This part of YY/T 0616 specifies the shelf life requirements of disposable gloves. Labeling and disclosure requirements regarding the test methods used are also specified. This section applies to existing, new and products with significant design changes. Existing designs for which aging data are not available should be produced within a reasonable period of time. Batch sizes are not specified in this section. Be aware of the difficulties in circulation and control of large batches. The recommended maximum quantity for a production batch is 500 000.
YY/T 0616.2-2016 Referenced Document
GB/T 19633 Packaging for terminally sterilized medical devices
YY/T 0616.2-2016 history
2016YY/T 0616.2-2016 Medical glove for single use.Part 2:Requirements and testing for shelf life determination