1.1 This test method covers the detection of holes in medical gloves. 1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test. 1.3 The smallest hole that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method. 1.4 The safe and proper use of medical gloves is beyond the scope of this test method.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.