BS EN ISO 8670-2-1997 Ostomy collection bags Requirements and test methods《造口术收集袋 试验方法和要求》.pdf

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1、BRITISH STANDARD BS EN ISO 8670-2:1997 Ostomy collection bags Part 2: Requirements and test methods The European Standard EN ISO 8670-2:1996 has the status of a British Standard ICS 11.140; 11.180BSEN ISO 8670-2:1997 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 94/508294 DC ISBN 0 580 27420 9 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 CommentsBSEN ISO 8670-2:1997 BSI 02-1999 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Text of EN ISO 8670-2 1BSEN ISO 86

6、70-2:1997 ii BSI 02-1999 National foreword This British Standard has been prepared by Technical Committee CH/47, and is the English language version of ENISO8670-2:1996 Ostomy collection bags Part 2: Requirements and test methods, published by the European Committee for Standardization (CEN). It sup

7、ersedes BS7127-101:1992 which is withdrawn.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 obligation

8、s. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, theEN title page, page 2, the ISO title page, pages ii to iv, pages 1 to 6 andabackcover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indic

9、ated in the amendment table on theinside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8670-2 December 1996 ICS 11.180 Descriptors: See ISO document English version Ostomy collection bags Part 2: Requirements and test methods (ISO8670-2:1996) Poches de recueil pour stomie Part

10、ie2:Prescriptions et mthodes dessai (ISO 8670-2:1996) Ostomiesammelbeutel Teil 2: Anforderungen und Prfverfahren (ISO8670-2:1996) This European Standard was approved by CEN on1996-12-14. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givi

11、ng 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 versio

12、ns (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, De

13、nmark, 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 Central Secretariat: rue de Stassart 36

14、, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN ISO 8670-2:1996 EENISO 8670-2:1996 BSI 02-1999 2 Foreword The text of the International Standard ISO8670-2:1996 has been prepared by Technical CommitteeISO/TC 173 “Technical systems and aids for disabled or handicapped persons” in

15、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, at the latest by June1997, and confl

16、icting national standards shall be withdrawn at the latest by June1997. 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, Icela

17、nd, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO8670-2:1996 was approved by CEN as a European Standard without any modification.EN ISO8670-2:1996 ii BSI 02-1999 Contents Pag

18、e Foreword ii Introduction 1 1 Scope 1 2 Normative reference 1 3 Definitions 1 4 Requirements 1 5 General test conditions 1 6 Test methods 1 7 Test reports 6 Figure 1 Set-up for measuring test volume 2 Figure 2 Set-up for testing for flange leakage 4 Descriptors: Disabled persons, medical equipment,

19、 ostomy collection bags, specifications, performance, tests, test equipment.EN ISO8670-2:1996 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

20、 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

21、 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 Standa

22、rd requires approval by at least75% of the member bodies casting a vote. International Standard ISO8670-2 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

23、 replaces the first edition (ISO 8670-2:1991) which has been technically revised. ISO 8670 consists of the following parts, under the general title Ostomy collections bags: Part 1: Vocabulary; Part 2: Requirements and test methods.iv blankEN ISO 8670-2:1996 BSI 02-1999 1 Introduction Users of this p

24、art of ISO 8670 are advised to consider the desirability of third-party certification of product conformity with this part of ISO8670, based on testing and continuing surveillance, which may be coupled with assessment of a suppliers quality system against the appropriate standards in the ISO9000 ser

25、ies. 1 Scope 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 prov

26、isions which, through reference in this text, constitute provisions of this part of ISO8670. 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 ISO8670 are encouraged to investigate the possibility of ap

27、plying 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 Part1:Vocabulary. 3 Definitions For the purposes of this part of ISO 8670, the definitions given in ISO8670-1

28、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 at

29、tached 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

30、 an ostomy collection bag when performing tests to verify the strength and leakage resistance of the bag assembly 4 Requirements 4.1 Freedom from leakage 4.1.1 When tested by the method given in6.2, bags without flanges shall not leak. 4.1.2 When tested by the method given in6.3, bags (systems) with

31、 flanges shall not leak. 4.2 Retention of open-ended bag closure When tested by the method given in6.4, the open-ended bag closure shall remain in position when used following the bag manufacturers instructions. 4.3 Burst strength (static) When tested by the method given in6.5, the bag shall not lea

32、k. 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

33、) 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 23C 2C. 5.2 Test samples Testing shall be carried out on product samples as supplied to the end-user. 6 Test methods 6.1 Test volu

