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1、INTERNATIONAL STANDARD IS0 10555-211996 TECHNICAL CORRIGENDUM 1 Published 2002-06-1 5 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION MMYWOflHAFI OPTAHMWMFI no CTAHWTMWMM ORGANISATION INTERNATIONALE DE NORMALISATION Sterile, single-use intravascular catheters - Part 2: Ang i og rap h i c catheters TE
2、CHNICAL CORRIGENDUM 1 Cathters intravasculaires striles, non rutilisables - Partie 2 : Cathters angiographiques RECTIFICATIF TECHNIQUE I Technical Corrigendum 1 to International Standard IS0 10555-2: 1996 was prepared by Technical Committee ISOiTC 84, Medical devices for injections, Subcommittee SC
3、1, Syringes, needles and intravascular catheters for single use. Page 1 4.2 Radio-detectability Delete the entire Note 2 given in this subclause. Page 2 4.5 Information to be supplied by the manufacturer Renumber Notes 3 and 4 given in this subclause to become Notes 2 and 3. ICs 11.040.20 O IS0 2002
4、 -All rights reserved Printed in Switzerland Ref. No. IS0 10555-2:1996/Cor.l:2002(E) IS0 10555-2 96 485L703 Obb2184 910 I NT E R NAT I O NAL STANDARD IS0 10555-2 First edition 1996-06-1 5 Sterile, single-use intravascular catheters - Part 2: Angiographic catheters Cathters intravasculaires striles,
5、non rutilisables - Partie 2: Cathters angiographiques This material is reproduced from IS0 documents under International Organization for Standardization (ISO) Copyright License number IHSllCCl1996. Not for resale. No part of these IS0 documents may be reproduced in any form, electronic retrieval sy
6、stem or otherwise, except as allowed in the copyright law of the country of use, or with the prior written consent of IS0 (Case postale 56,1211 Geneva 20, Switzerland, Fax +4122 734 I O 79), IHS or the IS0 Licensors members. Reference number IS0 10555-2:1996(E) IS0 10555-2 96 = Li851903 Obb2185 57 I
7、S0 10555-2:1996(E) Foreword IS0 (the International Organization for Standardization) is a worldwide fed- eration 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
8、subject for which a technical committee has been established has the right to be rep- resented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. IS0 col- laborates closely with the International Electrotechnical Commis
9、sion (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are cir- culated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Internat
10、ional Standard IS0 10555-2 was prepared by Technical Committee ISOflC 84, Medical devices for injections, Subcommittee SC 1, Syringes, needles and intravascular catheters for single use. IS0 10555 consists of the following parts, under the general title Sterile, single-use intravascular catheters: -
11、 Part 7 : General requirements - Part 2: Angiographic catheters - - - Annex A forms an integral part of this part of IS0 10555. Annex B is for information only. Part 3: Central venous catheters Part 4: Balloon dilatation catheters Part 5: Over-needle peripheral catheters O IS0 1996 All rights reserv
12、ed. Unless otherwise specified, no part of this publication may be repro- duced or utilized in any form or by any means, electronic or mechanical, including photo- copying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case Postale 56
13、CH-1 21 1 Genve 20 Switzerland Printed in Switzerland II IS0 10555-2 96 m 4851903 0bb218b 793 m INTERNATIONAL STANDARD 0 IS0 IS0 10555-2:1996(E) Sterile, single-use intravascular catheters - Patt 2: Angiographic catheters 1 Scope This part of IS0 10555 specifies requirements for angiographic cathete
14、rs supplied in the sterile con- dition, and intended for single use. NOTE 1 Attention is drawn to IS0 11 070, which specifies requirements for accessory devices for use with intravascu- lar catheters. 2 Normative reference The following standards contain provisions which, through reference in this t
15、ext, constitute provisions of this part of IS0 10555. At the time of publication, the edition indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 10555 are encouraged to investigate the possibility of applying the most recent editions of t
16、he standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Stan- dards. IS0 10555-1 : 1995, Sterile, single-use intravascular catheters - Part I: General requirements. 3 Definitions For the purposes of this part of IS0 10555, the defi- nitions given in I
17、S0 10555-1 and the following defi- nitions apply. 3.1 angiographic catheter: Intravascular catheter used for the injection or infusion of contrast media and/or fluids and which may be used for pressure measurements and to obtain blood samples. 3.2 distal end configuration: Shape of the catheter whic
18、h is designed to facilitate its manual manipulation through the cardiovascular system and the placement of the tip in the location chosen for the angiographic procedures. 4 Requirements 4.1 General Unless otherwise specified in this part of IS0 10555, catheters shall comply with IS0 10555-1. 4.2 Rad
19、io-detectability The catheter shall be radio-detectable NOTE 2 At the time of publication of this part of IS0 10555, there is no acceptable, validated test method to determine radiodetectability. An approved test method for producing a value of radio-detectability will be established. Until that tim
20、e. a manufacturer may label his product “radio- opaque“ provided he can support this claim by demonstrat- ing that he has an appropriate method for showing radio- opacity. 4.3 Designation of nominal size The nominal size of the catheter shall be designated in accordance with IS0 10555-1 and also by
