SRPS EN ISO 16672:2016

Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)

Scope

ISO 16672:2015 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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.