1 Scope
This International Standard applies to ocular endotamponades (OE), a group of non-solid
implants used in ophthalmology to flatten and position a detached retina onto the
choroid, or to tamponade the retina.
With regard to the safety and efficacy of OE, this International Standard specifies
requirements for their intended performance, design attributes, pre-clinical and clinical
evaluation, sterilization, product packaging, product labelling and the information
supplied by the manufacturer.