Sterile, single-use intravascular catheters – Part 2: Angiographic catheters (ISO ); German version EN ISO The European Standard EN ISO has the status of a Swedish Standard. This docu- ment contains the official English version of. ISO Intravascular catheters — Sterile and single-use catheters —. Part 5: Over-needle peripheral catheters. Cathéters intravasculaires.
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In this adopted standard, reference appears to the following International Standard for which Indian Standard also exists. Shape of the catheter which is designed to facilitate lso manual manipulation through the cardiovascular system and the placement of the tip in the location chosen for the angiographic procedures. The corresponding Indian Standard which is to be substituted in its place is listed below along with its degree of equivalence for the editions indicated: Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of ‘BIS Catalogue’ and ‘Standards: For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated expressing the result of a test or analysis, shall be rounded off in accordance with IS 2: Search the history of over billion web pages on the Internet.
NOTE 2 At the time of publication of this part of ISOthere is no acceptable, validated test method to determine radio-detectability. Copyright BIS has the copyright of all its publications. All standards are subject to revision, and parties to agreements based on this part of ISO are encouraged to investigate the possibility of applying the most 10555-2 editions of the standards indicated below. The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard.
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Other parts of this standard are as follows: This Indian Standard has been developed from Doc No.: After the pressure has been removed, disconnect the catheter from the test apparatus and examine it for damage, rupture or evidence of leakage. Review of Indian Standards Amendments are issued to standards as the need arises on the basis of comments. Subcommittee SC 1, Syringes, sio and intravascular catheters for single use.
The apparatus for generating and con- trolling the pressure is not shown in detail, as it may vary in design, complexity and degree of automation. The details of conditions under which the licence for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards.
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This does not preclude the free use, in the course of implementing the standard, of necessary details, such as symbols and sizes, type or grade designations. Attention is particularly drawn to the following: If the inside diameter of the catheter is addi- tionally designated, it shall be expressed in milli- metres, rounded down to the nearest 0,1 mm.
Angiographic Catheters [MHD Sterile, single-use intravascular catheters, Part 2: Disclosure to Promote the Right To Information Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.
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.
BS EN ISO – Sterile, single-use intravascular catheters. Angiographic catheters
Standards are also reviewed periodically; a standard alongwith amendments is reaffirmed when such review indicates that no changes are needed; if the review indicates that changes are needed, it is taken up for revision. Until that time, 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. Certain conventions are, however, not identical to those used in Indian Standards.
An approved test method for producing a value of radio-detectability will be established.
No part of the these publications may be reproduced in any form without the prior permission in writing of BIS. Technical Corrigendum 1 to the above International Standard has been given at the end of this standard. Details of which is given in National Annex A. At the time of publication, the edition indicated were valid.
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.
Izo shape of the catheter is designed to facilitate its manual manipulation through the cardiovascular system and the placement of the tip in location chosen for the angiographic procedures. Attempt to pass the ring gauge freely along the test portion of the catheter shaft.