Objetivo: ISO specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials . Find the most up-to-date version of ISO at Engineering Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixed -dose immunization (ISO ); German version EN ISO
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Search the history of over billion web pages on the Internet. Full text of ” IS The preparation of this standard was recognized as a high priority requirement to prevent the re-use of fixed dose immunization syringes in the developing and transitional countries.
Re-use of injection equipment in the absence of sterilization has increasingly let to transmission of blood-borne pathogens this standard.
NBN EN ISO | NBN
This standard is intended to cover ‘fixed dose’ immunization syringes that are rendered inoperable after delivery of the intended dose. These syringes are not covered by Parts 1 and 2 of this standard.
It is recognized that syringes designed to reduce the risk of needlestick injuries, in addition to preventing sharps injuries, may also comply with this part of standard with regard to their auto-disable properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in this standard. 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: Syringes for manual use IS International Standard ISO Upon delivering a fixed dose of vaccine, the syringe is automatically rendered unusable.
This part of ISO does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer. This part of JSO is not applicable to syringes for use with insulin specified in ISOsyringes made of glass specified in ISOsyringes for use with power-driven syringe pumps specified in ISOauto- disable syringes for variable dose delivery and syringes designed to be prefilled.
For dated references, only the edition cited applies.
For undated references, sio latest edition of the referenced document including any amendments applies. Water for analytical laboratory use — Specification and test methods ISO Sterile hypodermic needles for single use ISO Syringes for manual use ISO Figure 1 — Schematic representation of auto-disable syringe for fixed dose IS Part 3: These lines shall be of uniform thickness.
They shall lie in planes at right angles to the axis of the barrel. IS Part 3: 788-63 piston shall not become detached from the plunger when tested in accordance with Annex B of ISO The plunger should be of a length adequate to allow the piston properly to deliver the designated fixed dose.
It should not be possible to defeat the auto-disable feature by removing and re-inserting the plunger. The projection of the plunger and the configuration of the push-button should be such as to allow the plunger to be operated without difficulty.
When the fiducial line of the piston coincides with the 78863 graduation line, the preferred minimum length of the plunger iao the surface of the finger grips nearer to the push-button shall be 8 mm.
NOTE Annex B gives a suggested test method and performance criteria for the forces required to move the plunger. Needle tubing shall be in accordance with ISO Both the needle and the syringe shall be rendered incapable of re-use after delivery of the intended fixed dose, under normal conditions of use.
When a syringe with integrated needle is tested in accordance with Annex 8 of ISO For syringes with integrated needle, 14,2 of ISO No secondary or additional action on the part of the user shall be required. The timing of the activation of the auto-disable feature may vary by design, typically within the ranges described below: In all cases, once the auto-disable feature has been activated: Eject the contents and combine them in a vessel made of borosilicate glass A.
Connect the nozzle of the syringe to the tubing of the reservoir B. Maintain the water and the syringe at this temperature. Adjust the relative positions of the syringe and reservoir so that the water level in the reservoir is approximately level with the mid-point of the syringe barrel. Connect the needle of the syringe to the rubber stopper of the tubing of the reservoir B.
NBN EN ISO 7886-3
Adjust the relative positions of the syringe and reservoir so that the water level in the reservoir is approximately level with the mid-point of the syringe barrel- B. Stop the plunger travel and readjust the recorder to zero. Using the test device C.
Increase the force to a jso of N or until the plunger is capable of delivering a second dose from the same syringe. 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. Details of which is given in National Annex A.
For the purpose of deciding whether a particular requirements 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.
BS EN ISO 7886-3:2009
78886-3 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. 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; Monthly Additions’.
This Indian Standard has been developed from Doc No.: