BS EN ISO-8670-2 Ostomy collection bags Test Machine
BS EN ISO-8670-2 – Ostomy collection bags. Requirements and test methods
ISO 8670 consists of the following parts, under the general title Ostomy collections bags:
— Part 1: Vocabulary
— Part 2: Requirements and test methods
Users of this part of ISO 8670 are advised to consider the desirability of third-party certification of product conformity with this part of ISO 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 ISO 9000 series.
This part of ISO 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;
c) urostomy bags.
2 Normative reference
The following standard contains provisions which, through reference in this text, constitute provisions of this part of ISO 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 ISO 8670 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
- ISO 8670-1:1996, Ostomy collection bags — Part 1: Vocabulary.
For the purposes of this part of ISO 8670, the definitions given in ISO 8670-1 and the following definitions apply.
Device that contains a porous material for deodorizing flatus as it escapes from the bag.
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
Flexible container for collecting body effluent from the stoma.
Abnormal opening established on the body surface.
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.