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1、INTERNATIONAL STANDARD ISO 1135-4 Third edition 2004-07-15 Reference number ISO 1135-4:2004(E) ISO 2004 Transfusion equipment for medical use Part 4: Transfusion sets for single use Matriel de transfusion usage mdical Partie 4: Appareils de transfusion non rutilisables ISO 1135-4:2004(E) ii ISO 2004
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5、s given below. ISO 2004 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs m
6、ember body in the country of the requester. 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.org Web www.iso.org Published in Switzerland ISO 1135-4:2004(E) ISO 2004 All rights reserved iii Contents Page 1Scope 1 2Normative refer
7、ences 1 3General requirements 1 3.1Nomenclature for components of the transfusion set . 1 3.2Maintenance of sterility 3 3.3Designation 3 4Materials . 4 5Physical requirements . 4 5.1Particulate contamination 4 5.2Leakage 4 5.3Tensile strength . 4 5.4Closure-piercing device 4 5.5Air-inlet device . 5
8、5.6Tubing . 5 5.7Filter for blood and blood components . 5 5.8Drip chamber and drip tube . 5 5.9Flow regulator 5 5.10Flow rate of blood and blood components . 5 5.11Injection site 6 5.12Male conical fitting 6 5.13Protective caps 6 6Chemical requirements . 6 6.1Reducing (oxidizable) matter . 6 6.2Met
9、al ions . 6 6.3Titration acidity or alkalinity . 6 6.4Residue on evaporation 6 6.5UV absorption of extract solution 6 7Biological requirements 7 7.1General . 7 7.2Sterility . 7 7.3Pyrogenicity . 7 7.4Haemolysis 7 7.5Toxicity . 7 8Labelling . 7 8.1Unit container 7 8.2Shelf or multi-unit container . 8
10、 9Packaging . 8 Annex A (normative) Physical tests . 9 Annex B (normative) Chemical tests 13 ISO 1135-4:2004(E) iv ISO 2004 All rights reserved Annex C (normative) Biological tests . 15 Bibliography . 16 ISO 1135-4:2004(E) ISO 2004 All rights reserved v Foreword ISO (the International Organization f
11、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
12、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
13、ional Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The 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
14、 as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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.
15、 ISO 1135-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This third edition cancels and replaces the second edition (ISO 1135-4:1998), which has been technically revised. ISO 1135 consists of the following parts, und
16、er the general title Transfusion equipment for medical use: Part 3: Blood-taking set Part 4: Transfusion sets for single use . vi INTERNATIONAL STANDARDISO 1135-4:2004(E) ISO 2004 All rights reserved 1 Transfusion equipment for medical use Part 4: Transfusion sets for single use 1Scope This part of
17、ISO 1135 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. This part of ISO 1135 also specifies requirements for air-inlet devices for use with rigid cont
18、ainers for blood and blood components. Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacop
19、oeia or other national regulations are legally binding and take precedence over this part of ISO 1135. 2Normative 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 la
20、test edition of the referenced document (including any amendments) applies. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and
21、 certain other medical equipment Part 2: Lock fittings ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 7864:1993, Sterile hypodermic needles for single use ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanlin
22、ess ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 3General requirements 3.1Nomenclature for components of the transfusion set The nomenclature for components of transfusion sets is given in Figure 1. An air-inlet device as shown in
23、 Figure 2 is required for use with rigid containers for blood and blood components. ISO 1135-4:2004(E) 2 ISO 2004 All rights reserved Key 1protective cap of the closure-piercing device 2closure-piercing device 3fluid channel 4drip tube 5drip chamber 6filter for blood and blood components 7tubing 8fl
24、ow regulator 9injection site 10male conical fitting 11protective cap of the male conical fitting a Indicates alternative locations of the filter for blood and blood components. Other designs are acceptable if the same safety aspects are ensured. b Injection site is optional. Figure 1 Example of a tr
25、ansfusion set ISO 1135-4:2004(E) ISO 2004 All rights reserved 3 NOTEFigure 1 illustrates an example of a transfusion set. Figure 2 illustrates a separate air-inlet device. Figures 1 and 2 do not form part of the requirements for transfusion sets for single use as specified in this part of ISO 1135.
