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YY 0290.5-2008: [YY/T 0290.5-2008] Ophthalmic implants. Intraocular lenses - Part 5: Biocompatibility
YY/T 0290.5-2008 (Renamed from YY 0290.5-2008)
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 40
YY 0290.5-2008
Replacing YY 0290.5-1997
Ophthalmic implants - Intraocular lenses - Part 5:
Biocompatibility
(ISO 11979-5:2006, MOD)
ISSUED ON: OCTOBER 17, 2008
IMPLEMENTED ON: JUNE 01, 2010
Issued by: China Food and Drug Administration
According to the Announcement of the Medical Device Industry
Standard of National Medical Products Administration (No. 76, 2022),
this Standard will be converted into a recommendatory standard from
September 7, 2022. It will no longer be mandatory.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 General requirements applying to biocompatibility evaluation of intraocular lenses 7
5 Physicochemical tests ... 8
6 Biological tests ... 11
Annex A (normative) Exhaustive extraction test ... 14
Annex B (normative) Test for leachables ... 17
Annex C (normative) Hydrolytic stability test ... 20
Annex D (normative) Photostability test ... 23
Annex E (normative) Nd-YAG laser exposure test ... 25
Annex F (informative) Supplemental conditions of test for local effects after
implantation ... 27
Annex G (normative) Ocular implantation test ... 28
Annex NA (informative) Technical differences between this Standard and ISO 11979-
5:2006 and their reasons ... 33
Bibliography ... 35
Ophthalmic implants - Intraocular lenses - Part 5:
Biocompatibility
1 Scope
This Part of YY 0290 specifies particular requirements for the biocompatibility
evaluation of materials for intraocular lenses (IOL) including the processing conditions
to produce them. These requirements include evaluation of physicochemical properties
that are relevant to biocompatibility. It also gives guidance on conducting an ocular
implantation test.
2 Normative references
The provisions in following documents become the provisions of this Part of YY 0290
through reference in this Part. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Part, however, parties who
reach an agreement based on this Part are encouraged to study if the latest versions of
these documents are applicable. For undated references, the latest edition of the
referenced document applies.
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (GB/T 16886.1-2001, idt ISO 10993-
1:1997)
GB/T 16886.2, Biological evaluation of medical devices - Part 2: Animal welfare
requirements (GB/T 16886.2-2000, idt ISO 10993-2:1992)
GB/T 16886.3, Biological evaluation of medical devices - Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity (GB/T 16886.3-2003, ISO
10993-3:2003, IDT)
GB/T16886.6, Biological evaluation of medical devices - Part 6: Tests for local
effects after implantation (GB/T 16886.6-1997, idt ISO 10993-6:1994)
GB/T 16886.10, Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization (GB/T 16886.10-2005, ISO 10993-10:2002, IDT)
GB/T 16886.12, Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials (GB/T 16886.12-2002, idt ISO 10993-12:2002)
YY 0290.1, Ophthalmic implants - Intraocular lenses - Part 1: Terminology (YY
0290.1-2008, ISO 11979-1:2006, MOD)
YY 0290.2, Ophthalmic optics - Intraocular lenses - Part 2: Optical properties and
test methods
YY 0290.3, Ophthalmic optics - Intraocular lenses - Part 3: Mechanical properties
and test methods (YY 0290.3-2008, ISO 11979-3:2006, IDT)
YY/T 0316, Medical devices - Application of risk management to medical devices
(YY/T 0316-2003, ISO 14971:2000, IDT)
ISO 10339, Ophthalmic optics - Contact lenses - Determination of water content of
hydrogel lenses
3 Terms and definitions
For the purposes of this Part of YY 0290, the terms and definitions defined in YY 0290.1
apply.
4 General requirements applying to biocompatibility
evaluation of intraocular lenses
The evaluation of the biocompatibility of the test material shall start with an initial
assessment of risk in accordance with YY/T 0316. The physicochemical tests described
in Clause 5 shall first be considered. The evaluation of the material for biological safety
shall then be undertaken in accordance with the principles and requirements of GB/T
16886.1 and GB/T 16886.2, taking into consideration the results from the
physicochemical tests.
