EN ISO 8670-2-1996 en Ostomy Collection Bags - Part 2 Requirements and Test Methods《造口术收集袋 第2部分 要求和测试方法 ISO 8670-2-1996》.pdf

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1、 STD-BSI BS EN IS0 Bb70-2-ENGL 1997 Lb24bb9 Oblb59L 41T m BRITISH STANDARD Ostomy collection bags - Part 2. Requirements and test methods PIC Pxopeai Standard YN IS0 8670 3 : 1996 hz thr sta,tis cf c British Standard ICs 11.i4k 11.180 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGH

2、T LAW BS EN IS0 8670-2 : 1997 STD-BSI BS EN IS0 b70-2-ENGL 1997 m Lb2lbbS ObLb592 35b m Amd. No. BS EN IS0 8670-2 : 1997 Date Text affected Committees responsible for this British Standard The preparation of this British Standaxd was entrusted by Technical Committee CW47, Aids for ostomy and inconti

3、nence, 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 Ass

4、ociation 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 This British Standard, having been prepared und

5、er the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 May 1997 O BSI 1997 Amendments issued since publication The following BSI references relate to the work on this standard Committee reference CW47 Draft fo

6、r comment 94508294 DC I l ISBN O 680 27420 9 I l STD-BSI BS EN IS0 Bb70-2-ENGL 1997 W 1b24bb9 ObLb593 292 W BS EN IS0 8670-2 : 1997 National foreword This British Standard has been prepared by Technical Committee CW47, and is the English ianguage version of EN IS0 8670-2 : 1996 Ostomy collection bag

7、s - Part 2 : Requirements and test methods, published by the European Committee for Standardization (CEN). It supersedes BS 7127 : Part 101 : 1992 which is withdrawn. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This dccu ent conil;ri

8、ses a front cover. an inside front cover, pages i and ii, the EN title page arc! forewcrd, IS0 mver $age and pages ii to iv, pages 1 to 8, a blank inside back cover and a back cover. O BSI 1997 i EUROPEAN STANDARD NORME EUROPENNE EN IS0 8670-2 EUROPISCHE NORM December 1996 ICs 11.180 Descriptors: se

9、e IS0 document English version Ostomy collection bags - Part 2: Requirements and test methods (IS0 8670-2: 1 996) Poches de recueil pour stomie - Partie 2: !rez=riptims et mthodes dessai (IS0 8670-2:1996) Ostomiesamnelbeutel - Teil 2: Anforderungen und Prfverfahren (IS0 8670-2:1996) This European St

10、andard 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 su

11、ch national standards may be obtained on application to the Central Secretariat or to any CEN member. lhe 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

12、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 Unite

13、d Kingdom. CEN European Comnittee for Standardization Comit Europen de Normalisation Eurcpjsches Komitee fr Normung Central secretariat: rue de Stassart.36 8-1050 Brussels 0 1996 Copyright reserved to CEN menbe:$ Ref. No. EN IS0 8670-2:1996 E - STD-BSI BS EN IS0 b70-2-ENGL 1997 lb24bb7 ObLb595 Ob5 E

14、N IS0 8670-2 : 1996 Foreword The text of the International Standard IS0 8670-2:1996 has been prepared by Technical Committee ISO/TC I73 “Technical systems and aids for disabled or handicapped persons“ in collaboration with Technical Committee CEN/TC 293 “Technical aids for disabled persons“, the sec

15、retariat 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 CENK

16、ENELEC 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

17、the United Kingdom. Endorsement notice The text of the International Standard IS0 8670-2: 1996 was approved by CEN as a European Standard without any modification. STD-BSI BS EN IS0 8b70-2-ENGL 1777 H Lb2qbbS ObLb57b TT1 H EN IS0 8670-2 : 1996 INTERNATIONAL STANDARD IS0 8670-2 Second edition 1996-1

18、2-1 5 Ostomy collection bags - Part 2: Requirements and test methods Poches de recueil pour stomie - Partie 2: Prescriptions et mthodes dessai Reference nuinber IS0 8670-2:1996(E) EN IS0 8670-2 : 1996 Contents Page 1 Scope 1 2 Normative reference . 1 3 Definitions . 1 4 Requirements . 2 5 General te

19、st conditions . 2 6 Test methods 2 7 Test reports 8 Descriptors: disabled persons, medical equipment, ostomy collection bags, specifications, performance, tests, test equipment. i * rn * STD-BSI BS EN IS0 Bb70-2-ENGL L777 W LbZllbb7 ObLb5SB 874 = EN IS0 8670-2 : 1996 Foreword IS0 (the Intemational O

20、rganization 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 estab

21、lished 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. IS0 collaborates closely with the Intemational Electrotechnical Commission (IEC) on all matters of electrotechnical standardizati

22、on. 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 IS0 8670-2 was prepared by Technical Committee

