Projekta Nr.ISO 11979-10:2018
Nosaukums<p>ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.</p> <p>There are three main categories of phakic intraocular lenses depending on the optical design:</p> <p>a) Phakic monofocal (PIOL);</p> <p>b) Phakic multifocal (PMIOL); and</p> <p>c) Phakic toric (PTIOL).</p> <p>Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.</p> <p>The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.</p> <p>ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.</p>
Reģistrācijas numurs (WIID)69036
Darbības sfēra<p>ISO 11979-10:2018 specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.</p> <p>There are three main categories of phakic intraocular lenses depending on the optical design:</p> <p>a) Phakic monofocal (PIOL);</p> <p>b) Phakic multifocal (PMIOL); and</p> <p>c) Phakic toric (PTIOL).</p> <p>Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.</p> <p>The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.</p> <p>ISO 11979-10:2018 addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.</p>
StatussStandarts spēkā
ICS grupa11.040.70