Official test systems for sharps penetration resistance

ASTM International has published its new standard  ASTM F2878 Test Method for Protective Clothing Material Resistance to Hypodermic Needle Puncture.

The ASTM standard will advance from the position of  BS EN ISO 13997:1999, Protective clothing — Mechanical properties — Determination of resistance to cutting by sharp objects.

This standard will help ensure that claims for needlestick penetration resistance are defined according to a standardised test method and should provide confirmation that claims are properly substantiated. The tests have many limitations, and compliance with the test standard should not be construed as confirmation of absolute safety or infallibility of any product. It is, however, a significant advantage and purchasers should look for compliance with this standard.

Elsewhere, the standard organisations have been busy. ASTM International put a lot of effort into the preparation of a comprehensive standard for sharps bin performance testing though sadly this did not reach completion due to discord between manufacturers, who were resistant to any improvement to standards and performance testing due to the financial implications of change, and the various user representatives who generally wanted a better designed container that was more robustly tested. To complicate matters, there was much misunderstanding between the various representative groups who largely failed to distinguish between sharps injury to sharps users, ie, during use of needles, and those injuries associated with later disposal of the needle.

Making matters worse, the data we have on post-disposal incidents, where the integrity of the sharps bin becomes crucial, were insufficient to move the manufacturers who see their responsibilities going no further than the immediate purchaser. Thus, concerned about their customer base who include only those placing sharps bins on the shelf and dropping syringes and needles inside, they seem to wash their hands of anyone dealing with those containers as they bounce along the disposal chain.

Presently , ISO are revising the similar standard for sharps bin performance. BS 7320, Specification for Sharps Containers, has been around since 1990, and though it has been an invaluable standard it is now hopelessly out of date.

ISO placed out for public consultation (now closed) two draft standards, BS EN ISO 23908-1, Sharps injury protection – Requirements and test methods – Part 1: Sharps protection features for single-used hypodermic needles, catheters, introducers for catheters and needles used for blood sampling, and BS EN ISO 23907 Sharps injury protection – Requirements and test methods – Sharps containers.

These standards should move forward the degree of protection provided by these equipment items and the final copies are much awaited. However, it must remain on record that the British Standards contribution to ISO is permanently tarnished by the admission of its committee members that they do not take much notice of comments received and thus do not ask for comments! Think of HTM 07-01…sounds familiar, doesn’t it?

1 Comment


  1. Ian,

    Thanks for a great article.

    Here’s another needle puncture test for your round-up –> ISO DRAFT NORM 14876-4 “Protective Clothing – Body Armour – Part 4: Needle and Spike Resistance”. This draft norm is used to qualify body armor against stabbing with a 21g hypodermic needle.

    Under the draft norm, a 21g hypodermic needle is used to manually probe and stab armor panels. It’s a good dynamic method, but hasn’t gained broad adoption yet. I know the Dutch police reference this standard for their armor, but I have not seen it elsewhere.

    As we were developing the ASTM F 2878-10 we had lots of participation from members of CEN TC162 in Europe. In particular, we wanted to make sure that BS EN 388 accreditation labs were able to run our test with existing tooling. So, we reached out to them during our inter-lab studies to make sure we had good repeatability and reproducibility. Our hope is that TC 162 will consider adopting a similar hypodermic needle puncture standard; thus mitigating many of the correlation issues we see with other mechanical threat test methods.

    Again, thank you for a great article. I found it very informative.

    V/R,
    John

    Reply

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