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1、 Reference number ISO 15137:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 15137 First edition 2005-07-15 Self-adhesive hanging devices for infusion bottles and injection vials Requirements and test methods Systmes de suspension autoadhsifs pour flacons de perfusion Exigences et mthodes dessai Copyrigh
2、t International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) PDF disclaimer This PDF file may contain embedded type
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5、mized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2005 All rights reserved. Unless otherwise specified, no
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7、le 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for
8、Resale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) ISO 2005 All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The w
9、ork 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 the right to be represented on that committee. International organizations, governmental and non-govern
10、mental, 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The
11、 main task of technical committees is to prepare International Standards. 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.
12、 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15137 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipme
13、nt for medical and pharmaceutical use. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) iv ISO
14、2005 All rights reserved Introduction Self-adhesive hanging devices have become a common method for hanging infusion containers. The application is easy because no further equipment is needed. The intended purpose of self-adhesive hanging devices is to provide a simple and safe hanging of infusion c
15、ontainers during the administration of liquid pharmaceutical products. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS
16、 -,-,- INTERNATIONAL STANDARD ISO 15137:2005(E) ISO 2005 All rights reserved 1 Self-adhesive hanging devices for infusion bottles and injection vials Requirements and test methods 1 Scope This International Standard specifies requirements and test methods for self-adhesive hanging devices (SAHD) use
17、d in combination with infusion containers, e.g. infusion glass bottles (see ISO 8536-1). The purpose of this International Standard is to establish a safe SAHD for prescribed infusion containers while administering their content so as to ensure a safe application for the patient and for the user. 2
18、Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 2768-1:1989, General tol
19、erances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 self-adhesive hanging device SAHD self-adhesive label consisting of an adhesive portion and
20、a hanging portion 4 Designation SAHDs in accordance with the requirements of this International Standard are designated as follows: Self-adhesive hanging device ISO 15137 This should be marked on the label. 5 Materials Materials selected for the SAHD shall ensure that all requirements specified in C
21、lause 6 are met. Some materials could be damaged by some influences such as disinfection fluids or UV-light. This should be considered when choosing a suitable material. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not
22、for Resale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) 2 ISO 2005 All rights reserved 6 Requirements 6.1 Surface condition of the infusion container The surface of the infusion container shall be clean, dry, free of dust and grease
23、 or any kind of release agents, e.g. agents containing silicone or wax. NOTE Any treatment of the surface of the infusion container can have a negative impact on the adhesion force between the SAHD and the infusion container. 6.2 Label attachment At least 95 % of the adhering part of the SAHD shall
24、be in direct contact with the surface of the infusion container. Care should be taken to avoid wrinkles, bubbles and uneven surfaces on the infusion containers. 6.3 Load resistance 6.3.1 Permanent load The SAHD shall not break and shall not detach from the infusion container when tested according to
25、 7.4.1. 6.3.2 Short term load The SAHD shall not break and shall not detach from the infusion container when tested according to 7.4.2. 6.3.3 Gravitational load The SAHD shall not break and shall not detach from the infusion container when tested according to 7.4.3. 6.4 Elongation The distance betwe
26、en the hook and the infusion container shall not increase by more than 50 % when tested in accordance with 7.5 (see Figure 4). 6.5 Resistance in water bath When testing in accordance with 7.6, the requirements specified in 6.3.1, 6.3.2 and 6.4 shall be met. 6.6 Adherence to vertical position The han
27、ging portion of the SAHD shall be designed in such a way that the infusion container shall not deviate from a vertical position by more than 10 (see Figure 3). 6.7 Long term performance After having been attached to the infusion container and having been stored suitably (no UV-light, storage tempera
28、ture between 10 C and 30 C), the SAHD shall comply with the requirements of this International Standard for 6 years or until the expiration date of the product. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resal
