ISO 11979-5-2020 pdf free download – Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility.
i ne manuracturer snali proviae a aescription or eacn or ine components in ine rormulation to raciitatethe interpretation of physical and chemical test results.
For description of each component the manufacturer shall provide, if available:
a)Name —Provide the chemical name and Chemical Abstracts Service (CAS) registry number;b)Structure formula— Provide the chemical structure and molecular formula;
)lf the component material is derived from biological sources, the organism from which it is obtainedshall be stated along with its source.
For the finished polymer the manufacturer shall provide, if available:
d) Structure formula — Provide the chemical structure and molecular formula.
5.3 Exhaustive extraction test
The test material shall be tested for extractables under exhaustive extraction conditions in accordancewith the method specified in Annex A. Alternative methods can be used, provided that they have beenvalidated and are reflective of the current state of the art.
The following shall be observed:
a) The reasons for selecting each solvent shall be justified and documented.
b)The test material shall be weighed before and after extraction and any change in mass shall be
calculated.
c) The extraction media shall be qualitatively and quantitatively analysed at the end of extraction
for possible extractable components of the material, such as process contaminants，residualmonomers, additives, and other extractable components.
The results shall be evaluated to assess the risk for potentially harmful effects due to extractablecomponents.
5.4Test for leachables
The test material shall be tested for leachables under simulated physiological conditions in accordancewith the method specified in Annex B.Alternative analytical methods can be used that are reflective ofthe current state of the art in common use.
The following shall be observed:
a)The reasons for selecting each solvent shall be justified and documented.
b) The extraction media shall be qualitatively and quantitatively analysed at the end of extraction for
possible leachables of the material, such as process contaminants, residual monomers, additives,and other leachables.
The results shall be evaluated to assess the risk for potentially harmful effects due to leachablecomponents.
5.5Test for hydrolytic stability
Hydrolytic stability testing shall be conducted in accordance with the method specified in Annex C.
The following shall be observed:
a) The study shall be designed to evaluate the stability of the material in an aqueous environment at
35 °C± 2°C for a period of at least five years or at an elevated temperature for a simulated exposuretime of at least five years.
NOTE Five years is considered sufficiently long to show changes when the product is not hydrolyticallystable and is considered appropriate since only limited test acceleration is possible.
b) The simulated exposure time is to be determined by multiplying the actual study time with the
following acceleration factor F:
F= 2,0(Ta-To)/10
where
T。is the accelerated temperature;
T。is the temperature of the inside of the eye (35 °C).
c)The exposure medium shall be qualitatively and quantitatively analysed for any chemical entities
at the end of the exposure period.
d) The test material shall be examined by light microscopy at ×10 or higher and by scanning electron
microscopy(SEM) at ×500 or higher before and after testing.The test material shall be comparedwith the untreated material and there shall be no significant difference in surface appearance(e.g. bubbles, dendrites, breaks and fissures).
e)optical transmittance spectra of the test material in the ultraviolet and visible spectral regions
(uv/Vis) shall be recorded before and after testing.By comparison of the spectra, assurance shallbe obtained that there are no significant changes in spectral transmittance.
f) The dioptric power shall be determined before and after testing if finished lOLs are used in the
testing. The refractive index shall be determined instead if a facsimile material is used. Thereshall be no average absolute change in dioptric power greater than 0,25 D for a 20 D lens or acorresponding change in refractive index comparing before testing and after exposure to thesimulated time of at least 5 years.
The results shall be evaluated to assess the risk for potentially harmful effects due to instability of thematerial in an aqueous environment.ISO 11979-5 pdf download.