SIST EN ISO 8669-2:2000
(Main)Urine collection bags - Part 2: Requirements and test methods (ISO 8669-2:1996)
Urine collection bags - Part 2: Requirements and test methods (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.
Urinauffangbeutel - Teil 2: Anforderungen und Prüfverfahren (ISO 8669-2:1996)
Dieser Teil der ISO 8669 legt Prüfverfahren und Gebrauchsanforderungen für entleerbare und geschlossene Urinauffangbeutel folgender Arten fest: a)Urinauffangbeutel, die zum Tragen am Körper bestimmt sind (körpertragebeutel); b)Urinauffangbeutel, die zur Benutzung an einem Aufhänger oder einem Bodenständer bestimmt sind (Aufhängebeutel). Er gilt nicht für Urostomiebeutel, Urinmeßbeutel und Urinbeutel, die zur Verwendung in der Pädiatrie bestimmt sind.
Poches de recueil d'urine - Partie 2: Prescriptions et méthodes d'essai (ISO 8669-2:1996)
La présente partie de l'ISO 8669 fixe les prescriptions de performances et les méthodes d'essai correspondantes pour les poches de recueil d'urine, à extrémité ouverte et à extrémité fermée, des types suivants: a) poches de recueil d'urine destinées à être portées sur le corps (poches portées à même le corps); b) poches de recueil d'urine destinées à être utilisées avec un support ou une potence (poches non portées à même le corps). Elle n'est pas applicable aux poches pour urostomie, ni aux urimètres, ni aux poches de recueil d'urine spécialement destinées à être utilisés en pédiatrie.
Urinske vrečke - 2. del: Zahteve in preskusne metode (ISO 8669-2:1996)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8669-2:2000
01-januar-2000
8ULQVNHYUHþNHGHO =DKWHYHLQSUHVNXVQHPHWRGH ,62
Urine collection bags - Part 2: Requirements and test methods (ISO 8669-2:1996)
Urinauffangbeutel - Teil 2: Anforderungen und Prüfverfahren (ISO 8669-2:1996)
Poches de recueil d'urine - Partie 2: Prescriptions et méthodes d'essai (ISO 8669-
2:1996)
Ta slovenski standard je istoveten z: EN ISO 8669-2:1996
ICS:
11.180.20 9UHþNH]DEODWRLQXULQVNH Aids for ostomy and
YUHþNH incontinence
SIST EN ISO 8669-2:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8669-2:2000
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SIST EN ISO 8669-2:2000
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SIST EN ISO 8669-2:2000
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SIST EN ISO 8669-2:2000
INTERNATIONAL IS0
STANDARD 8669-2
Second edition
1996-l 2-l 5
Urine collection bags -
Part 2:
Requirements and test methods
Poches de recueil d ’urine -
Parfie 2: Prescriptions et mkthodes d ’essai
Reference number
IS0 8669-2: 1996(E)
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SIST EN ISO 8669-2:2000
IS0 8669-2: 1996(E)
Page
Contents
1
1 Scope .
1
2 Normative reference .
1
3 Definitions .
2
............................................................................
4 Requirements
2
5 General test conditions .
.............................................................................. 3
6 Test methods
13
7 Test reports .
Annex
14
A Dimensions of urine collection bags .
0 IS0 1996
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-1211 Geneve 20 l Switzerland
Internet: central @ isocs.iso.ch
x.400: c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii
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SIST EN ISO 8669-2:2000
IS0 8669-2: 1996(E)
@ IS0
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work of
preparing International Standards is normally carried out through IS0
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. IS0
collaborates closely with the international Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 8669-2 was prepared by Technical Committee
ISOITC 173, Technical systems and aids for disabled or handicapped
persons, Subcommittee SC 3, Aids for ostomy and incontinence.
This second edition cancels and replaces the first editions of
IS0 8669-2:1988, IS0 8669-3:1990 and IS0 8669-4:1990, which have
been technically revised.
IS0 8669 consists of the following parts, under the general title Urine
collection bags:
- Part I: Vocabulary
- Part 2: Requirements and test methods
Annex A forms an integral part of this part of IS0 8669.
. . .
III
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SIST EN ISO 8669-2:2000
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@ IS0
Introduction
Users of this part of IS0 8669 are advised to consider the desirability of
third-party certification of product conformity with this part of IS0 8669,
based on testing and continuing surveillance, which may be coupled with
assessment of a supplier ’s quality system against the appropriate
standards in the IS0 9000 series.
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SIST EN ISO 8669-2:2000
~~
INTERNATIONAL STANDARD @ IS0 IS0 8669-2: 1996(E)
Urine collection bags -
Part 2:
Requirements and test methods
1 Scope
This part of IS0 8669 specifies performance requirements and test methods for open-ended and closed-ended
urine collection bags of the following types:
a) urine collection bags intended to be worn on the body (body-worn bags);
b) urine collection bags intended to be used with a hanger or a floor stand (non-body-worn bags).
It does not apply to urostomy bags, urimeters and urine bags intended specifically for paediatric use.
