AS/NZS 2485:1995
$43.55
Medical equipment – Single-use winged intravenous devices (sterile) for general medical use
Published By | Publication Date | Number of Pages |
AS | 1995-10-05 | 45 |
Specifies requirements for sterilized winged devices, generally known as 'scalp vein units', for intravenous use. Appendices include methods of test for biological, chemical and physical requirements.
Scope
This Standard specifies requirements for sterilized winged devices for intravenous use.
NOTE: Materials to be used for the construction of sterile winged intravenous devices for single-use are not specified in detail as their selection will depend, to some extent upon the design, process of manufacture and method of sterilization employed by individual manufacturers. The materials should be compatible with injection fluids included in the European or other relevant pharmacopoeia and, where this is not the case, the attention of the user should be drawn to the exception by labelling the device pack.
It is not practicable to specify a universally acceptable method of test for incompatibility. However, a number of solvents and other fluids selected from pharmacopoeia to represent materials used in injections is provided in Appendix A together with a simple test which may be used to detect visible or functional incompatibility between a winged intravenous device and an injectable fluid.