BS EN ISO 16672:2015 PDF

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.