Modified:
ISO 9626 has just been updated. The standard is titled “Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods.” The new 2nd Edition from 2016 replaces the 1st Edition from 1991 along with the Amendment 1 from 2001. Both of the old documents are now obsolete. The new update is a technical revision.
The stainless steel tubing in this standard is used in hypodermic needles and other medical devices. I just posted on 2 other ISO hypodermic needle standards that have just been updated on Monday. The ISO 9626 complements them because it specifies the dimensions and mechanical properties of the steel tubing they use.
It’s been a long time since this standard was revised. If you use it, you’ll want to know what the changes are. The ISO committee in charge has given you the following guide to the updates:
- There are additional metric sizes in this standard for “greater comfort” when injecting (particularly for infants and toddlers)
- More wall thicknesses have been added
- Additional minimum inner diameters are included
- The table of tubing dimensions and stiffnesses has been revised
If you remember the amendment 1 for the 1st Edition, the changes were highlighted by the use of bold font in that amendment. However, since the 2nd Edition is a complete update, there are no clues to where the revisions are exactly.
If you use this standard you’ll need to get the new Edition. Be sure to use an authorized ISO distributor like Document Center Inc. as your source. You can search for and order standards at our webstore, www.document-center.com. We have a long history of working with ISO and have all their standards available for you. Here is a direct link to the order page for ISO 9626 for your convenience.
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