AS 3825:2020 – Procedures and devices for the removal,containment and disposal of scalpel blades from scalpel handles.
The number of size 15 scalpel blades equal to the number of chambers in one device. (iv) The number of size 22 scalpel blades equal to the number olchambers in one device.
WARNING: The use of blunt scalpel blades or cut-resistant gloves is recommended in order to ensure operator safety.
(c) Where testing a multiple-use device, the following:
(I) One device.
NOTE 3 This device can be reused for Appendix B if desired.
(ii) Bracket or fixation device, if specified by the manufacturer.
(iii) Five size 15 scalpel blades.
(lv) Five size 22 scalpel blades.
WARNING: The use of blunt scalpel blades or cut-resistant gloves Is recommended in order to ensure operator safety.
This Appendix sets out the procedure for determining whether the scalpel blade removal device can be operated with a single•handed action, as required by Clause 4(a). and the removed scalpel blade is immediately contained, as required by ClauseAL).
A.2 Principle
The scalpel blade removal device is tested in accordance with the manufacturer’s instructions, including the use ofa bracket or similar fixation device if specified, to ensure that a scalpel blade can he removed from a reusable scalpel handle by the operator using only one hand and that the scalpel blade is immediately contained within the device.
A.3 Apparatus
Use the following apparatus:
(a) Reusable scalpel blade handles, sizes 3 and 4.
NOTE 1 The number ol reusable handles required is at the discretion of the test house.
(b Where testing a single-use device, the following:
(i) Two devices.
NOTE 2 These devices can be reused for Appendix B If desired.
(ii) Bracket or fixation device, if specified by the manufacturer.
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 1 m is considered appropriate.
A.4.2 Single-use scalpel blade removal device
A.4.2.l 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 removal device by following the manufacturer’s instructions.
(c) Where the device has more than one chamber, repeat step (b) for each chamber.
(d) Using the second device, repeat steps (a) to (c) using a size 4 scalpel handle loaded with a size 22 scalpel blade.
A.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.
A.4.2.3 Report
Report the following information:
(a) Whether the device passes or tails.
(b) The reasons for any failures.
(c) Reference to this test method i.e. AS 3825:2020 Appendix A.
A.4.3 Multiple-use scalpel 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) five times.
(d) Repeat steps (b) and (c) using a size 4 scalpel handle loaded with a size 22 scalpel blade.