Furthermore, the risk assessment shall include an assessment of the potential for
material changes such as calcification. This risk assessment shall consider the history
of clinical use of the material, and animal models to test the long-term stability of the
material.
Carry out the biocompatibility testing in accordance with GB/T 16886.1, GB/T 16886.3,
GB/T 16886.5, GB/T 16886.6, GB/T 16886.10 and as noted in this Part.
The pre-existing information on the material and all the information obtained in the
evaluation process shall be integrated in an overall risk benefit assessment in
accordance with YY/T 0316.
5 Physicochemical tests
5.1 General
5.1.1 The following physicochemical tests shall be considered:
a) exhaustive extraction;
b) leachables;
c) hydrolytic stability;
d) photostability;
e) stability against Nd-YAG laser exposure;
f) insoluble inorganics.
5.1.2 The objectives of this group of tests are:
a) to quantify possible residues from synthesis and additives or impurities from
manufacturing and packaging;
b) to quantify possible degradation products due to hydrolysis;
c) to quantify leachable chemical components;
d) to facilitate an analysis of any risks introduced by toxic products which may result
from processing, treatment in use, or ageing of the test material.
5.1.3 The results of the tests given in 5.1.1 and 5.1.2 shall be recorded and included in
the assessment for risk in accordance with YY/T 0316. If any of the above tests was not
performed, a rationale justifying this decision shall be documented.
5.2 Exhaustive extraction test
The test material shall be tested for extractables under exhaustive extraction conditions
in accordance with the method described in Annex A, which describes several
extraction conditions, including the extraction media, temperature and duration.
Alternate methods can be used provided that they have been validated.
The following shall be considered:
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 extractable components of the material, such as process
contaminants, residual monomers, additives, and other extractable components.
To - the temperature of the inside of the eye (35°C).
c) Before and after the test, the test material shall be inspected under an optical
microscope with a power of not less than 10 times. Compared with the untreated
material, there shall be no obvious difference on the outer surface, such as air
bubbles, dendrites, cracks;
d) Before and after the test, the test material shall be tested and recorded for the
spectral transmittance in the ultraviolet and visible light bands. By comparing the
spectral transmittance diagrams, the spectral transmittance of the test material
does not change significantly before and after the test. If a finished intraocular
lens (IOL) is used for the test, its optical power and image quality shall be
measured before and after the test. The focal power and image quality of the test
material before and after the test shall not change significantly (for a 20D
intraocular lens, it is ±0.25D).
According to the above results, risk assessment shall be carried out on the potential
hazards caused by the instability of the test materials in the water environment, and
records shall be made.
NOTE: Qualitative and quantitative analysis of degradation products in the immersion medium can
be performed if desired.
5.5 Photostability test
Photostability test shall be conducted in accordance with Annex D.
For anterior chamber intraocular lenses, the mechanical properties of the irradiated and
unirradiated test materials did not change significantly.
No significant change shall be detected between the UV/Vis spectra of the test material
exposed to UV radiation and controls receiving no radiation.
NOTE 1: The loops of implanted anterior chamber IOLs are exposed to radiation, hence the rationale
for requiring mechanical testing after irradiation.
NOTE 2: The following parameters have been found to be relevant to in situ exposure of an IOL to
UV radiation:
a) When simulating the radiation intensity of ultraviolet radiation with a wavelength of
300nm~400nm in the eye, under the condition of diffuse light at the intraocular lens (I1):
0.3mW/cm2.
It is internationally recognized that in the solar radiation area near the Tropic of Cancer, the
estimated value of the entire intensity of sunlight is 1kW/m2=100mW/cm2 on average. The
near-ultraviolet wavelength part of 300nm ~ 400nm is about 6.5% of the full intensity, which
is 6.5mW/cm2. When the intraocular lens is exposed to sunlight that reaches the back of the
cornea and aqueous humor, in the solar spectrum, part of the near-ultraviolet radiation is not
and requirements of GB/T 16886.1 taking into consideration the results of the
physicochemical tests. The following biological endpoints shall be considered:
- effects on cell growth and cell damage;
- genotoxicity;
- local effects after implantation;
- sensitization potential.
