BS EN ISO 8669-2-1997 Urine collection bags Requirements and test methods《尿收集袋 试验方法和要求》.pdf

1、BRITISH STANDARD BS EN ISO 8669-2:1997 Urine collection bags Part 2: Requirements and test methods The European Standard EN ISO 8669-2:1996 has the status of a British Standard ICS 11.040; 11.180BS EN ISO 8669-2:1997 This British Standard, having been prepared under the directionof the Health and En

2、vironment Sector Board, waspublished under the authority of the Standards Board and comes into effect on 15 May 1997 BSI 02-1999 The following BSI references relate to the work on this standard: Committee reference CH/47 Draft for comment 94/508293 DC ISBN 0 580 27419 5 Committees responsible for th

3、is 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 Bri

4、tish 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

5、Care Supplies Managers Royal College of Nursing Royal College of Surgeons of England Amendments issued since publication Amd. No. Date CommentsBS EN ISO 8669-2:1997 BSI 02-1999 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Foreword iii Text of EN ISO 8669-

6、2 1BS EN ISO 8669-2:1997 ii BSI 02-1999 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 Part2: Requirements and test methods, published by the European Committee for Standardizatio

7、n (CEN). It supersedes BS7126-2:1989 and BS 7126-101:1991 which are withdrawn.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 co

8、nfer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 11 andaback cover. This standard has been updated (see copyright date) and may have had am

9、endments incorporated. This will be indicated in the amendment table on theinside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8669-2 December 1996 ICS 11.180 Descriptors: See ISO document English version Urine collection bags Part 2: Requirements and testmethods (ISO 8669-2:

10、1996) Poches de recueil durine Partie2:Prescriptions et mthodes dessai (ISO 8669-2:1996) Urinauffangbeutel Teil 2: Anforderungen und Prfverfahren (ISO 8669-2:1996) This European Standard was approved by CEN on 1996-12-14. CEN members are bound to comply with the CEN/CENELEC Internal Regulations whic

11、h 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 Stand

12、ards 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 stand

13、ards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Cent

14、ral Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN ISO 8669-2:1996 EEN ISO 8669-2:1996 BSI 02-1999 2 Foreword The text of the International Standard ISO 8669-2:1996 has been prepared by Technical Committee ISO/TC173 “Technical systems and aids for

15、 disabled or handicapped persons” in collaboration with Technical Committee CEN/TC293 “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,

16、 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,

17、Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the 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.EN IS

18、O 8669-2:1996 ii BSI 02-1999 Contents Page Foreword iii Introduction 1 1 Scope 1 2 Normative reference 1 3 Definitions 1 4 Requirements 1 5 General test conditions 2 6 Test methods 2 7 Test reports 9 Annex A (normative) Dimensions of urine collection bags 10 Figure 1 Filling system for determination

19、 of test volume 3 Figure 2 Filling system for freedom of leakage test a) and measurement of fillingrate b) 4 Figure 3 Schematic of test for strength of attachment system of bags providedwith cutouts 6 Figure 4 Schematic of test for strength of attachment system of bags providedwith buttons and butto

20、nholes 8 Figure A.1 Typical dimensions of a urine collection bag 11EN ISO 8669-2:1996 BSI 02-1999 iii 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 normall

21、y 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

22、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 requi

23、res approval by at least 75% of the member bodies casting a vote. International Standard ISO8669-2 was prepared by Technical Committee ISO/TC173, Technical systems and aids for disabled or handicapped persons, Subcommittee SC3, Aids for ostomy and incontinence. This second edition cancels and replac

24、es the first editions of ISO8669-2:1988, ISO8669-3:1990 and ISO8669-4:1990, 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

25、part of ISO8669.iv blankEN ISO 8669-2:1996 BSI 02-1999 1 Introduction Users of this part of ISO8669 are advised to consider the desirability of third-party certification of product conformity with this part of ISO8669, based on testing and continuing surveillance, which may be coupled with assessmen