2 Normative reference
The following standard contains provisions which, through reference in this text, constitute provisions of this part of
IS0 8669. At the time of publication, the edition indicated was valid. All standards are subject to revision, and
parties to agreements based on this part of IS0 8669 are encouraged to investigate the possibility of applying the
most recent edition of the standard indicated below. Members of IEC and IS0 maintain registers of currently valid
International Standards.
IS0 8669-l :I 988, Urine collection bags - Part 1: Vocabulary.
3 Definitions
For the purposes of this part of IS0 8669, the definitions given in IS0 8669-l and the following definitions apply.
3.1 closed-ended urine collection bag: Flexible container for collecting urine, without an opening for drainage of
the contents.
3.2 open-ended urine collection bag: Flexible container for collecting urine, with an opening for drainage of the
contents.
3.3 rated volume: Capacity of the bag, expressed in millilitres, as stated by the manufacturer.
3.4 test volume: That volume on which is based the volume of liquid added, or the force applied, to a urine
collection bag when performing tests to verify the strength and leakage resistance of the bag assembly (see 6.1).
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SIST EN ISO 8669-2:2000
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4 Requirements
4.1 Rated volume
When measured by the method given in 6.1, the bag shall have a rated volume not larger than the test volume.
4.2 Freedom from leakage without load
When tested by the method given in 6.2, the bag shall not leak.
4.3 Freedom from leakage under load
When tested by the method given in 6.3, the bag shall not leak.
4.4 Freedom from leakage under impact
When tested by the method given in 6.4, the bag shall not leak.
4.5 Nonreturn valve
If a nonreturn valve is fitted, when tested by the method given in 6.5, the reflux flowrate shall not exceed 10 ml/min.
4.6 Strength of the attachment system
When the attachment system of bags provided with cutouts is tested by the method given in 6.6, none of the
attachment points shall fail to support the bag.
When the attachment system of bags provided with a button and buttonhole system is tested by the method given in
6.7, none of the buttons and buttonholes shall fail to support the bag.
When bags provided with integral suspensory systems are tested by the mehod given in 6.8, no part of the integral
suspensory system shall fail to support the bag.
4.7 Strength of attachment of the inlet tubing
When tested by the method given in 6.9, the inlet tubing shall not become detached from the bag.
4.8 Pressure/time required to initiate flow into the bag and filling rate
When tested by the method given in 6.10, the water shall start flowing into the bag within 1 min and the average
filling rate shall be not less than 10 ml/s.
4.9 Dimensions
If dimensions are given, they shall be measured in accordance with annex A.
5 General test conditions
5.1 Temperature
The standard temperature for testing (atmosphere and reagent) shall be 23 OC + 2 OC.
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5.2 Test samples
Testing shall be carried out on product samples as supplied to the end user.
6 Test methods
6.1 Test volume
6.1 .l Principle
The urine collection bag is filled with water and the volume of water within the bag is measured.
6.1.2 Reagent
6.1.2.1 Tap water
6.1.3 Apparatus
Graduated cylinders, of capacities to suit the bags being tested and having a measurement accuracy of
6.1.3.1
+ - 2 %.
6.1.3.2 Filling system, of arrangement and dimensions shown in figure 1.
To maintain a constant hydrostatic head, the rate of flow into the reservoir of the fillling system shall be higher than
the rate of the filling of the bag.
6.1.3.3 Stopwatch, or similar timing device.
6.1.4 Procedure
6.1.4.1 Cut the inlet tubing so that the reservoir tap is positioned as close as possible to the bag.
NOTE - For bags having extensible tubing, these should be drawn out to their maximum length before cutting.
6.1.4.2 Remove as much air as possible from the bag. Close the drainage tap afterwards.
Most bags have a drainage tap through which air can be squeezed out.
NOTE -
6.1.4.3 Measure the distance between bottom and top of the bag (Z4 in figure A.l) and mark a horizontal line at
0,75 14, measuring from the bottom of the bag.
a non-body-worn bag using th e manufact urer ’s recommended suspension system. Suspend a
6 .1.4.4 Suspe nd
ody-worn bag fre ely in a vertical position , so that the volume of the bag is not restricted.
b
6.1.4.5 Using the filling system (6.1.3.2), ensure that the reservoir tap is closed, turn on the water supply (6.1.2.1)
and adjust the hydrostatic head to 500 mm + 5 mm. Connect the reservoir tap to the inlet tubing of the bag.
6.1.4.6 Open the reservoir tap and allow water to enter the bag, ensuring that no air is entrained.
6.1.4.7 When the water level inside the bag has risen to the 0,75 Z4 line, start the stopwatch (6.1.3.3).
6.1.4.8 After 1 min but before 1 min 10 s, close the reservoir tap.
6.1.4.9 Visually inspect the bag to determine whether or not leakage has occurred. If leakage has occurred, deem
the test invalid and repeat it, using a fresh bag if necessary.
6.1.4.10 Clamp the inlet tubing as close to the filling top surface of the bag as possible. Remove the bag from the
filling system and empty the water from the bag into a graduated cylinder (6.1.3.1). Measure the volume, in
millilitres, and record it as the test volume to an accuracy of + 2 %.
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6.1.5 Test report
The test report shall contain the general information specified in clause 7, together with the test volume.
Dimensions in millimetres
@ d (inside diameter)
Water infiow -
- Overflow
-
Reservoir with
baffles to eliminate
vortex
Connectin g tubing
voir tap
Reser
/------ Urine collection bag
d 2 largest internal diameter of inlet tubing of bag.
NOTE -
Figure 1 - Filling system for determination of test volume
Freedom from leakage without load
6.2
6.2.1 Principle
The urine collection bag is filled with coloured water, positioned horizontally and examined for leakage. It is then
suspended vertically and again inspected visually for leakage.
6.2.2 Reagents
6.2.2.1 Tap water
Coloured water, comprising tap water coloured by the addition of 0,3 g/l of erythrosin (E 127).
6.2.2.2
6.2.2.3 Absorbent material, white.
6.2.3 Apparatus
6.2.3.1 Graduated cylinder, as specified in 6.1.3.1.
6.2.3.2 Filling system, of arrangement and dimensions shown in figure 2.
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SIST EN ISO 8669-2:2000
IS0 8669-2: 1996(E)
Dimensions in millimetres
Plan view of reservoir
showing vertical dividers
to eliminate vortex
Dimensions sufficient
for reservoir to contain
liquid volume equal
C
tothatofthelargest
t--- Iso +2
- bag to be tested
Reservo
/-- Urine collection bag
/
Figure 2 - Filling system for freedom of leakage test (a) and measurement of filling rate (b)
6.2.4 Procedure
6.2.4.1 Suspend a non-body-worn bag using the manufacturer ’s recommended suspension system. Suspend a
body-worn bag freely, so that the volume of the bag is not restricted.
6.2.4.2 If the bag is fitted with a drainage tap, add a small volume of the water (6.2.2.1) into the bag, open the
drainage tap and allow the bag to drain, and then fully open and close the drainage tap ten times. Empty the bag
and close the tap.
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Using the graduated cylinder and the filling system in figure 2 with a distance of 500 mm + 5 mm between
6.2.4.3
the top of the bag and the bottom of the reservoir, add to the bag a volume of coloured water (622.2) equal to 75 %
of the test volume (6.1.4.10), ensuring that no air is entrained.
6.2.4.4 Seal the inlet tubing and, if present, the air vent.
6.2.4.5 Place the absorbent material (6.2.2.3) on a flat surface. Remove the bag from the suspension system and
place it horizontally on the absorbent material.
6.2.4.6 Leave the bag undisturbed for 17 h + 1 h and then visually inspect the bag and absorbent material for
staining caused by leakage. If staining is observed, the urine collection bag under test is deemed to have failed.
6.2.4.7 Reposition the bag under test in a vertical position, as described in 6.2.4.1, above absorbent material.
6.2.4.8 Leave the bag undisturbed for 4 h & 1 h, then visually inspect the bag and absorbent material for staining
caused by leakage. If staining is observed, the urine collection bag under test is deemed to have failed.
6.2.5 Test report
The test report shall contain the general information specified in clause 7, together with a statement as to whether
or not leakage was observed and, if so, from where the leakage occurred and at which orientation of the bag.
6.3 Freedom from leakage under load
6.3.1 Principle
Coloured water is added to the uring collection bag under test, which is then subjected to a compressive load
between two parallel plates. The bag is then visually inspected for leakage.
6.3.2 Reagent
6.3.2.1 Coloured water, as specified in 6.2.2.2.
6.3.2.2 Absorbent material, white.
6.3.3 Apparatus
Graduated cylinder, as specified in 6.1.3.1.
6.3.3.1
6.3.3.2 Filling system, of arrangement and dimensions shown in figure 2.
6.3.3.3 Flat, rigid plate, of length and width not less than those of the bag being tested.
6.3.3.4 Restraints, capable of allowing the plate to move freely in a vertical direction whilst remaining horizontal
within a tolerance of + 5O.
6.3.3.5 Weights, or other means of loading the plate, to produce total downward force of 200 N k 10 N on the bag.
6.3.3.6 Stopwatch, or similar timing device.
6.3.4 Procedure
6.3.4.1 Add coloured water (6.3.2.1) to the bag, as specified in 6.2.4.3.
6.3.4.2 Seal the inlet tubing and, if present, the air vent.
6.3.4.3 Place the absorbent material (6.3.2.2) on a horizontal, flat rigid surface. Place the bag horizontally on the
absorbent material.
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IS0 8669-2: 1996(E)
6.3.4.4 Place the flat, rigid plate (6.3.3.3) on the top of the bag, position the restraints (63.34) and load the plate
gently with the weights (6.3.3.5) so that a total force of 200 N + 10 N is imposed on the bag.
6.3.4.5 Allow t
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