621:1999
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    5 pages
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ISO
ISO 15621:2011(Main)
Urine-absorbing aids — General guidelines on evaluation
SIST ISO 15621:2016

ISO 15621:2011 gives general guidelines on the methodology of evaluating disposable urine-absorbing aids, and provides a context for the procedures described in other International Standards or published testing procedures. These products are also used for faecal incontinence, which is occasionally mentioned.

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    11 pages
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ISO
ISO 24214:2006(Main)
Skin barrier for ostomy aids — Vocabulary

ISO 24214:2006 defines terms dealing with skin barriers for ostomy aids as defined below. ISO 24214:2006 does not cover medical terms or general adhesive terms. The terms do not individually or collectively define or recommend a product of a specific design, style or size.

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ISO
ISO 16391:2002(Main)
Aids for ostomy and incontinence — Irrigation sets — Requirements and test methods

This International Standard specifies performance requirements and test methods for irrigation sets, used in colostomy care.

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    7 pages
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ISO
ISO 17190-5:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 5: Gravimetric determination of free swell capacity in saline solution

This part of ISO 17190 specifies a method for the determination of the free swell capacity of polyacrylate (PA) superabsorbent powders in saline solution.

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    6 pages
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    7 pages
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ISO
ISO 17190-3:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 3: Determination of particle size distribution by sieve fractionation

This part of ISO 17190 specifies a method for measuring particle size distributions from 45 μm to 850 μm of cross-linked polyacrylate (PA) superabsorbent powders. In general, this method is expected to be applicable to powdered polymeric superabsorbent materials that are free-flowing at temperatures between 15 °C and 35 °C.

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ISO
ISO 17190-7:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 7: Gravimetric determination of absorption under pressure

This part of ISO 17190 specifies a method for determining the capacity of polyacrylate (PA) superabsorbent powders to absorb saline solution under a specified pressure. This method is applicable to materials having maximum 0,1 % of the particle size distribution below 45 μm.

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ISO
ISO 17190-6:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 6: Gravimetric determination of fluid retention capacity in saline solution after centrifugation

This part of ISO 17190 specifies a method for determining the fluid retention capacity of polyacrylate (PA) superabsorbent powders in saline solution, following centrifugation.

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ISO
ISO 17190-4:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 4: Determination of moisture content by mass loss upon heating

This part of ISO 17190 specifies a method for determining the mass loss upon heating for cross-linked polyacrylate (PA) superabsorbent powders with a moisture content ranging between 0 % and 5 % by mass. The method is accurate to within ± 0,1 %. In general, this method is expected to be applicable to powdered polymeric superabsorbent materials that are free-flowing at temperatures between 15 °C and 150 °C. Substances other than water, that are volatile in this temperature range, will interfere.

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ISO
ISO 17190-1:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 1: Determination of pH

This part of ISO 17190 specifies a method for determining the pH of polyacrylate (PA) superabsorbent powders. This method has been tested in the range of pH 5,92 to pH 6,14 (see annex A), but it is expected to be applicable to a wider range.

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ISO
ISO 17190-2:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 2: Determination of amount of residual monomers

This part of ISO 17190 specifies a method for determining the sum of residual monomeric sodium acrylate and acrylic acid present in polyacrylate (PA) superabsorbent powders as acrylic acid.

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ISO
ISO 17190-10:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 10: Determination of extractable polymer content by potentiometric titration

This part of ISO 17190 specifies a method for determining the mass fraction of carboxylate groups of varying chain length present in polyacrylate (PA) superabsorbent powders which are extractable in saline solution. This method has been tested in the extractable polymer mass fraction range from 5,29 % to 9,00 % (see annex A), but it is expected to be applicable to a wider range.

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ISO
ISO 17190-9:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 9: Gravimetric determination of density

This part of ISO 17190 specifies a method for determining the apparent density of polyacrylate (PA) superabsorbent powders. This method has been tested in the range 0,67 g/ml to 0,72 g/ml (see annex A), but it is expected to be applicable to a wider range.

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ISO
ISO 17190-8:2001(Main)
Urine-absorbing aids for incontinence — Test methods for characterizing polymer-based absorbent materials — Part 8: Gravimetric determination of flowrate

This part of ISO 17190 specifies a method for determining the mass flowrate of polyacrylate (PA) superabsorbent powders. This method has been tested in the range 10,62 g/s to 11,93 g/s (see annex A), but it is expected to be applicable to a wider range of mass flowrates.

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ISO
ISO 16021:2000(Main)
Urine-absorbing aids — Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers
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    11 pages
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ISO
ISO 8670-3:2000(Main)
Ostomy collection bags — Part 3: Determination of odour transmission of colostomy and ileostomy bags
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    4 pages
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