In our presentation, we will examine the new requirements of Annex 1 with a focus on ultra-pure media systems and the potential impact the new revision is likely to have on operators and suppliers. The chapters and requirements relevant to high-purity media systems and the consequences derived from them from our point of view will be discussed. The main focus here is on requirements with a direct impact on water for injection and pure steam systems and the extent to which these differ from standard practice.