ISO-10555-2-1996.pdf
《ISO-10555-2-1996.pdf》由会员分享,可在线阅读,更多相关《ISO-10555-2-1996.pdf(9页珍藏版)》请在三一文库上搜索。
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
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ISO 10555 1996
链接地址:https://www.31doc.com/p-3773867.html