ISO 11979-1 pdf download – Ophthalmic implants – Intraocular lenses — Part 1: Vocabulary

ISO 11979-1 pdf download – Ophthalmic implants – Intraocular lenses — Part 1: Vocabulary.
2.13
custom-made device
any device specifically made in accordance with a duly qualified medical practitioner’s written prescription, which gives, under his responsibility. specific design characteristics and is intended for the sole use of a particular patient
NOTE Mass-produced devices, which need to be adapted to meet the specific requirements of the medical practitioner, are not considered to be custom-made devices.
2.14
cut-oft wavelength
minimum wavelength at which the transmission reaches and remains below a defined level
2.15
cylindrical power
difference in dioptric power between the meridians with the highest and the lowest dioptric powers
2.16
device history record
collection of records and reports assembled in a batch package, containing, or referring to, the relevant information pertaining to the manufacture and control of that batch of devices
2.17
device intended for clinical investigation
any device intended for use by a duly qualified medical practitioner when conducting a clinical investigation
2.18
dioptric power
reciprocal of the reduced paraxial focal length in situ for light with a wavelength of 546.07 nm, where paraxial focal length is the distance between the back principal plane and the back paraxial focal point, and reduced paraxial focal length is the paraxial focal length divided by the refractive index of the surrounding medium
NOTE The unit for expressing dioptnc power is the reciprocal metre (m). The special name for this unit is dioptre”, for which the symbol D is used.
2.19
distance power base power
far power
power that is intended to provide an in-focus image of an object at infinite distance
2.28
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. configuration. calibre, angulation), and the material(s) used in its construction have been fully specified
NOTE Any significant change in the specification of the materials (including their formulation or synthesis procedures) will result in it being considered a new model.
2.29
loop
peripheral extension on the body serving to position the intraocular lens in the eye
NOTE Loops are parts of the haptic (2.24) or can be the haptic.
2.30
lost-to-follow-up 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 determine the final clinical outcome
NOTE This category does not include subjects who died.
2.31
manufacturer
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 himself or on his behalf by a third party
NOTE The obligations to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels a product with a view to its being placed on the market under his own name.
2.32
material degradation test
test that determines the potential for degradation of
a material
2.33
meridian of highest dioptric power
meridian with the most positive or least negative dioptric power which is orthogonal to that defined in 2.34
2.44
ocular Implantation test
test that evaluates the reciprocal tolerance of a test material and local tissue after implantation into the anterior segment of the eye of an appropriate animal
2.45
one-piece intraocular lens
intraocular lens where the haptic forms an integral part with the body
2.46
optic
image-forming, generally central component of an intraocular lens
2.47
optical power of the eye
reciprocal of the reduced focal length of an eye
248
optic decentratlon
lateral displacement of the optic due to compression of the haptic(s), measured as the distance between the geometrical centre of the clear optic and the centre of a cylinder of prescribed diameter to which the intraocular lens is confined
2.49
optic shape factor
term associated with the curvatures of the retracting surfaces of the optic (e.g. planoconvex, bi-convex)
NOTE The optic shape factor is determined using the following equation.