Where testing is deemed necessary, the appropriate parts of GB/T 16886 shall apply.
Supplements to these parts are described in 6.2 and 6.3 of this Part. Sample preparation
shall be performed in accordance with GB/T 16886.12 taking into consideration the
supplemental requirements. In addition, an ocular implantation test shall also be
considered in accordance with 6.4.
If the risk assessment has identified the potential for material change when exposed to
an in vivo environment, a test shall be performed to assess the reciprocal tolerance of
the test material and local tissue. An example of such a test is the test for local effects
after implantation as described in GB/T 16886.6 supplemented as indicated in Annex F
of this document.
6.2 Tests for genotoxicity
Testing for genotoxicity shall be performed in accordance with GB/T 16886.3
supplemented with the following:
- Two separate extractions of the material shall be performed, one with
physiological saline, and the other with a lipophilic or dipolar solvent. The
lipophilic or dipolar solvent shall not dissolve or degrade the material.
- Extraction shall be performed with agitation at 37°C ± 2°C for 72 h ± 2 h at a
ratio of 1g of material per 10mL of extracting medium.
6.3 Tests for sensitization
Testing for sensitization shall be performed in accordance with GB/T 16886.10
supplemented with the following.
- Either the maximization sensitization test or the local lymph node assay (LLNA)
can be used for testing.
- The test material shall be extracted with two different extractants, one of which is
physiological saline, and the second a lipophilic or dipolar solvent. The lipophilic
or dipolar solvent shall not dissolve or degrade the test material.
The solvent itself shall also not be a known irritant, adjuvant or sensitizer.
Annex A
(normative)
Exhaustive extraction test
A.1 Purpose
The purpose of this test is to detect and quantify extractable additives and other
leachables from intraocular lens material under exhaustive extraction conditions.
A.2 General considerations
Select an established and validated analytical method that meets the detection limit of
the concentration determination.
A.3 Principle
The method of extraction described in this annex employs the normal Soxhlet apparatus.
This annex also describes the particular precautions necessary when handling
intraocular lenses; it also gives guidance on the range of solvents that may be employed.
In selecting the solvent, give consideration to the ability of the solvent to swell the
material to enable extraction without destroying the polymeric structure or dissolving
the material and the solubility of the potential residual monomers in the solvent to
obtain complete extraction. Use water or a suitable organic solvent for the extraction.
Extraction of some materials such as hydrophilic IOLs can require both aqueous and
organic solvent extraction to insure extraction of both hydrophilic (salts) and
hydrophobic components (monomers, UV absorbers, etc.).
Substances extracted from intraocular lenses: residual monomers, crosslinks, catalysts,
shall be detected by chromatographic, spectrophotometric and wet analysis methods.
The following method can be utilized when the solvent swells the test material enough
to ensure complete extraction.
A.4 Test samples
Sterile finished IOLs weighing no less than 200mg.
A.5 Reagents
A.5.1 Water: distilled or deionized.
A.5.2 Organic solvent: analytically pure or purer.
A.5.3 Boiling stones or anti-bumping granules.
A.5.4 Active desiccant.
A.6 Apparatus
The following list is advisory. Other suitable means can be used.
A.6.1 Soxhlet extraction apparatus, including condenser, round-bottom flask and
heating mantle with glass components of standard borosilicate laboratory glassware.
A.6.2 Extraction thimble, made from perforated stainless steel, sintered glass, paper or
equivalent, fitted with a glass wool plug or other suitable closure.
A.6.3 Drying apparatus, vacuum oven, or other suitable drying apparatus.
A.6.4 Analytical balance, precise to 0.1mg or better.
A.6.5 High-pressure liquid chromatography (HPLC).
A.6.6 Gas chromatography (GC).
A.6.7 Gas chromatography/mass spectroscopy (GC/MS).
A.7 Test procedure
WARNING: When using a volatile or flam...