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1、 Reference number ISO 16391:2002(E) ISO 2002 INTERNATIONAL STANDARD ISO 16391 First edition 2002-10-01 Aids for ostomy and incontinence Irrigation sets Requirements and test methods Aides pour ostomie et incontinence Dispositifs dirrigation Exigences et mthodes dessai ISO 16391:2002(E) PDF disclaime
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6、equester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2002 All rights reserved ISO 16391:2002(E) ISO 2002 All rights reserved iii Foreword ISO (the International Organization f
7、or 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 th
8、e 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. Internat
9、ional Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. 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 membe
10、r bodies casting a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 16391 was prepared by Technical Com
11、mittee ISO/TC 173, Technical systems and aids for disabled or handicapped persons, Subcommittee SC 3, Aids for ostomy and incontinence. -,-,- INTERNATIONAL STANDARD ISO 16391:2002(E) ISO 2002 All rights reserved 1 Aids for ostomy and incontinence Irrigation sets Requirements and test methods 1 Scope
12、 This International Standard specifies performance requirements and test methods for irrigation sets, used in colostomy care. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For d
13、ated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For u
14、ndated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 8670-2, Ostomy collection bags Part 2: Requirements and test methods ISO 10993-1, Biological evaluation of medical devices Pa
15、rt 1: Evaluation and testing 3 Terms and definitions For the purposes of this International Standard, the following terms and definitions apply. Certain of these terms are illustrated in Figure 1. 3.1 belt band of flexible material worn around the waist and secured to the pressure plate of drainage
16、sleeve 3.2 colostomy surgical opening, or stoma, created between the colon and surface of the body 3.3 connector device that joins components of the irrigation set 3.4 drainage system assembly of parts used to drain the colostomy, consisting of drainage sleeve, pressure plate, stoma hole, hook and b
17、elt 3.5 drainage sleeve conduit to pass stomal effluent from the colostomy to a waste disposal container -,-,- ISO 16391:2002(E) 2 ISO 2002 All rights reserved 3.6 flow controller device that adjusts the flow rate of irrigation water NOTE A flow controller is adjustable from the closed position to t
18、he fully opened position. 3.7 flow indicator device that indicates the flow rate of the irrigation water 3.8 inflow system assembly of parts used to introduce water into the colostomy, consisting of stoma adapter, connector, flow controller, flow indicator, tube, irrigation water bag, volume indicat
19、or, suspension and hanger 3.9 irrigation introduction of water into the colon to be washed and discharged from faeces 3.10 irrigation set assembly of all parts that are used during colostomy irrigation, consisting of inflow system and drainage system 3.11 irrigation water bag bag that holds water fo
20、r irrigation 3.12 pressure plate device that secures the drainage sleeve on the abdomen and around the colostomy 3.13 stoma abnormal opening established on the body surface ISO 8670-2 3.14 stoma adapter terminal part to be inserted into the stoma when irrigation water is transferred into the colon 3
21、.15 test volume volume of water that is added up to the maximum scale line indicated in the irrigation water bag when performing tests to verify the leakage and strength of the bag assembly 3.16 tube conduit which connects the irrigation water bag and the stoma adapter 3.17 volume indicator scale li
22、nes that indicate approximate volume in the irrigation water bag -,-,- ISO 16391:2002(E) ISO 2002 All rights reserved 3 Dimensions in millimetres Key 1 Tube 6 Belt 11 Stoma hole 2 Hanger 7 Flow indicator 12 Pressure plate 3 Suspension 8 Flow controller 13 Hook 4 Irrigation water bag 9 Connector 14 D
23、rainage sleeve 5 Volume indicator 10 Stoma adapter Figure 1 Irrigation set Inflow system (left) and drainage system (right) ISO 16391:2002(E) 4 ISO 2002 All rights reserved 4 Requirements 4.1 Accuracy of the volume indicator When tested by the method given in 6.1, the difference in volume between an
24、y two lines of the volume indicator (3.17) shall not deviate from the actual measured difference by more than 15 % of the actual volume difference. The difference between the maximum indicated volume and the actual test volume (3.15) shall be less than 15 %. 4.2 Freedom from leakage When tested by t
25、he method given in 6.2, the inflow system (3.8) of the irrigation set (3.10) shall not leak. 4.3 Flow controller When tested by the method given in 6.3, the flow rate shall be not less than 200 ml/min. 4.4 Hanging strength of the irrigation water bag and its suspension system When tested by the meth
26、od given in 6.4, the irrigation water bag (3.11) and/or suspension shall not break. 4.5 Hanging strength of the belt hook and the pressure plate interface When tested by the method given in 6.5, the belt (3.1) and/or pressure plate (3.12) shall not break. 4.6 Biological evaluation When tested in acc
27、ordance with ISO 10993-1, the irrigation set (3.10) shall be free from biological hazards. 5 General test conditions 5.1 Temperature The standard testing temperature shall be (23 2) C. Condition the test specimens at this temperature for at least 1 h before testing. The temperature of the coloured a
28、nd uncoloured water reagent shall be (37 2) C when added, and at least 32 C at the end of the test. 5.2 Reagent 5.2.1 Coloured water, comprising tap water coloured by the addition of 0,3 g/l of erythrosin (E127). 5.3 Test samples Testing shall be carried out on product samples as supplied by the man