26、t of a suppliers quality system against the appropriate standards in the ISO9000 series. 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: a) urine collection bags intended to be worn on the

27、 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, thr

28、ough reference in this text, constitute provisions of this part of ISO8669. 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 ISO8669 are encouraged to investigate the possibility of applying the most r

29、ecent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 8669-1:1988, Urine collection bags Part1:Vocabulary. 3 Definitions For the purposes of this part of ISO8669, the definitions given in ISO8669-1 and the following d

30、efinitions 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

31、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 (see6.1) 4 Requirements 4.1 R

32、ated volume When measured by the method given in6.1, 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 in6.2, the bag shall not leak. 4.3 Freedom from leakage under load When tested by the method given in6.3, the

33、bag shall not leak. 4.4 Freedom from leakage under impact When tested by the method given in6.4, the bag shall not leak. 4.5 Nonreturn valve If a nonreturn valve is fitted, when tested by the method given in6.5, the reflux flowrate shall not exceed 10ml/min. 4.6 Strength of the attachment system Whe

34、n the attachment system of bags provided with cutouts is tested by the method given in6.6, 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 in6.7, none of the buttons and buttonh

35、oles shall fail to support the bag. When bags provided with integral suspensory systems are tested by the method given in6.8, 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 in6.9, the inlet tubin

36、g 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 in6.10, the water shall start flowing into the bag within 1 min and the average filling rate shall be not less than 10ml/s. 4.9 Dimensions If dimensions

37、 are given, they shall be measured in accordance withAnnex A.EN ISO 8669-2:1996 2 BSI 02-1999 5 General test conditions 5.1 Temperature The standard temperature for testing (atmosphere and reagent) shall be23C 2 C. 5.2 Test samples Testing shall be carried out on product samples as supplied to the e

38、nd user. 6 Test methods 6.1 Test volume 6.1.1 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 6.1.3.1 Graduated cylinders, of capacities to suit the bags being tested and having a measurement

39、accuracy of 2%. 6.1.3.2 Filling system, of arrangement and dimensions shown inFigure 1. To maintain a constant hydrostatic head, the rate of flow into the reservoir of the filling 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 Proce

40、dure 6.1.4.1 Cut the inlet tubing so that the reservoir tap is positioned as close as possible to the bag. NOTEFor 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.

41、NOTEMost bags have a drainage tap through which air can be squeezed out. 6.1.4.3 Measure the distance between bottom and top of the bag (l 4inFigure A.1) and mark a horizontal line at0,75 l 4 , measuring from the bottom of the bag. 6.1.4.4 Suspend a non-body-worn bag using the manufacturers recommen

42、ded suspension system. Suspend a body-worn bag freely in a vertical position, so that the volume of the bag is not restricted. 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 to500mm5mm. Connect t

43、he 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 l 4line, start the stopwatch(6.1.3.3). 6.1.4.8 After 1min but before 1min 10s, close

44、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 b

45、ag 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%. 6.1.5 Test report The test report shall contain the general information specified in clause7, together with the

46、test volume. 6.2 Freedom from leakage without load 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 6.2.2.2 Coloured wat

47、er, comprising tap water coloured by the addition of 0,3g/l of erythrosin(E127). 6.2.2.3 Absorbent material, white. 6.2.3 Apparatus 6.2.3.1 Graduated cylinder, as specified in6.1.3.1. 6.2.3.2 Filling system, of arrangement and dimensions shown inFigure 2. 6.2.4 Procedure 6.2.4.1 Suspend a non-body-w

48、orn bag using the manufacturers 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,

49、and then fully open and close the drainage tap ten times. Empty the bag and close the tap. 6.2.4.3 Using the graduated cylinder and the filling system inFigure 2 with a distance of500mm5mm between the top of the bag and the bottom of the reservoir, add to the bag a volume of coloured water (6.2.2.2) equal to 75% of the test volume (6.1.4.10), ensuring that no air is entrained.EN ISO 8669-2:1996 BSI 02-1999 3 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 sur