23、 ISO/TC 173, 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 edition (IS0 8670-2:1991) which has been technically revised. IS0 8670 consists of the following parts, under the gener

24、al title Ostomy collections bags: - Part 7: Vocabulary - Part 2: Requirements and test methods iii EN IS0 8670-2 : 1996 Introduction Users of this part of IS0 8670 are advised to consider the desirability of third-party certification of product conformity with this part of IS0 8670, based on testing

25、 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 Bb70-2-ENGL 1997 Lb2qbbS ObLbb00 252 EN IS0 8670-2 : 1996 Ostomy collection bags - Part 2: Requirements and test methods 1 S

26、cope This part of IS0 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 contain- provisions

27、 which, through refer,.ice in this text, constitute provisions of this part of IB IS0 8670. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this patt of IS0 8670 are encouraged to investigate the possibility of ap

28、plying the most recent edition of the standard indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 8670-1 :1996, Ostomy collection bags - Part 1: Vocabulary. 3 Definitions For the purposes of this part of IS0 8670, the definitions given in IS0 8

29、670-1 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

30、 to be attached 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 3?brne: That dume or, wiiicli is basea trie vorume 0, iiquid added: or the

31、force applied, to an ostomy collection bag when performing tests to verify the strength and leakage resistance of the bag assembly. 1 STD*BSI BS EN IS0 Bb70-2-ENGL 1797 m Lb2LIbb9 ObLbbOL L77 m EN IS0 8670-2 : 1996 4 Requirements 4.1 Freedom from leakage 4.1.1 When tested by the method given in 6.2,

32、 bags without flanges shall not leak. 4.1.2 When tested by the method given in 6.3, bags (systems) with flanges shall not leak. 4.2 Retention of open-ended bag closure When tested by the method given in 6.4, the open-ended bag closure shall remain in position when used following the bag manufacturer

33、s instructions. 4.3 Burst strength (static) When tested by the method given in 6.5, the bag shall not leak. 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 suppl

34、ier. 4.4.2 If the opening for the stoma is intended to be enlarged, the maximum opening shall be either a) 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 23 OC f 2 OC. 5.2 Test sa

35、mples Testing shall be carried out on product samples as supplied to the end-user. 6 Test methods 6.1 Test volume 6.1.1 Principle The ostomy 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. 2 STD-BSI BS EN IS0 Bb70-2-ENGL 1997 L

36、bZqbbS ObLbbOZ 025 EN IS0 8670-2 : 1996 6.1.3 Apparatus 6.1.3.1 Rigid transparent plate (see figure l), of sufficient size to support the whole of the bag in the horizontal position, having a hole of diameter 10 mm f 0,2 mm to which a connector fitted with a tap can be secured. 6.1.3.2 Means of fill

37、ing 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 measurement accuracy of f 2 %. Dimensions in millimetres To water SUPPLY Transparent test plate Figure 1 - Set-up for measuring test volum

38、e 6.1.4 Procedure 6.1.4.1 For open-ended bags with a bottom opening, close the outlet 30 mm k 5 mm from the bottom by welding or by repeated folding secured with a binder clip or other securing device not exceeding 100 g in mass. For open- ended bags with a top opening, close the opening in accordan

39、ce with the manufacturers instructions. Do not use a rubber band for closure purposes. 3 STD-BSI BS EN IS0 Bb70-2-ENGL 1777 Lb2Ybb7 Ob1bb03 TbL EN IS0 8670-2 : 1996 6.1.4.2 If there is no precut opening in the ostomy bag assembly, or if the opening is of diameter less thai 15 mm, cut a central hole

40、of diameter 15 mm +: mm. 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 as much a

41、ir 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 the wate

42、r 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 bag to stab

43、ilize for 1 min+: s. 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. NOTE - In the case of urostomy bags, two water levels may be observed, one on eac

44、h side of the nonretum valve. In this case, the upper water level at the fiange 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 T

45、he test report shall contain the general information specified in clause 7, 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

46、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 w

47、ater coloured by the addition of 0,3 g/l of erythrosin (E 127). 6.2.3 Apparatus 6.2.3.1 Rigid, transparent test plate, as specified in 6.1.3.1. 6.2.3.2 Means of sealing all openings not to be tested. 6.2.3.3 Absorbent material, white. 4 STD.BSI BS EN IS0 b70-2-ENGL 1777 W Lb24bb7 ObLbb04 T8 EN IS0 8

48、670-2 : 1996 6.2.4 Procedure 6.2.4.1 Seal all openings (see 6.2.3.2), such as vents, 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 in 6.1.4.2. Attach the bag to the test plate as described

49、 in 6.1.4.3. 6.2.4.2 If the bag is a urostomy bag fitted with a drainage tap, pour a 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 baghest plate assembly vertically and fill the bag through the filling port with 75 % of the test volume (see 6.1.4.8) using the coloured water, ensuring that air is not entrained. 6.2.4.4 Visually inspect the bag for leakage after 1