29、ufacturer to the end-user. ISO 16391:2002(E) ISO 2002 All rights reserved 5 6 Test methods 6.1 Accuracy of the volume indicator 6.1.1 Principle The irrigation water bag (3.11) is mounted vertically and filled with water to the line of the rated capacity. The volume of water accommodated by the bag i
30、s measured. 6.1.2 Apparatus 6.1.2.1 Two measuring cylinders, one of capacity 500 ml and one of minimum capacity 2 000 ml. 6.1.3 Procedure With the flow controller (3.6) completely closed, fill the irrigation water bag (3.11) with water to the test volume line, and position the inflow system (3.8) of
31、 the irrigation set (3.10) in accordance with the manufacturers instruction for use. Measure the volume between every line of the volume indicator (3.17) using the 500 ml cylinder (6.1.2.1), and transfer the content of the cylinder into the 2 000 ml cylinder (6.1.2.1) between each measurement. When
32、the water bag is empty, read the total volume on the 2 000 ml cylinder. 6.1.4 Test report The test report shall contain the general information specified in clause 7, together with the volumes measured between lines and the maximum volume. 6.2 Freedom from leakage 6.2.1 Principle Coloured water is a
33、dded to the inflow system (3.8) of the irrigation set (3.10), which is maintained in a vertical position. The irrigation set is examined for leakage. 6.2.2 Procedure Position the inflow system (3.8) vertically with the stoma adapter (3.14) plugged and the flow controller (3.6) fully open. Fill the b
34、ag through the filling port with coloured water (5.2.1) with the total test volume determined in 6.1. Ensure that air is not incorporated. Visually inspect the inflow system for leakage after 30 min. If leakage is observed, discontinue the test. Close the flow controller completely. Unplug the stoma
35、 adapter. Visually inspect the inflow system for leakage after 30 min. If leakage is observed, discontinue the test. 6.2.3 Test report The test report shall contain the general information specified in clause 7, together with a statement detailing where leakage was observed, if any. -,-,- ISO 16391:
36、2002(E) 6 ISO 2002 All rights reserved 6.3 Flow controller 6.3.1 Principle The volume of water that flows through the irrigation set at a determined height and time is measured. 6.3.2 Apparatus 6.3.2.1 Measuring cylinder, with a capacity above 500 ml. 6.3.2.2 Stopwatch, or similar timing device. 6.3
37、.3 Procedure Close the flow controller (3.6) in the irrigation set (3.10). Hang the irrigation water bag in vertical position and fill it to the total test volume determined in 6.1 with coloured water (5.2.1). Position the stoma adapter (3.14) so that its tip is (600 50) mm below the bottom of the i
38、rrigation water bag (3.11). Open the flow controller to the full position. Using the measuring cylinder (6.3.2.1), measure the amount of water discharged over a period of 1 min. 6.3.4 Test report The test report shall contain the general information specified in clause 7, together with the measured
39、flow rate (see 6.3.3) in litres per minute. 6.4 Hanging strength of the irrigation water bag and its suspension system 6.4.1 Principle The irrigation water bag is hung in accordance with the manufacturers instructions for use, and a force is applied to the bag in a downward direction. 6.4.2 Procedur
40、e Hang the irrigation water bag in a vertical position. Apply a force of 49 N to the lower end of the bag in a downward direction for 30 min. Examine the irrigation water bag for visible damage or breakage. If damage or breakage occurs, discontinue the test. An 8 mm diameter steel wire is recommende
41、d as hanger. NOTE The force applied is equivalent to a mass of 5 kg. 6.4.3 Test report The test report shall contain the general information specified in clause 7, together with a statement detailing where any visible damage or breakage was observed. -,-,- ISO 16391:2002(E) ISO 2002 All rights reser
42、ved 7 6.5 Hanging strength of the belt hook and the pressure plate interface 6.5.1 Principle The belt hook is connected to the plate interface and a force is applied for 30 min. The belt hook and pressure plate (3.12) are then inspected for visible damage or breakage. 6.5.2 Procedure Hook the belt (
43、3.1) to the pressure plate (3.12) and place it in a vertical position. Fix the plate, and attach a force of 49 N to the lower end of the belt in a downward direction for 30 min. NOTE The force applied is equivalent to a mass of 5 kg. Inspect the belt hook and vertical plate for visible damage or bre
44、akage. 6.5.3 Test report The test report shall contain the general information specified in clause 7, together with a statement detailing where any visible damage or breakage was observed. 6.6 Biological evaluation 6.6.1 Principle All parts of the inflow system (3.8) which come into contact with the
45、 irrigation water are tested with respect to biological hazards in accordance with the ISO 10993 series. 6.6.2 Selection and performance of tests Select the appropriate tests in accordance with ISO 10993-1. Carry out the selected tests, identified in ISO 10993-1. NOTE ISO 10993-1 identifies test met
46、hods for different features of the product/material. 6.6.3 Test report The test report shall contain the general information specified in clause 7, together with biological safety data of each part of the inflow system (3.8) of the irrigation set (3.10). 7 Test report The test report shall contain t
47、he following information: a) reference to this International Standard, i.e. ISO 16391; b) complete identification of the irrigation sets tested; c) date and place of testing; d) number of irrigation sets tested; e) test results as specified in 6.1.4, 6.2.3, 6.3.4, 6.4.3, 6.5.3 and 6.6.3. -,-,- ISO 16391:2002(E) ICS 11.180 Price based on 7 pages ISO 2001 All rights reserved -,-,-