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1、 Reference number ISO 8536-5:2004(E) ISO 2004 INTERNATIONAL STANDARD ISO 8536-5 Second edition 2004-02-01 Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravity feed Matriel de perfusion usage mdical Partie 5: Appareils non rutilisables de perfusion burette, aliment
2、ation par gravit ISO 8536-5:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the
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5、t at the address 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
6、below or ISOs member 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 ii ISO 2004 All rights reserved ISO 8536-5:2004(E) ISO 2004 All rights reser
7、ved 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 normally carried out through ISO technical committees. Each member body interested in a subject for w
8、hich 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 in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
9、 matters of electrotechnical standardization. International 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 c
10、irculated to the member bodies for voting. Publication 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 resp
11、onsible for identifying any or all such patent rights. ISO 8536-5 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical use. This second edition cancels and replaces the first edition (ISO 8536-5:1992), which has been technically revised. ISO 8536 c
12、onsists of the following parts, under the general title Infusion equipment for medical use: Part 1: Infusion glass bottles Part 2: Closures for infusion bottles Part 3: Aluminium caps for infusion bottles Part 4: Infusion sets for single use, gravity feed Part 5: Burette infusion sets for single use
13、, gravity feed Part 6: Freeze drying closures for infusion bottles Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusion sets for use with pressure infusion equipment Part 9: Fluid lines for use with pressure infusion equipment Part 10: Accessories for fluid line
14、s for use with pressure infusion equipment Part 11: Infusion filters for use with pressure infusion equipment -,-,- -,-,- INTERNATIONAL STANDARD ISO 8536-5:2004(E) ISO 2004 All rights reserved 1 Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravity feed 1 Scope Thi
15、s part of ISO 8536 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. This part of ISO 8536 also prov
16、ides guidance on specifications relating to the quality and performance of materials used in infusion sets. NOTE In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536. 2 Normative references The following referenced
17、 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 8536-4, Infusion equipment for medical use Part 4: Infusion sets for
18、single use, gravity feed 3 General requirements 3.1 The nomenclature to be used for components of burette infusion sets is given in Figure 1. Figure 1 illustrate examples of the configuration of burette infusion sets; other configurations may be used provided they lead to the same results. 3.2 The b
19、urette infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. 3.3 If a separate air-inlet device is used, it shall comply with ISO 8536-4. ISO 8536-5:2004(E) 2 ISO 2004 All rights reserved Key 1 protective cap of the closure-
20、piercing device 9 drip tube 2 closure-piercing device a 10 fluid filter c 3 ON/OFF clamp 11 tubing 4 tubing 12 flow regulator 5 injection site b 13 injection site b 6 air inlet with air filter and closure 14 male conical fitting 7 graduated burette 15 protective cap of the conical fitting 8 shut-off
21、 valve a Air inlet with air filter is optional; if an air filter exists, a closure is optional. b Injection site is optional. c The fluid filter may be positioned at other sites, for example preferably near the patient access. Generally a fluid filter has a nominal pore size of 15 m. Figure 1 Exampl
22、e of a burette set -,-,- ISO 8536-5:2004(E) ISO 2004 All rights reserved 3 4 Designation The designation of a burette infusion set (BS), gravity feed (G), which complies with this part of ISO 8536 shall include the indication of burette set, a reference to this part of ISO 8536, the nominal capacity
23、 in millilitres (e.g. 100 ml) and the indication of gravity feed, as follows: Burette set ISO 8536-5 BS 100 G 5 Materials The materials from which the burette infusion set and its components as given in Clause 3 are manufactured shall comply with the requirements in Clause 6. Where components of the
24、 burette infusion set come into contact with solutions, the materials additionally shall comply with the requirements specified in Clauses 7 and 8. 6 Physical requirements 6.1 General Physical requirements for burette infusion sets shall be in accordance with ISO 8536-4 so far as applicable. In addi
25、tion, the burette set shall comply with the requirements in 6.2 to 6.4. 6.2 Design 6.2.1 The burette shall consist of a tube of rigid or semi-rigid plastics material and shall permit observation of fluid in the chamber. 6.2.2 The burette shall be provided with filtered air-venting capability located
26、 in a position above the top graduation mark. 6.2.3 The burette shall be capable of receiving fluid from the main container and of being closed off and serving as a separate self-vented reservoir. 6.3 Volume of burette The nominal volume of the burette shall be designated by the total graduated capa
27、city. 6.4 Graduated scale 6.4.1 The burette scale shall be graduated at intervals as given in Table 1. Table 1 Volume and scale intervals for burettes Scale intervals Numbered scale intervals Nominal volume of burette max. max. Tolerance on any graduated capacity exceeding half nominal volume ml ml
28、ml % 50 1 5 50 5 10 4 ISO 8536-5:2004(E) 4 ISO 2004 All rights reserved 6.4.2 The graduation lines shall be clear, legible and durable lines of uniform thickness, evenly spaced, and they shall lie in planes at right angles to the axis of the burette. 6.4.3 The lengths of the graduation lines shall b
29、e given in Figure 2. The ends may optionally be joined by a line parallel to the longitudinal axis of the burette (see Figure 2). 6.4.4 The graduation lines to be numbered shall be as illustrated in Figure 2. The scale numbers shall be bold, durable and legible, and shall be close to, but not touchi
30、ng, the ends of the graduation lines to which they relate. 6.4.5 The zero position mark on the chamber shall be located in a position which compensates for the volume displaced by any shut-off device, the position of outlet relative to the bottom of the burette or any other feature of the bottom cap
31、 which can affect the reading. Nominal volume: 50 ml 100 ml 150 ml NOTE The vertical lines are optional. Figure 2 Typical graduated scales for use in burette sets -,-,- ISO 8536-5:2004(E) ISO 2004 All rights reserved 5 7 Chemical requirements The requirements of ISO 8536-4 shall apply. 8 Biological requirements The requirements of ISO 8536-4 shall apply. 9 Labelling The requirements of ISO 8536-4 shall apply. 10 Packaging The requirements of ISO 8536-4 shall apply. -,-,- ISO 8536-5:2004(E) ICS 11.040.20 Price based on 5 pages ISO 2004 All rights reserved