21、the diam- eter of the largest guidewire that can be used with the catheter. If the inside diameter of the catheter is addi- tionally designated, it shall be expressed in milli- metres, rounded down to the nearest 0,l mm. 1 IS0 10555-2:1996( E) IS0 10555-2 96 4851903 0662187 62T W 0 IS0 4.4 Physical
22、requirements 4.4.1 Tip configuration In order to minimize trauma to vessels during use, the tip of the distal end should be smooth, rounded, tapered or similarly finished. 4.4.2 Freedom from leakage and damage under high static pressure conditions When tested as described in annex A, there shall be
23、no liquid leakage from the catheter and no visible signs of damage. There shall be no permanent defor- mation of the catheter shaft sufficient to prevent the free movement of a ring gauge over the tested portion of the catheter. 4.4.3 Side holes 4.5 Information to be supplied by the manufacturer Inf
24、ormation supplied by the manufacturer shall comply with IS0 10555-1 and shall also include the following: a) nominal size of the catheter, as designated in 4.3; b) depiction or description of the distal end configur- ation, if not identifiable through the package; c) maximum rated injection pressure
25、, expressed in kilopascals (kPa), as determined under dynamic test conditions. NOTES 3 The time for which the catheter can withstand the maximum rated pressure may also be given. 4 Units of measurement systems other than those speci- fied in this part of IS0 10555 may additionally be used. The desig
26、n, number and positioning of side holes should be such as to minimize adverse effects on the catheter and trauma to the tissues. 2 0 IS0 IS0 10555-2 96 Y851903 Ob62188 566 IS0 10555-2:1996(EI Annex A (nor mat ive) Test for freedom from leakage and damage under high static pressure conditions A.l Pri
27、nciple The catheter is connected via its hub or proximal end to a source of hydraulic pressure. Pressure is applied for a fixed time, and the specimen examined for rup- ture and leakage under pressure, and for evidence of leakage, damage or distortion after the pressure is removed. A.2 Apparatus A.2
28、.1 Hydraulic pressure-generating device, which uses only liquid as a pressurizing fluid and maintains its temperature at (37 f 2) OC. A.2.2 Leak-proof connector. A.2.3 Locking device, for securing the catheter to the connector (A.2.2). A.2.4 Means of occluding the catheter, for example a clamp. A.2.
29、5 Ring gauges for each size of catheter, each having an inside diameter 10 % greater than the nominal outside diameter of the catheter shaft. NOTE 5 The general arrangement of the apparatus is shown in figure A.l. The apparatus for generating and con- trolling the pressure is not shown in detail, as
30、 it may vary in design, complexity and degree of automation. A.3 Test procedure WARNING- It is essential that precautions and safeguards be taken to protect the test operator from the consequences of failure of the pressur- ized system and the resulting escape of liquid under high pressure. A.3.1 St
31、art the filtration system (see figure A.l), if fitted. A.3.2 Bring the pressurized liquid and the catheter to a temperature of (37 f 2) O C , and maintain this temperature throughout the test. A.3.3 Attach the free end of the hub of the catheter to the connector (A.2.2). securing it with the locking
32、 device (A.2.3). A.3.4 Ensure the air is displaced from the catheter by the liquid, then occlude the catheter at a distance of approximately one-half its effective length from the catheter hub, using the clamp (A.2.4). A.3.5 Check the hydraulic circuit for integrity and freedom from leaks. A.3.6 Adj
33、ust the pressure-generating device ( A 2 1 ) so that it will apply the maximum rated pressure stated by the manufacturer of the catheter under test for a time of 2 s or the maximum time stated by the manufacturer of the catheter under test, whichever is longer. A.3.7 Apply the selected pressure for
34、the selected time. A.3.8 While the pressure is being applied, inspect the catheter for rupture and leakage (.e. formation of one or more falling drops of liquid). After the pressure has been removed, disconnect the catheter from the test apparatus and examine it for damage, rupture or evidence of le
35、akage. Attempt to pass the ring gauge freely along the test portion of the catheter shaft. A.4 Test report The test report shall include the following information: identity of the catheter; rated pressure and pressurization time used; whether leakage occurred from the test portion of the catheter; w
36、hether the test portion of the catheter was damaged or ruptured; whether the ring gauge could be passed freely along the tested portion of the catheter shaft. 3 IS0 30555-2 b 4853903 Ob62389 4T2 IS0 105!55-2:1996(E) 9 8 7 /” / .I. Hydraulic pressure generator and control system (A.2.1) Connector (A.
37、2.2) Locking device (A.2.3) Clamp or plug (A.2.4) Catheter under test Example of test chamber Spent liquid return (optional) Reservoir for pressurizing liquid Filtration system (optional) I 2 3 -4 5 6 Figure A.l- General arrangement of test apparatus for assessing freedom from leakage and damage und
38、er high static pressure conditions 4 IS0 IS0 10555-2 96 = 4853903 Obb2190 114 = IS0 10555-2:1996(EI Annex 8 (informative) Bibliography 1 IS0 1 1070:-1), Sterile, single-use intravascular catheter introducers. 1) To be published. 5 IS0 10555-2:1996(E) ICs 1 1.040.20 Descriptors: medical equipment, sterile equipment, disposable equipment, vascular system, catheters, specifications, tests, designation, consumer information. Price based on 5 pages