34、me 6.1.1 Principle The ostomy collection bag is filled with water and the volume of water within the bag is measured.ENISO 8670-2:1996 2 BSI 02-1999 6.1.2 Reagent 6.1.2.1 Tap water 6.1.3 Apparatus 6.1.3.1 Rigid transparent plate (seeFigure 1), of sufficient size to support the whole of the bag in th

35、e horizontal position, having a hole of diameter10mm 0,2mm 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 mea

36、surement accuracy of 2 %. 6.1.4 Procedure 6.1.4.1 For open-ended bags with a bottom opening, close the outlet 30mm 5mm from the bottom by welding or by repeated folding secured with a binder clip or other securing device not exceeding100g in mass. For open-ended bags with a top opening, close the op

37、ening in accordance with the manufacturers instructions. Do not use a rubber band for closure purposes. 6.1.4.2 If there is no precut opening in the ostomy bag assembly, or if the opening is of diameter less than15mm, cut a central hole of diameter15mmmm. +2 0 Figure 1 Set-up for measuring test volu

38、meEN ISO 8670-2:1996 BSI 02-1999 3 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. 6.1.4.4 Remove

39、as much air as possible from the ostomy bag under test. In the case of urostomy bags, this may 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 closed position. 6.1.4.5 Open

40、 the water supply tap (6.1.2.1) and allow water to enter the bag, ensuring that no air is entrained, until the level of water in the bag reaches the bottom of the hole in the test plate. Turn off the tap. 6.1.4.6 Remove the filling connector from the test plate and allow the level of water in the ba

41、g to stabilize for1mins. 6.1.4.7 If necessary, remove or add water to the bag using the filling connector until the water in the bag is level with the bottom of the hole in the test plate when filling connector is removed. NOTEIn the case of urostomy bags, two water levels may be observed, one on ea

42、ch side of the nonreturn valve. In this case, the upper water level at the flange opening is used to establish the test volume. 6.1.4.8 Empty the water from the bag into a graduated cylinder (6.1.3.3). Measure the volume, in millilitres, and record it as the test volume of the bag. 6.1.5 Test report

43、 The test report shall contain the general information specified in clause7, together with the test volume. 6.2 Freedom from leakage of bags without flanges 6.2.1 Principle The ostomy collection bag is filled with coloured water, positioned horizontally and examined for leakage. It is then suspended

44、 vertically and again examined visually for leakage. This method does not test for: a) leakage from vents, filters, vent and filter plugs and the interface between the test surface and the bag assembly; b) leakage from the open-ended bag closure. 6.2.2 Reagent 6.2.2.1 Coloured water, comprising tap

45、water coloured by the addition of0,3g/l of erythrosin (E127). 6.2.3 Apparatus 6.2.3.1 Rigid, transparent test plate, as specified in6.1.3.1. 6.2.3.2 Means of sealing all openings not to be tested. 6.2.3.3 Absorbent material, white. 6.2.4 Procedure 6.2.4.1 Seal all openings (see6.2.3.2), such as vent

46、s, filters and openings of open-ended bags, and attach the bag to the test plate (6.1.3.1). If there is no precut opening for the stoma, cut a hole as described in6.1.4.2. Attach the bag to the test plate as described in6.1.4.3. 6.2.4.2 If the bag is a urostomy bag fitted with a drainage tap, pour a

47、 small amount of coloured water(6.2.2.1) into the bag and open and close the tap ten times, ensuring that the coloured water is present in the bag during the whole operation. 6.2.4.3 Position the bag/test plate assembly vertically and fill the bag through the filling port with75% of the test volume

48、(see6.1.4.8) using the coloured water, ensuring that air is not entrained. 6.2.4.4 Visually inspect the bag for leakage after1mins. If leakage is observed, discontinue the test. 6.2.4.5 Close the inlet hole and dry the surface of bag assembly. Position the bag/test plate assembly horizontally beneat

49、h the bag with the absorbent material (6.2.3.3) between the bag and test plate. Leave undisturbed for17h 1h and then visually inspect the bag and absorbent material for signs of leakage. Discontinue the test if leakage has occurred. 6.2.4.6 Reposition the same bag/test plate assembly in a vertical position with absorbent material beneath it. Leave undisturbed for4h 1h, then visually inspect for signs of leakage. 6.2.5 Test report The test report shall contain the general information specified inclause7, together with a statemen