ISO 7864:2016 – Sterile hypodermic needles for single use – Requirements and test methods is the latest version of the standard that specifies guidelines for sterile hypodermic needles intended for single use injection or withdrawal of fluids from the body. According to the document, the two standard gauges for hypodermic needles are 0.18 mm and 1.2 mm, and its specifications apply only to those two kinds.
ISO 7864:2016 is the fourth edition of the standard, superseding the third edition that was published back in 1993. As you might imagine, since 23 years is quite a long time, there are many needed changes made to the latest revision that serve to keep it updated and modern. These include:
a) expansion of the range of gauges;
b) introduction of tapered needle designation;
c) reference to the new ISO 80369- series;
d) new informative annex on penetration force;
e) change in Annex B on fragmentation;
f) deleted informative Annex C for symbol for “do-not-reuse” and added normative reference to ISO 15223-1;
g) new informative annex on flow rate;
h) new informative annex on needle bonding strength;
i) reference to ISO 23908 on sharps injury protection.
The above image (Figure 1 from the standard) demonstrates a tapered needle, or a “needle with conical needle tube which has an outer diameter spanning at least two consecutive designated metric sizes,” which is a new addition to the standard. While a typical tubular needle is simply designated by its gauge, tube length, and wall thickness, tapered needles must be designated with the expression OD (tip)/OD (hub) × L.
These variables can be understood as: OD (tip) – the designated metric size of the needle tube at the first full diameter from the tip; OD (hub) – the designated metric size of the needle tube at the hub side, measured at the first full diameter from the top of the hub or from the top of the jointing medium; L – the nominal length of the needle tube.
As previously noted, many of the changes to the newest revision of ISO 7864 are within the annexes of the standard document. Each annex generally covers a concept tangential to the main practice addressed in the document that can significantly benefit its completion. For example, the newly added Annex C covers the means by which one can determine the flow rate through a sample needle.
Additional changes to the ISO 7864:2016 document are intended to carefully harmonize it with newer international standards that were released in the time following its previous publication. This involves the inclusion of referenced documents from the ISO 80369-1 series that were introduced in the past few years. With an understanding of the eventual outdating of existing standards, the normative references section of the document includes ISO 594-1:1986, but mentions that it should be displaced by ISO 80369-7 – Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications, a standard that was published after its release.
Further information on these changes is detailed in the document itself.
ISO 7864:2016 – Sterile hypodermic needles for single use – Requirements and test methods is now available on the ANSI Webstore.
1. International Organization for Standardization (ISO), ISO 7864:2016 – Sterile hypodermic needles for single use – Requirements and test methods (Geneva: ISO, 2016), 4.