Please confirm the number of sterilisation cycles that the device 2. and packaging were subjected to prior to stability testing - Please describe the preconditioning applied (eg. Ageing, transport 3. etc): Is compliance with EN ISO 11607 latest version claimed Yes No 4. If “no” please justify: Please list and supply all relevant reports which substantiate the claimed Packaging shelf life – 5. Section 10: BIOCOMPATIBILITY Please confirm the categorisation of the devices with respect to Body Contact and Duration of Contact in Table 6 below & the testing conducted in Table 7 Is compliance with EN ISO 10993-1 latest version claimed Yes No 1. If “no” please justify: 2.
2. Please confirm the number of sterilisation cycles that the device and packaging were subjected to prior to stability testing - 3. Please describe the preconditioning applied (eg. Ageing, transport etc): 4. Is compliance with EN ISO 11607 latest version claimed Yes No If “no” please justify: 5. Please list and supply all relevant reports which substantiate the claimed Packaging shelf life – Section 10: BIOCOMPATIBILITY Please confirm the categorisation of the devices with respect to Body Contact and Duration of Contact in Table 6 below & the testing conducted in Table 7 1. Is compliance with EN ISO 10993-1 latest version claimed Yes No If “no” please justify: 2.
GRF-25-50a.docx