Rationale

The standard was last revised in 2018 and reapproved in 2022. There are several reasons for the need for substantial revision: - The experience gained whilst dealing with the PIP scandal of 2010 identified improvements in standards such as F703 that would help address similar issues in the future. - There is growing evidence that the incidence of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is related to the surface texture the breast implants. This in turn has highlighted that the characterisation of the surface texture of breast implants needs to be improved and standardised to aid future research of the disease. - The associated ISO standard (ISO 14607:2024) had been revised several times in the intervening period and there was number of perhaps unnecessary discrepancies between the two standards.