ISO 11979-1:2012 pdf download – Ophthalmic implants -Intraocular lenses 一 Part 1: Vocabulary
ISO 11979-1:2012 pdf download – Ophthalmic implants -Intraocular lenses 一 Part 1: Vocabulary.
any device specifically made in accordance with a duly qualified medical praclitioriers written prescnption, which gives, under his responslity. specific desgn characteristics and Is intended for the sole use of a particular patient
NOTE Mass•produced devices. wliich need io be adted io meet the specilic requIrements of the medical practitioner. are not considered to be custommade devices
minimum wavelength at which the transmisson reaches and remains below a defined level
ditterence in dioptflc power between the meridians with the highest and the lowest dioptric powers
device history record
collection of recoids and reports assembled in a batch package. containing, or relerring to. the relevant information pertaining to the manufacture and control of that batch of devices
device intended for clinical investigation
any device intended for use by a duty qualified medical practitioner when conducting a dinical investigation
reciprocal at the reduced paraxial focal length in situ br light with a wavelength ot 546.07 nm. where paraxial focal length is the distance between the back principal plane and the back paraxial focal point, and reduced paraxial local length is the paraxial focal length divided by the refractive index of the surrounding medium
NOTE The unit for expressing diopaic power is the reciprocal metre (rn1). The special name for this unit Is optre. tom which lbs symbol 0 Is used
distance power base power
power that is intended to provide an in-focus image of an object at infinite distance
Intraocular lens model
identification by which the features of an intraocular lens, including its body (e.g. body diameter, optic diameter, optic shape factor) and its loops (e.g. configuratn, calbe, angulation). and the material(s) used In its construction have been fully specified
NOTE Any sificanI change in the speciltcabon of the matenals (including their lonrndabon or synthesis procedures) will result in It being considered a new model.
peripheral extension on the body serving to position the intraocular lens In the eye
NOTE Loops are paris of the haptic (224) or can be the haptic.
lost-to-f o1lowup subject
subject for which the final post-operative case report form Is overdue and who cannot be contacted despite extensive written and telephone follow-ups to deternine the final clinical outcome
NOTE This category does not include sijects who died.
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person hwnself or on his behalf by a third party
NOTE The obligations to be met by manufacturers also app’y to the natural or legal person who assembles, packages, processes, fully rets’bishes andor labels a product with a view to its being placed on the market under his own name.
material degradation test
te5t that determines the potential for degradation of
merIdian of highest diopiric power
meridian with the most positive or least negative dloptric power which is orthogonal to thai defined In 2.34
meildlan of lowest dloptrlc power meridian with the least positive or most negative diopiric power which Is orThogonal to that detined in 233
monofocal intraocular lens intraocular lens with two rotationally symmetric optical surfaces having one primary focus
multifocal Intraocular lens
intraocular lens having two or more foci
multi-piece Intraocular lens
intraocular lens assembled from separate loop and body coaonents
NOTE An inraociiar lens with a body and Iwo loops is oflen reterred to as a ttireepiece intraocular lens,
Nd-VAG laser exposure test
test that determines the physical and chemical effects of Nd-YAG laser exposure on a test material
nearest distance at which one can focus on an object
power that is intended to provide an in-focus image of a near object
near power configuration
configuration of an accommodating intraocular lens
m the eye thetis intended to result in a near-object
in-focus in the retinal plane
non-ocular implantation test
test that evaluates the reciprocal tolerance of a test material and local tissue after implantation of the test material in a non-ocular site in an animal
lens used to neutralize tone lens cylinder power.