DS/EN ISO 16672
Ophthalmic implants - Ocular endotamponades
| Organization: | DS |
| Publication Date: | 25 April 2003 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Ophthalmic equipment): | 11.040.70 |
scope:
This standard 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 this 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.
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