ISO Hypodermic Needle Standards Updated

Two ISO hypodermic needle standards have been updated.  They are ISO 6009 and ISO 7864.  I will review them separately below since these standards are widely used and contain technical updates.

ISO 6009, 4th Edition, Hypodermic needles for single use – Colour coding for identification

Hypodermic needles are given a color-code to provide a quick way to identify the outer diameter of a single-use needle.  ISO 6009 is the standard that allows manufacturers and users to correctly choose the color for each diameter.  This practice can be challenging for a manufacturer because the colors are often translucent.  Why?  So that air bubbles inside the hub can be seen and elimiated prior to injection.

The changes in this new edition can be found in the following areas:

  • Increased needle size range to include sizes down to 0.18 mm
  • Changes in the use of instrumental measurement of colors
  • Revisions to Annex A and the deletion of Annex B

ISO 7864, 4th Edition, Sterile hypodermic needles for single use – Requirements and test methods

These types of needles are used with syringes (6% Luer conical fittings).  They can be used to either inject or withdraw fluids into the body.   This is a broad-ranging standard.  It covers the needle itself as well as packaging, information to be included by the manufacturer, and so on.

Changes to this standard cover the following areas:

  • Expansion of the gauges
  • A new tapered needle designation
  • New references to the ISO 80369 series, ISO 15223-1, and ISO 23908
  • New Annexes on penetration force, for flow rate, and needle bonding strength
  • Updates to Annex B and Annex C

If you use either of these two ISO hypodermic needle standards, you’ll want to purchase your updates now.  Since both are technical updates, all previous editions are now obsolete (cancelled).

Purchasing standards and keeping up with the changes to the ones you own can be a challenge.  That’s why so many standards users choose Document Center Inc. as their source for compliance information.  Search for and order standards at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 6009 and to the order page for ISO 7864.  All standards purchases come with our “best-in-class” notification service.

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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