SIST EN ISO 8670-2:2000

Ostomy collection bags - Part 2: Requirements and test methods (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.

Ostomiesammelbeutel - Teil 2: Anforderungen und Prüfverfahren (ISO 8670-2:1996)

Dieser Teil der ISO 8670 legt Prüfverfahren und Gebrauchsanforderungen für ein- und mehrteilige Ostomie-Versorgungssysteme mit Sammelbeuteln folgender Arten fest: (a) geschlossene Beutel; (b) Ausstreifbeutel; (c) Urostomiebeutel.

Poches de recueil pour stomie - Partie 2: Prescriptions et méthodes d'essai (ISO 8670-2:1996)

La présente partie de l'ISO 8670 fixe les prescriptions de performances et les méthodes d'essai correspondantes pour les systèmes une pièce et à éléments multiples pour stomie, équipés de poches de recueil des types suivants: a) poches scellées; b) poches ouvertes; c) poches pour stomie urinaire.

Vrečke za blato - 2. del: Zahteve in preskusne metode (ISO 8670-2:1996)

General Information

• Status: Published
• Publication Date: 31-Dec-1999
• ICS: 11.180.20 - Aids for incontinence and ostomy
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jan-2000
• Due Date: 01-Jan-2000
• Completion Date: 01-Jan-2000
• Ref Project: EN ISO 8670-2:1996 - Ostomy collection bags - Part 2: Requirements and test methods (ISO 8670-2:1996)

Overview

EN ISO 8670-2:1996 - "Ostomy collection bags - Part 2: Requirements and test methods" specifies performance criteria and laboratory test methods for one-piece and multiple-piece ostomy systems with closed-ended, open-ended, and urostomy collection bags. This part defines how to evaluate leakage resistance, closure retention and static burst strength, and sets general test conditions (e.g., standard temperature and sample handling). It is intended for manufacturers, test laboratories, regulators and conformity assessment bodies.

Key topics and technical requirements

• Scope: Applies to one- and multiple-piece ostomy systems; complements ISO 8670-1 (vocabulary).
• Performance requirements:
  • Freedom from leakage: Bags without flanges and systems with flanges must show no leakage when tested by the specified methods.
  • Retention of open-ended closures: Open-ended bag closures must remain in position after compressive loading when used per manufacturer instructions.
  • Burst strength (static): Bags must not leak under a defined compressive load.
  • Marking: Bags must be marked with product code and manufacturer/supplier name or trademark; maximum stoma-opening size must be marked or stated in instructions.
• General test conditions:
  • Standard test temperature: 23 °C ± 2 °C.
  • Tests must be performed on products as supplied to end-users.
• Representative test methods and parameters:
  • Test volume measurement using water and a rigid transparent plate with a 10 mm hole; result defines volumes used in other tests.
  • Leakage tests:
    • Bags without flanges: filled with coloured water (erythrosin 0.3 g/L), inspected vertically and horizontally; includes long-duration soak checks (e.g., 17 h horizontal, 4 h vertical).
    • Systems with flanges: mechanical force 20 N ± 1 N applied up/down, then filled with coloured water and inspected for junction leakage.
  • Retention test: compressive load 100 N ± 5 N for 1 minute to verify closure retention.
  • Burst strength (static): compressive load 200 N ± 5 N for 1 minute to check for leakage.
  • Test reports must document identification, test conditions, number of samples and results.

Applications and users

• Manufacturers and product designers use the standard to design compliant ostomy bags and flange systems and to prepare technical documentation.
• Independent testing laboratories and quality assurance teams apply the specified methods for product verification and certification.
• Regulators, procurement and clinical procurement specialists reference the standard to set acceptance criteria for marketed ostomy products.
• Third‑party certification bodies may use ISO 8670-2 as the basis for conformity assessment and surveillance.

Related standards

• ISO 8670-1:1996 - Ostomy collection bags - Part 1: Vocabulary.
• ISO 9000 series - Quality management system standards referenced for supplier quality assessment.
• CEN adoption: published as EN ISO 8670-2:1996 / SIST EN ISO 8670-2:2000 in national catalogs.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2000
9UHþNH]DEODWRGHO=DKWHYHLQSUHVNXVQHPHWRGH,62
Ostomy collection bags - Part 2: Requirements and test methods (ISO 8670-2:1996)
Ostomiesammelbeutel - Teil 2: Anforderungen und Prüfverfahren (ISO 8670-2:1996)
Poches de recueil pour stomie - Partie 2: Prescriptions et méthodes d'essai (ISO 8670-
2:1996)
Ta slovenski standard je istoveten z: EN ISO 8670-2:1996
ICS:
11.180.20 9UHþNH]DEODWRLQXULQVNH Aids for ostomy and
YUHþNH incontinence
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL IS0
STANDARD
8670-2
Second edition
1996-12-15
Ostomy collection bags -
Part 2:
Requirements and test methods
Poches de recueil pour stomie -
Parfie 2: Prescriptions et m&hodes d’essai
Reference number
IS0 8670-2:1996(E)
IS0 8670-2: 1996(E)
Page
Contents
. . .~.
1 Scope
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Normative reference
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 Requirements
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 General test conditions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 Test methods
Test reports ,.
0 IS0 1996
Ail 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
central @ isocs.iso.ch
Internet:
x.400: c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii
IS0 8670=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 8670-Z was prepared by Technical Committee
ISO/TC 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 edition
(IS0 8670-2:1991) which has been technically revised.
IS0 8670 consists of the following parts, under the general title Ostomy
collections bags:
- Par? 1: Vocabulary
- Pat? 2: Requirements and test methods
. . .
III
IS0 8670=2:1996(E) 0 IS0
Introduction
Users of this part of IS0 8670 are advised to consider the desirability of
third-party certification of product conformity with this part of IS0 8670,
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.
IV
INTERNATIONAL STANDARD 0 IS0 IS0 8670-2: 1996(E)
Ostomy collection bags -
Part 2:
Requirements and test methods
1 Scope
This part of IS0 8670 specifies performance requirements and test methods for one-piece and multiple-piece
ostomy systems having collection bags of the following types:
a) closed-ended bags;
b) open-ended bags;
urostomy bags.
0)
2 Normative reference
The following standard contains provisions which, through reference in this text, constitute provisions of this part of
IS0 8670. 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 8670 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 8670-l :1996, Ostomy collection bags - Part 1: Vocabulary.
3 Definitions
For the purposes of this part of IS0 8670, the definitions given in IS0 8670-l and the following definitions apply.
3.1 flatus filter: Device that contains a porous material for deodorizing flatus as it escapes from the bag.
3.2 multiple-piece flange system: Effluent collection system in which a component is positioned around the
stoma allowing an effluent collection bag to be attached or removed while the component itself remains in position.
3.3 ostomy bag: Flexible container for collecting body effluent from the stoma.
3.4 stoma: Abnormal opening established on the body surface.
3.5 test volume: That volume on which is based the volume of liquid added, or the force applied, to an ostomy
collection bag when performing tests to verify the strength and leakage resistance of the bag assembly.

IS0 8670-2: 1996(E)
4 Requirements
4.1 Freedom from leakage
4.1.1 When tested by the method given in 6.2, bags without flanges shall not leak.
4.1.2 When tested by the method given in 6.3, bags (systems) with flanges shall not leak.
4.2 Retention of open-ended bag closure
When tested by the method given in 6.4, the open-ended bag closure shall remain in position when used following
the bag manufacturer’s instructions.
4.3 Burst strength (static)
When tested by the method given in 6.5, the bag shall not leak.
4.4 Marking of the ostomy collection system
4.4.1 For identification purposes, the bag shall be marked with at least the product code and the name and/or
trademark of the manufacturer or supplier.
4.4.2 If the opening for the stoma is intended to be enlarged, the maximum opening shall be either
a) marked on the product
or
b) given in the instructions.
5 General test conditions
5.1 Temperature
The standard temperature for testing (atmosphere and reagent) shall be 23 “C + 2 “C.
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 ostomy 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.
0 IS0 IS0 8670-2: 1996(E)
6.1.3 Apparatus
6.1.3.1 Rigid transparent plate (see figure l), of sufficient size to support the whole of the bag in the horizontal
position, having a hole of diameter 10 mm IfI 0,2 mm to which a connector fitted with a tap can be secured.
6.1.3.2 Means of filling the bag, from the tap or reservoir, ensuring that air is not entrained.
6.1.3.3 Graduated cylinders, of capacities to suit the bags being tested and having a measurement accuracy of
+ 2 Oh.
Dimensions in millimetres
To water supply -
Transparenttestplate
Figure 1 - Set-up for measuring test volume
6.1.4 Procedure
6.1.4.1 For open-ended bags with a bottom opening, close the outlet 30 mm + 5 mm from the bottom by welding
or by repeated folding secured with a binder clip or other securing device not exceeding 100 g in mass. For open-
ended bags with a top opening, close the opening in accordance with the manufacturer’s instructions.
Do not use a rubber band for closure purposes.
@ IS0
IS0 8670-2: 1996(E)
6.1.4.2 If there is no precut opening in the ostomy bag assembly, or if the opening is of diameter less than
15 mm, cut a central hole of diameter 15 mm ‘g mm.
6.1.4.3 With the rigid transparent test plate (6.1.3.1) in a vertical position, attach the ostomy bag assembly so the
bag opening is concentric with the hole in the test plate. Ensure that the bag is positioned so that its movement is
not restricted.
Remove as much air as possible from the ostomy bag under test. In the case of urostomy bags, this may
6.1.4.4
mean opening the drainage tap while pressing against the bag, and then closing the drainage tap.
Insert the filling connector (6.1.3.2) into the test plate with the tap in the clo
...