ISO/TC 173/SC 3 - Aids for ostomy and incontinence
Aides pour ostomie et incontinence
General Information
This document specifies requirements for water-absorbent crosslinked polyacrylate in urine absorbing products.
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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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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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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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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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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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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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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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This document provides a test method for determining the pH of granular superabsorbent polyacrylates.
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This document provides a test method that determines the free swell capacity of polyacrylate superabsorbent powders in saline solution.
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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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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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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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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 12505-1:2014 specifies test methods dealing with a face plate of skin barriers for ostomy aids.
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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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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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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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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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Gives a method for determining the absorption capacity of the absorbent core of body-worn urine-absorbing aids.
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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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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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This International Standard specifies performance requirements and test methods for irrigation sets, used in colostomy care.
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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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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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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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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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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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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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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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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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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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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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