EN ISO 8669-2-1996 Urine Collection Bags - Part 2 Requirements and Test Methods《尿收集袋 第2部分 要求与测试方法 ISO 8669-2-1996》.pdf

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1、STD-BSI BS EN IS0 bb-2-ENGL 1997 Lb24bb Ob1bbO 481 m BRITISH STANDARD Urine collection bags Part 2. Requirements and test methods The European Stzdard EN IS0 8669-2 : 19% has thc 11.180 BS EN IS0 8669-2 : 1997 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW ., - STD-BSI BS EN

2、IS0 8bb9-2-ENGL 1997 m 1b24bb7 DbLbbLO ZTL m BS EN IS0 8669-2 : 1997 Committees responsible for this British Standard The preparation of this British Standard was entrusted by Technical Committee CW47, Aids for ostomy and incontinence, upon which the following bodies were represented: Association of

3、 Continence Advisors British Association of Urological Surgeons British Colostomy Association British Surgical lbdes Association Chartered Society of Physiotherapy Department of Health Guild of Hospital Phamaists ieostomy Association of Great Britain and Ireland Infection Control Nurses Association

4、Medical Research Council Medical Sterile Products Association National Association of Health Care Supplies Managers Royal College of Nursing Royal College of Surgeons of England This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published

5、under the authority of the Standards Board and comes into effect on 15 May 1997 O BSI 1997 Amendments issued since publication I Amd. No. I Te* affected The following BSI references relate to the work on this standard Committee reference CW47 Draft for comment 94608293 DC ISBN O 680 27419 6 - STD-BS

6、I BS EN IS0 BbLY-2-ENGL 1797 Lb2LibbY ObLbbLL 018 BS EN IS0 8669-2 : 1997 National foreword This British Standard has been prepared by Technical Committee CW47, and is the English hguage version of EN IS0 8669-2 : 1996 Urine coUect.ion bugs - Part 2 I Requirements and test methods, published by the

7、European Committee for Standardization (CEN). It supersedes BS 7126 : Part 2 : 1989 and BS 7126 : Part 101 : 1991 which are withdrawn. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cnver, an inside front

8、 cover, pages i and ii, EN title pzge md forewcxd, IS0 tit!e page, pges ii to iv, pages 1 to 16, an inside back cover and a back cover. O BSI 1997 i STD.BS1 BS EN IS0 bb9-2-ENGL 1977 E Lb29hbS OblbbL2 T74 131 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN IS0 8669-2 Decernber 1996 ICs 11.180 D

9、escriptors: see IS0 document English version Urine collection bags - Part 2: Requirements and test methods (IS0 8669-2: 1 996) Poches de recueil durine - Partie 2: Prescriptions et mthodes dessai (IS0 8669-2:1996) Urinauffangbeutel - Teil 2: Anforderungen und Prfverfahren (IS0 8669-2:1996) This Euro

10、pean 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 concer

11、ning 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 la

12、nguage and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Derunark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netheriands, Norway, Portugal, Spain, Sweden, Switzerland a

13、nd United Kingdom. CEN European Comnittee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de StassartJ 8-1050 Brussels I-.-. *.- -.- I- 0 1996 Copyright reserved to CEk members Ref. No. EN IS0 8669-2:1996 E STD-BSI BS EN IS0 Bbbq-Z-ENGL 1797

14、 I Lb24bb7 ObLbbL3 900 EN IS0 8669-2 : 1996 Foreword The text of the International Standard IS0 866921996 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 disa

15、bled 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.

16、 According to the CENKENELEC 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, Sw

17、eden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard IS0 8669-2:1996 was approved by CEN as a European Standard without any modification. STD.BS1 BS EN IS0 8bb9-2-ENGL 1797 1b24bbS ObLbbZ4 847 EN IS0 8669-2 : 1996 INTERNATIONAL STANDARD IS0 8669-2 Secon

18、d edition 1996-12-15 Urine collection bags - Part 2: Requirements and test methods Poches de recueil durhe - Partie 2: Prescriptions et mthodes dessai Reference number IS0 8669-2:1996(E) - STD-BSI BS EN IS0 8bb7-2-ENGL 1777 W Lb2LibbS ObLbbl15 783 M EN IS0 8669-2 : 1996 Con tents Page 1 Scope 1 1 2

