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A critical investigation of ISO 11948-2 and ISO 11948-1 for predicting the leakage performance of small disposable incontinence pads for lightly incontinent women

A critical investigation of ISO 11948-2 and ISO 11948-1 for predicting the leakage performance of small disposable incontinence pads for lightly incontinent women
A critical investigation of ISO 11948-2 and ISO 11948-1 for predicting the leakage performance of small disposable incontinence pads for lightly incontinent women
ISO 11948-2 – an international standard laboratory method developed to predict the leakage performance of small disposable pads for lightly incontinent women – was investigated. The repeatability and reproducibility (precision within and between laboratories, respectively) of two variants on the method were found to be poor. The coefficient of variation for each method variant in each laboratory (two laboratories ran each variant) was higher than 40% for about half the 12 products evaluated. Results differed by up to 94% between laboratories for a given product. The ability of the method to predict the leakage performance of pads was investigated by measuring correlations between the clinical evaluations of the 12 products, and technical evaluations using ISO 11948-2. Correlations were very weak (r ? 0.487). Accordingly, it is recommended that 11948-2 is withdrawn.
A second international standard method (ISO 11948-1) – developed for evaluating large pads, but sometimes used on small ones – was also investigated. Correlations between the clinical evaluations of the 12 products and technical evaluations using ISO 11948-1 were weak (r ? 0.560). Accordingly, it is recommended that ISO 11948-1 is not used for evaluating small disposable bodyworn pads for women.
leakage performance, incontinence pads, incontinent women
1350-4533
42-48
Cottenden, A.M.
264b07aa-fe35-4045-ab3f-e61f2cb9ebe8
Rothwell, J.G.
0dbce601-f721-4c50-8b24-cc52b84d1ec0
Leander, H.
d96b48b8-5a94-40a3-8f0f-7081f7487b3f
Landeryou, M.A.
8c11ee55-c7a2-406c-8dc6-f8be12b98b69
Fader, M.
c318f942-2ddb-462a-9183-8b678faf7277
Pettersson, L.
5b52b4ef-3d89-493a-92d3-e4c4752107ea
Brooks, R.J.
00b6da81-6df3-4f17-a53b-7bc4c437a041
Cottenden, A.M.
264b07aa-fe35-4045-ab3f-e61f2cb9ebe8
Rothwell, J.G.
0dbce601-f721-4c50-8b24-cc52b84d1ec0
Leander, H.
d96b48b8-5a94-40a3-8f0f-7081f7487b3f
Landeryou, M.A.
8c11ee55-c7a2-406c-8dc6-f8be12b98b69
Fader, M.
c318f942-2ddb-462a-9183-8b678faf7277
Pettersson, L.
5b52b4ef-3d89-493a-92d3-e4c4752107ea
Brooks, R.J.
00b6da81-6df3-4f17-a53b-7bc4c437a041

Cottenden, A.M., Rothwell, J.G., Leander, H., Landeryou, M.A., Fader, M., Pettersson, L. and Brooks, R.J. (2006) A critical investigation of ISO 11948-2 and ISO 11948-1 for predicting the leakage performance of small disposable incontinence pads for lightly incontinent women. Medical Engineering & Physics, 28 (1), 42-48. (doi:10.1016/j.medengphy.2005.03.006).

Record type: Article

Abstract

ISO 11948-2 – an international standard laboratory method developed to predict the leakage performance of small disposable pads for lightly incontinent women – was investigated. The repeatability and reproducibility (precision within and between laboratories, respectively) of two variants on the method were found to be poor. The coefficient of variation for each method variant in each laboratory (two laboratories ran each variant) was higher than 40% for about half the 12 products evaluated. Results differed by up to 94% between laboratories for a given product. The ability of the method to predict the leakage performance of pads was investigated by measuring correlations between the clinical evaluations of the 12 products, and technical evaluations using ISO 11948-2. Correlations were very weak (r ? 0.487). Accordingly, it is recommended that 11948-2 is withdrawn.
A second international standard method (ISO 11948-1) – developed for evaluating large pads, but sometimes used on small ones – was also investigated. Correlations between the clinical evaluations of the 12 products and technical evaluations using ISO 11948-1 were weak (r ? 0.560). Accordingly, it is recommended that ISO 11948-1 is not used for evaluating small disposable bodyworn pads for women.

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More information

Published date: January 2006
Keywords: leakage performance, incontinence pads, incontinent women

Identifiers

Local EPrints ID: 58951
URI: http://eprints.soton.ac.uk/id/eprint/58951
ISSN: 1350-4533
PURE UUID: 1afefb3b-6926-4844-abe4-c0707d321705

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Date deposited: 19 Aug 2008
Last modified: 13 Mar 2019 20:31

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Contributors

Author: A.M. Cottenden
Author: J.G. Rothwell
Author: H. Leander
Author: M.A. Landeryou
Author: M. Fader
Author: L. Pettersson
Author: R.J. Brooks

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