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CSN EN ISO 10555-5
Search the history of over billion web pages on the Internet. Peripheral intravascular catheter designed for the introduction of withdrawal of liquids or devices into or from the peripheral vascular system. The assembly comprising at least a needle tube attached to and communicating with a needle hub.
Other parts of this standard are as follows: Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standard ISO Part 1 General requirements do The technical committee has reviewed the provisions of the following International Standard referred in this adopted standard and has decided that it is acceptable for use in conjunction with this standard: At the time of publication, the editions indicated were valid.
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 recent editions of the standards indicated below.
Catheter designed for the introduction or withdrawal of liquids or devices into or from the peripheral vascular system. Assembly comprising at least a needle tube attached to, and communicating with, a needle hub.
Rigid tube with one end sharpened to facilitate entry into body tissue. Fitting attached to the needle tube, providing communication with its bore.
Fixed or removable fitting per- mitting venting of air while restricting or preferably preventing the escape of blood. Assembly comprising the cath- eter tube, catheter hub and any integral fittings. Blood flow into the needle hub. The catheter tube may have a single lumen or multiple lumens. Figure 1 — Typical over-needle peripheral intravascular catheter NOTE 2 At the time of publication of this part of ISOthere is no acceptable, validated test method to determine radio-detectability.
An approved test method for producing a value of radio-detectability will be established. 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. When the needle is fully inserted into the catheter unit, the catheter tube shall neither extend beyond the heel of the needle bevel nor be nnore than 1 nnnn fronn it see dinnension a in figure 1. If a steel tube is used, it shall connply with ISO The fluid pathway in the needle shall be free of unintended obstructions that would prevent flashback.
Suggested colour references for opaque naaterials are given in annex C. NOTE 3 The point should be designed to be noncoring. Annex D shows examples of typical needle point geom- etries.
BS EN ISO 10555-5:2013
I Principle A force is applied 105555-5 tensile and connpress- ive to the needle tube and needle hub and the tube- hub union is then examined for loosening. I Principle Water is allowed to flow through the catheter and the amount of flow is measured either volumetrically or gravimetrically. An example of a suitable apparatus is shown in fig- ure B.
Round the calculated iao water fiowrate to the nearest whole number of millilitres. Available from Munsell Color, N. Limited collection of colours. Designation and catalogue of CCR colours. Page 3, subclause 4. When tested in accordance with annex E, fluid shall not leak out of the vent fitting within 15 s.
Add the following reference: The fluid is allowed to flow into the needle, and the time taken for fluid to leak through the vent fitting is measured. NOTE To improve the visibility of the solution, a colorant such as red or blue food dye may be incorporated. Measure the time taken for fluid to form the first falling drop at the back of the vent fitting. E-5 Test report The test report shall contain at least the following information: Pages 1 and 2 4.
The details of conditions 100555-5 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.
EN ISO – European Standards
Details of which is given in National Annex A. 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: The number of significant places retained in the rounded off value should be the same as that of the specified value in this standard. Bureau of Indian Standards BIS is a statutory institution established under the Bureau of Indian Standards Act, to promote harmonious development of the activities of standardization, marking and quality certification of goods and attending to connected matters in the country.
Copyright BIS has the copyright of all its publications. No part of the these publications may be reproduced in any form without the prior permission in writing of BIS. 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. Review of Indian Standards Amendments are issued to standards as the need arises on the basis of comments.
Standards are also reviewed periodically; a standard alongwith 1055-5 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.
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: This Indian Standard has been developed from Doc No.: