National foreword

This British Standard has been prepared by Technical Committee CH/47, and is the English language version of EN ISO 8669‑2:1996 Urine collection bags — Part 2: Requirements and test methods, published by the European Committee for Standardization (CEN). It supersedes BS 7126‑2:1989 and BS 7126‑101:1991 which are withdrawn.

A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

Foreword

The text of the International Standard ISO 8669‑2:1996 has been prepared by Technical Committee ISO/TC 173 “Technical systems and aids for disabled or handicapped persons” in collaboration with Technical Committee CEN/TC 293 “Technical aids for disabled persons”, the secretariat of which is held by SIS.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 1997, and conflicting national standards shall be withdrawn at the latest by June 1997.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO 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. ISO 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 ISO 8669‑2 was prepared by Technical Committee ISO/TC173, 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 ISO 8669‑2:1988, ISO 8669‑3:1990 and ISO 8669‑4:1990, which have been technically revised.

ISO 8669 consists of the following parts, under the general title Urine collection bags:

Part 1: Vocabulary
Part 2: Requirements and test methods

Annex A forms an integral part of this part of ISO 8669.

Introduction

Users of this part of ISO 8669 are advised to consider the desirability of third-party certification of product conformity with this part of ISO 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 ISO 9000 series.

This European Standard was approved by CEN on 1996-12-14. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member.

The European Standards exist in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice

The text of the International Standard ISO 8669‑2:1996 was approved by CEN as a European Standard without any modification.

Committees responsible for this British Standard

The preparation of this British Standard was entrusted by Technical Committee CH/47, Aids for ostomy and incontinence, upon which the following bodies were represented:

Association of Continence Advisors
British Association of Urological Surgeons
British Colostomy Association
British Surgical Trades Association
Chartered Society of Physiotherapy
Department of Health
Guild of Hospital Pharmacists
Ileostomy Association of Great Britain and Ireland
Infection Control Nurses Association
Medical Research Council
Medical Sterile Products Association
National Association of Health Care Supplies Managers
Royal College of Nursing
Royal College of Surgeons of England

1 Scope

This part of ISO 8669 specifies performance requirements and test methods for open-ended and closed-ended urine collection bags of the following types:

urine collection bags intended to be worn on the body (body-worn bags);
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

3 Definitions

4 Requirements

4.1 Rated volume

4.2 Freedom from leakage without load

4.3 Freedom from leakage under load

4.4 Freedom from leakage under impact

4.5 Nonreturn valve

4.6 Strength of the attachment system

4.7 Strength of attachment of the inlet tubing

4.8 Pressure/time required to initiate flow into the bag and filling rate

4.9 Dimensions

5 General test conditions

5.1 Temperature

5.2 Test samples

6 Test methods

6.1 Test volume

6.2 Freedom from leakage without load

6.3 Freedom from leakage under load

6.4 Freedom from leakage under impact

6.5 Nonreturn valve

6.6 Strength of the attachment system of bags provided with cutouts

6.7 Strength of the attachment system of bags provided with a button and buttonhole system

6.8 Strength of integral suspensory systems

6.9 Strength of attachment of the inlet tubing

6.10 Pressure/time required to initiate flow into the bag and filling rate

7 Test reports

BS EN ISO 8669-2:1997

Urine collection bags - Requirements and test methods

Current

Published:

15 May 1997