ISO 16672:2003

Ophthalmic implants — Ocular endotamponades

Ophthalmic implants — Ocular endotamponades

Digital Document2003 edition2003Purchase Options

Referenced standards

EN 1041:1998EN 868-1:1997ISO 10993-1:1997ISO 10993-2:1992ISO 10993-6:1994ISO 11607:1997ISO 13408-1:1998ISO 14155-1ISO 14155-2ISO 14630:1997ISO 14971:2000
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Ophthalmic implants — Ocular endotamponades

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.

Edition2003
Published Date2003
Published ByInternational Standardization Organisation
Page Count13