AS 3825:2020 pdf free download – Procedures and devices for the removal,containment and disposal of scalpel blades from scalpel handles

AS 3825:2020 pdf free download – Procedures and devices for the removal,containment and disposal of scalpel blades from scalpel handles.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document:
NOTE Documents for informative purposes are listed in the Bibliography
AS 4031, Non•reusable containers)ór (he collection of sharp medical i1ems used in health care areas
AS/NZS 4261. Reusable containers for the collection of sharp items used in humun and animal medical
applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3,1
chamber
that part of the scalpel blade removal device which fully encloses the scalpel blade alter Its removal
3.2
container
receptacle intended for the collection and containment of scalpel blade removal devices
3.3
containment
complete enclosure of the scalpel blade within a chamber of the scalpel blade removal device following removal
3.4
loaded
physical state wherein a scalpel blade is attached to a scalpel handle, ready for use
3.5
may
indicates the existence of an option
3.6
removal
separation of the scalpel blade from the scalpel handle prior to containment
3.7
resheathing-type removal action
physical actIon wheieby the usei ui other person holds a loaded scalpel handle with one hand and attempts to remove the scalpel blade with a device held in the other hand
A.4 Procedure
A.4.1 General
Conduct the test at (21 ± 2) °C and at the normal working height of the device.
NOTE A height of approximately I m is considered appropriate.
A.4.2 Single-use scalpel blade removal device
A.4.2.1 Method
Proceed as follows:
(a) Assemble the device, including the bracket or fixation device if specilied by the manufacturer, in accordance with the manufacturer’s instructions.
(b) Load the size 3 scalpel handle with a size IS scalpel blade. Using the dominant hand only. attempt to remove the scalpel blade with the removal device by following the manufacturer’s instructions,
(c) Where the device has more than one chamber, repeat step (b) for each chamber.
(d) tising the second device, repeat steps (a) to (c) using a size 4 scalpel handle loaded with a size 22 scalpel blade.
*4.2.2 Interpretation of results
The scalpel blade removal device meets the requirements of Clause 4(a) and 4(c) if all blades are successfully removed from the loaded scalpel handle and contained within the device.
*4.2.3 Report
Report the tollowing information:
(a) Whether the device passes or fails.
(b) The reasons for any failures.
(c) Reference to this test method i.e. AS 3825:2020 Appendix A.
A.4.3 Multiple-use scalpcl blade removal device
A.4.3.1 Method
Proceed as follows:
(a) Assemble the device, including the bracket or fixation device if specified by the manufacturer, in accordance with the manufacturer’s instructions.
(b) Load the size 3 scalpel handle with a size 15 scalpel blade. Using the dominant hand only, attempt to remove the scalpel blade with the scalpel blade removal device by following the manufacturer’s instructions.
(c) Perform step (b) live times.
(d) Repeat steps (b) and (c) using a size 4 scalpel handle loaded with a size 22 scalpel blade.
A.4.3.2 Interpretation of results
The scalpel blade removal device meets the requirements of Clause (a] and 4c] if all blades aresuccessfully removed from the loaded scalpel handle and contained within the device.
A.4.3.3 Report
Report the following information:
(a) whether the device passes or fails.
(b) The reasons for any failure.
(c) A reference to this test method, i.e.AS 3825:2020 Appendix A.