29、e, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) ISO 2005 All rights reserved 3 7 Tests 7.1 General 7.1.1 Figure 1 illustrates a SAHD. With the adhesive portion, the SAHD is attached to a suitable container (see Figure 2). The hanging
30、 portion allows the infusion container to be hung on a hook (see Figures 3 and 5). In order to administer the content, the container is hung on a hook with its neck facing downwards (see Figure 3). Nevertheless, when testing, it is possible to change this orientation in order to simplify the test pr
31、ocedure (see Figures 3 and 4). Key 1 hanging portion 2 adhesive portion Figure 1 Example of a SAHD Figure 2 Example of a SAHD attached to an infusion container Key 1 hanging portion 2 adhesive portion 3 hook Figure 3 Example of an infusion container with attached SAHD Copyright International Organiz
32、ation for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) 4 ISO 2005 All rights reserved Key 1 test hook 2 test weight piece (from 3 kg
33、 to 6 kg) F test load a The distance from infusion container to test hook (shall not increase by more than 50 %). Figure 4 Example of an infusion container with attached SAHD during test procedure 7.1.2 All tests shall be performed at a temperature of (23 3) C and a relative humidity of (50 10) %. 7
34、.2 Label attachment 7.2.1 Make sure that the infusion containers used for the test correspond to 6.1. 7.2.2 Properly attach the SAHD under test to the infusion container. Check visually if the contact area between the adhesive portion of the SAHD and the infusion container corresponds to 6.2. 7.2.3
35、After applying the SAHD to the infusion container, allow the label adhesive to cure according to the manufacturers specification see 10 a) before starting the tests. 7.3 Test weight pieces Test weight pieces used for the load tests are specified in Table 1. Table 1 Test weight pieces Nominal volume
36、ml Test weight pieces kg Permanent load 24 h Short term load 30 s Fall-test made with 250 3 6 filled infusion container 250 to 1 000 5 6 filled infusion container Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Res
37、ale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) ISO 2005 All rights reserved 5 7.4 Load tests 7.4.1 Permanent load test Take an infusion container with an attached SAHD. Select the appropriate test weight piece from Table 1 and con
38、nect the test weight piece with a test hook given in Figure 5. Connect the hanging portion of the SAHD with the test weight piece using the test hook as indicated in Figure 4. Apply the test load for 24 h. The apparatus under test passes the test if the requirements specified in 6.3.1 are fulfilled
39、for at least 24 h. 7.4.2 Short term load test Take an infusion container with an attached SAHD. Select the appropriate test weight piece from Table 1 and connect the test weight piece with a test hook given in Figure 5. Connect the hanging portion of the SAHD with the test weight piece using the tes
40、t hook as indicated in Figure 4. Apply the test load for 30 s. The apparatus under test passes the test if the requirements specified in 6.3.2 are fulfilled for at least 30 s. 7.4.3 Gravitational test Take a filled infusion container with an attached SAHD. Connect one end of a stable cord to the han
41、ging portion of the SAHD and connect the other end of the cord to a fixed bracket in such a way that the container can hang and swing freely without interference. Lift the container to a height of 30 cm above its resting position and let it fall freely. The apparatus under test passes the test if th
42、e requirements specified in 6.3.3 are fulfilled. 7.5 Elongation test The distance from the test hook to the infusion container is measured at the beginning and at the end of the permanent load test in accordance with 7.4.1. The apparatus under test passes the test if the requirements specified in 6.
43、4 are fulfilled. Dimensions in millimetres General tolerances according to ISO 2768-m (see ISO 2768-1:1989). Figure 5 Test hook 7.6 Water resistance test Place a filled infusion container with an attached SAHD into a water bath for 24 h at a water temperature of (40 3) C. Ensure that the SAHD is tot
44、ally immersed in the water for the duration of the test. Remove the infusion container from the water bath and wait for 5 min. Then perform the test according to 7.4.1. The apparatus under test passes the test if the requirements specified in 6.5 are fulfilled. Copyright International Organization f
45、or Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:23:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) 6 ISO 2005 All rights reserved 8 Packaging The SAHD shall be packaged in such a way
46、that it maintains its functionality and cleanliness during transportation and storage. 9 Storage The SAHD shall have a shelf life of at least 2 years before being attached to the infusion container when stored according to the storage conditions given by the manufacturer. 10 Information to be provid
47、ed by the manufacturer The manufacturer shall provide the following information: a) curing time; b) shelf life; c) storage conditions. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007 02:23:18 MDT
48、No reproduction or networking permitted without license from IHS -,-,- ISO 15137:2005(E) ISO 2005 All rights reserved 7 Bibliography 1 ISO 8536-1, Infusion equipment for medical use Part 1: Infusion glass bottles Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Aramco HQ/9980755100 Not for Resale, 04/23/2007