Logo

ISO 23908:2024

Historical Revision

Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

$124.00

$124.00

$210.80


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


Document Preview Not Available...

This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances.

The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use.

The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision.

This document does not cover

—     devices for medication loading and transfer, utilizing a blunt tip design, or

—     invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures

because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device.

This document does not cover solid-core needles used for surgery (e.g. suture needles).


SDO ISO: International Organization for Standardization
Document Number ISO 23908
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 84
Publish Date Document Id Type View
Not Available ISO 23908:2011 Revision
Not Available ISO 23908:2024 Revision