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: If submitting Accelerated Aging data to support Shelf life, please confirm start date and expected completion date for real time Packaging studies 5. Please list and supply all relevant reports which substantiate Packaging shelf life – 6. SECTION 8: BIOCOMPATIBILITY Is the biocompatibility status of the device affected by this Yes No change 1. If “no” please explain: Is compliance with EN ISO 10993-1 latest version claimed Yes No 2. If “no” please explain: Please identify additional testing requirements in Table 3.
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. If submitting Accelerated Aging data to support Shelf life, please confirm start date and expected completion date for real time Packaging studies 6. Please list and supply all relevant reports which substantiate Packaging shelf life – SECTION 8: BIOCOMPATIBILITY 1. Is the biocompatibility status of the device affected by this change Yes No If “no” please explain: 2. Is compliance with EN ISO 10993-1 latest version claimed Yes No If “no” please explain: 3. Please identify additional testing requirements in Table
GRF-25-45a.docx