26、3.2Maintenance of sterility The transfusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle. 3.3Designation 3.3.1Transfusio
27、n set An example of the designation of a transfusion set complying with the requirements of this part of ISO 1135 is as follows: Transfusion set ISO 1135-4 TS 3.3.2Air-inlet device An example of the designation of an air-inlet device complying with the requirements of this part of ISO 1135 is as fol
28、lows: Air-inlet device ISO 1135-4 AD Key 1protective cap 2closure-piercing device or needle 3tubing 4clamp 5air-inlet with air filter a Other designs are acceptable if the same safety aspects are ensured. Figure 2 Example of an air-inlet device ISO 1135-4:2004(E) 4 ISO 2004 All rights reserved 4Mate
29、rials The materials from which the transfusion set and its air-inlet device as given in Clause 3 are manufactured shall comply with the requirements specified in Clause 5. If components of the transfusion set come into contact with blood and blood components, they shall additionally comply with the
30、requirements specified in Clauses 6 and 7. 5Physical requirements 5.1Particulate contamination The transfusion sets shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the
31、number of particles detected shall not exceed the contamination index. 5.2Leakage The transfusion set, when tested in accordance with A.2, shall show no signs of air leakage. 5.3Tensile strength Any connections between the components of the transfusion set, excluding protective caps, shall withstand
32、 a static tensile force of not less than for . 5.4Closure-piercing device 5.4.1The dimensions of the closure-piercing device shall conform with the dimensions shown in Figure 3. NOTEThe dimension of in Figure 3 is a reference measurement. The cross-section of the piercing device at this site is a ci
33、rcle. 5.4.2The closure-piercing device, and the air-inlet device if used, shall be capable of piercing and penetrating the closure of a container for blood and blood components without pre-piercing. No coring should occur during this procedure. 5.5Air-inlet device 5.5.1The air-inlet device shall als
34、o conform with 3.3 and 7.2. Dimensions in millimetres Figure 3 Dimensions of the closure-piercing device 15 N15 s 15 mm ISO 1135-4:2004(E) ISO 2004 All rights reserved 5 5.5.2The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container into wh
35、ich the device is to be inserted. 5.5.3The air-inlet device shall be separate from the closure-piercing device. 5.5.4If the end of the air-inlet device is connected to an air filter by means of flexible tubing, the tubing shall be not less than in length. 5.5.5The air filter shall be fitted in such
36、a manner that all air entering the rigid container passes through it and that the flow of fluid is not reduced by more than of that from a freely ventilated container when tested in accordance with A.3. 5.6Tubing 5.6.1The tubing, made of flexible material, shall be transparent or sufficiently transl
37、ucent so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected-to-normal vision. 5.6.2The tubing from the distal end to the drip chamber shall be not less than in length, including the injection site, when provided, and the male conical fittin
38、g. 5.7Filter for blood and blood components The transfusion set shall be provided with a filter for blood and blood components. The filter shall have uniform pores and shall cover a total area of not less than . When tested in accordance with Annex A, A.4, the mass of solid material retained on the
39、filter shall be not less than (mass fraction) of that retained on the reference filter. 5.8Drip chamber and drip tube The drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the drip chamber through a tube which projects into the chamber. There shall be a di
40、stance of not less than between the end of the drip tube and the outlet of the chamber, or a distance of not less than between the drip tube and the filter for blood and blood components. The wall of the drip chamber shall not be closer than to the end of the drip tube. The drip tube shall be such t
41、hat 20 drops of distilled water at and at a flow rate of () drops/min deliver . The drip chamber should permit and facilitate the procedure of priming. 5.9Flow regulator The flow regulator shall adjust the flow of the blood and blood components between zero and maximum. The flow regulator should be
42、capable of continuous use throughout a transfusion without the tubing being damaged. There should be no deleterious reaction between the flow regulator and the tubing when stored in such a manner that there is contact. 5.10Flow rate of blood and blood components The transfusion set shall deliver not
43、 less than of blood at in with a pressure difference of . The transfusion set shall also deliver not less than of blood in under a pressure of above atmospheric pressure. The blood shall be collected into a suitable anticoagulant solution and stored for not less than 2 weeks, and be free of large cl
44、ots. 250 mm 20 % 1 500 mm 10 cm2 80 % 40 mm 20 mm 5 mm(232) C 5010(10,1) ml (10,1) g 1 000 ml(232) C 30 min 10 kPa500 ml2 min 30 kPa ISO 1135-4:2004(E) 6 ISO 2004 All rights reserved 5.11Injection site When provided, the self-sealing injection site shall reseal when tested in accordance with A.5, an
45、d there shall be no leakage of more than one falling drop of water. The injection site should be located near the male conical fitting. 5.12Male conical fitting The distal end of the tubing shall terminate in a male conical fitting conforming with ISO 594-1 or ISO 594-2. Luer lock fittings in accord
46、ance with ISO 594-2 should be used. 5.13Protective caps The protective caps at the end of the transfusion set shall maintain the sterility of the closure-piercing device, the male conical fitting and the interior of the transfusion set. Protective caps should be secure but easily removable. 6Chemica
47、l requirements 6.1Reducing (oxidizable) matter When tested in accordance with B.2, the total amount of potassium permanganate solution, , used shall not exceed . 6.2Metal ions The extract shall not contain in total more than of barium, chromium, copper, lead and tin, and not more than of cadmium, wh
48、en determined by atomic absorption spectroscopy (AAS) or an equivalent method. When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not exceed that of the standard matching solution containing . 6.3Titration acidity or alkalinity When tested in accordan
49、ce with B.4, not more than of either standard volumetric solution shall be required for the indicator to change to the colour grey. 6.4Residue on evaporation When tested in accordance with B.5, the total amount of dry residue shall not exceed . 6.5UV absorption of extract solution When tested in accordance with B.6, the extract solution S1 shall not show absorption greater than 0,1. c(KMnO4)=0,002 mol/l2,0 ml 1g/ml 0,1g/ml (Pb2+)=1g/ml 1 ml 5 mg ISO 1135-4:2004(E) ISO 2004 All rights
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