ISO 16672:2003 applies to ocular endotamponades (OEs), 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 OEs, ISO 16672:2003 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.
Status: WithdrawnPublication date: 2003-02
Edition: 1Number of pages: 13
Technical Committee: ISO/TC 172/SC 7 Ophthalmic optics and instruments