NEN-EN 455-3
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Organization: | NEN |
Publication Date: | 1 March 2022 |
Status: | inactive |
Page Count: | 42 |
ICS Code (Hospital equipment): | 11.140 |
scope:
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
NOTE Medical gloves labelled as single use are medical devices for single use only according to the Regulation (EU) 2017/745. A single use medical device means a device that is intended to be used on one individual during a single procedure.