19、Normative reference 3 Definitions . 1 4 Requirements 2 5 General test conditions 2 6 Test methods 3 7 Test reports 13 Annex A Dimensions of urine collection bags . 14 * * u) - - STD-BSI BS EN IS0 Bbb7-2-ENGL 1777 LbEqbb7 OblbbLb bLT E EN IS0 8669-2 : 1996 Foreword IS0 (the International Organization

20、 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

21、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

22、 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 ISO/TC 1

23、73, 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

24、following parts, under the general title Urine collection bags: - Part I: iocabulaw - Part 2: Requirements and rest methods Annex A forms an integral part of this part of IS0 8669. iii Introduction Users of this part of IS0 8669 are advised to consider the desirability of third-party certification o

25、f product conformity with this part of IS0 8669, based on testing and continuing surveillance, which may be coupled with assessment of a suppliers quality system against the appropriate standards in the IS0 9000 series. iv STD-BSI BS EN IS0 Bhh7-2-ENGL 1777 W 1bZqbbS ObLbbLB 472 W EN IS0 8669-2 : 19

26、96 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);

27、b) urine collection bags intended to be used with a hanger or a floor stand (non-body-worn bags). - - a It does not apply to urostomy bags, urimeters and urine bags intended specifically for paediatric use. - - - 2 Normative reference rc * m The following standard contains provisions which, through

28、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 rece

29、nt edition of the standard indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 8669-1 :1988, Urine collection bags - Part I: Vocabulary. 3 Definitions For the purposes of this pari of IS0 8669, the definitions given in IS0 8669-1 and the followi

30、ng 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 con?ents. 3.3 rated volume: Capacit

31、y 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 stcength and leakage resistance of the bag assembly (see 6.1). 1 - STD

32、-BSI BS EN IS0 Bbb7-2-ENGL 1777 Lb24bb Ob1bbL 329 EN IS0 8669-2 : 1996 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 sh

33、all 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

34、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

35、 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 pari of the integral suspensory system shall fail to support the bag. 4.

36、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 Pressurehime 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 w

37、ithin 1 min and the average filling rate shall be not less than 10 mus. 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 f 2 “C. 2 STD-BSI

38、BS EN IS0 Abby-2-ENGL 1777 Lb2qbb7 ObLbb20 040 EN IS0 8669-2 1996 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 6.1.1 Principie The urine collection bag is filled with water and the volume of water within the bag is measu

39、red. 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 accuracy of f 2 Yo. 6.1.3.2 Filling system, of arrangement and dimensions shown in figure 1. To maintain a constant hydrostatic head, the rate of flo

40、w 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 - E rn 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

41、 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. * * NOTE - Most bags have a drainage tap through which air can be squeezed out. 6.1.4.3 Measure the distance between bo

42、ttom and top of the bag (l4 in figure A.l) and mark a horizontal line at 0,75 14, measuring from the bottom of the bag. 6.1.4.4 Suspend a non-body-worn bag using the manufacturers recommended suspension system. Suspend a body-worn bag freely in a vertical position, so that the volume of the bag is n

43、ot 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 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

44、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 14 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.

45、 If leakage has occurred, deem the test inuslid and rcpcat it, iising a fresh bag if wxssry. 6.1.4.10 Clamp tne 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). Measur

46、e the volume, in millilitres, 2nd rocw! i? z-. ths te?! re c ar =CL%C:J 3f C 2 ?C. 3 STD*BSI BS EN IS0 BbbY-Z-ENGL 1777 Lb24bb9 ObLbbZL T87 EN IS0 8669-2 : 1996 6.1.5 Test report The test report shall contain the general information specified in clause 7, together with the test volume. Dimensions in

47、 millimetres 0 dhside diameter) Water inflow - Reservoir with baffles to eliminate vortex I -EEL-I 1 Fl Connecting tubing II U t C C U u Reservoir ,- Urine collection bag NOTE - d 3 largest internal diameter of inlet tubing of bag. Figure 1 - Filling system for determination of test volume 6.2 Freed

48、om 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 water, comprising tap wat

49、er coloured by the addition of 0,3 g/l of erythrosin (E 127). 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. 4 STD-BSI BS EN IS0 Bbbq-Z-ENGL 1777 = 1b24bbS ObLbb22 913 EN IS0 8669-2 : 1996 150 i2 I 10 Dimensions in millimetres Plan view of reservoir showing vertical dividers to ellminate vortex Dimensions sufficient for reservoir to contain Liquid volume equ