DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 16672
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015); German version EN ISO 16672:2015
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2015); Deutsche Fassung EN ISO 16672:2015
Overview
The standard DIN EN ISO 16672 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 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. The responsible German standardization committee is Working Committee is NA 027-01-20 AA "Intraokulare Medizinprodukte" ("Intraocular medical devices") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).
Document: references other documents
Responsible national committee
NA 027-01-20 AA - Intraocular medical devices
