YY/T 0290.5-2023 English PDF (YY/T0290.5-2023)

YY/T 0290.5-2023: Ophthalmic optics - Intraocular lenses - Part 5: Biocompatibility
Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY/T 0290.5-2023 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 0290.5-2023
Preview True-PDF (Reload/Scroll-down if blank)


YY/T 0290.5-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
CCS C 40
Replacing YY/T 0290.5-2008
Ophthalmic optics -- Intraocular lenses -- Part 5:
Biocompatibility
(ISO 11979-5:2020, Ophthalmic implants -- Intraocular lenses -- Part 5:
Biocompatibility, MOD)
ISSUED ON: SEPTEMBER 05, 2023
IMPLEMENTED ON: SEPTEMBER 15, 2024
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 7
2 Normative references ... 7
3 Terms and definitions ... 8
4 General requirements applying to biocompatibility evaluation of intraocular lenses 8
5 Physicochemical tests ... 9
6 Biological tests ... 14
Annex A (normative) Exhaustive extraction test ... 17
Annex B (normative) Test for leachables ... 22
Annex C (informative) Hydrolytic stability ... 25
Annex D (normative) Photostability test ... 29
Annex E (normative) Nd-YAG laser exposure test ... 32
Annex F (normative) Supplemental conditions of test for local effects after implantation
... 34
Annex G (normative) Ocular implantation test ... 36
Bibliography ... 41
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020
"Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents".
This document is Part 5 of YY/T 0290 "Ophthalmic optics -- Intraocular lenses". The
following parts of YY/T 0290 have been published:
- Part 1: Terminology;
- Part 2: Optical properties and test methods;
- Part 3: Mechanical properties and test methods;
- Part 4: Labeling and information;
- Part 5: Biocompatibility;
- Part 6: Shelf life and transportation stability;
- Part 8: Fundamental requirement;
- Part 9: Multifocal intraocular lenses;
- Part 10: Phakic intraocular lenses.
This document replaces YY/T 0290.5-2008 "Ophthalmic implants -- Intraocular lenses
-- Part 5: Biocompatibility". Compared with YY/T 0290.5-2008, in addition to
structural adjustments and editorial changes, the main technical changes are as follows:
- Added Table 1 and Table 2 (see Chapter 4 of this Edition);
- Changed the overview of physical and chemical tests (see 5.1 of this Edition; 5.1
of Edition 2008);
- Added physical/chemical description (see 5.2 of this Edition);
- Changed the limit extraction test (see 5.3, Annex A of this Edition; 5.2, Annex A of
Edition 2008);
- Changed the hydrolysis stability test (see 5.5, Annex C of this Edition; 5.4, Annex
C of Edition 2008);
- Changed the light stability test (see 5.6, Annex D of this Edition; 5.5, Annex D of
Edition 2008);
- Changed the Nd-YAG laser irradiation test (see 5.7, Annex E of this Edition; 5.6,
Ophthalmic optics -- Intraocular lenses -- Part 5:
Biocompatibility
1 Scope
This document specifies the specific requirements for the biocompatibility evaluation
of intraocular lenses (Translator NOTE: it is referred as IOLs), including the
biocompatibility evaluation requirements of materials under production process
conditions, the evaluation of physicochemical properties related to biocompatibility,
and the test methods for ocular implantation.
This document applies to intraocular lenses.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 11417.7, Ophthalmic optics -- Contact lenses -- Part 7: Physicochemical
properties test methods
GB/T16886.1, Biological evaluation of medical devices -- Part 1: Evaluation and
testing within a risk management process (GB/T 16886.1-2022, ISO10993-1:2018,
IDT)
GB/T 16886.2, Biological evaluation of medical devices -- Part 2: Animal welfare
requirements (GB/T 16886.2-2011, ISO 10993-2:2006, IDT)
GB/T 16886.3, Biological evaluation of medical devices -- Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity (GB/T 16886.3-2019, ISO
10993-3:2014, IDT)
GB/T 16886.5, Biological evaluation of medical devices -- Part 5: Tests for in vitro
cytotoxicity (GB/T 16886.5-2017, ISO 10993-5 :2019, IDT)
GB/T 16886.6, Biological evaluation of medical devices -- Part 6: Tests for local
effects after implantation (GB/T 16886.6-2022, ISO 10993-6:2016, IDT)
GB/T 16886.10, Biological evaluation of medical devices -- Part 10: Tests for skin
sensitization (GB/T 16886.10-2017, ISO 10993-10:2010, IDT)
GB/T 16886.12, Biological evaluation of medical devices -- Part 12: Sample
B.5.8 High-pressure liquid chromatograph (HPLC).
B.5.9 Gas chromatograph/Mass spectroscope (GC/MS).
B.5.10 UV/visible (UV/Vis) spectrophotometer.
B.6 Test procedure
B.6.1 Extraction
Choose two different extraction media, one aqueous and one lipophilic solvent, selected
with relevance to the test material.
Divide the test material into two equal parts for incubation in the two extraction media.
Determine the mass of each part.
Place the test material in glass vials containing a sufficient volume of medium to
achieve a ratio of 10 g of test material per 100 ml of medium. Use at least two vials for
each medium. Agitate to ensure that all surfaces of the test material are available for
extraction during the entire period of extraction.
Extract the test material at 35°C±2°C for 72 h ± 1 h.
B.6.2 Analysis of extracts
Remove the vials from the incubator and allow them to equilibrate at room temperature.
Remove the test material from the vials and examine them as specified in B.6.3.
Perform qualitative and quantitative analyses for leachable substances such as UV-
absorbers, additives, and degradation products by HPLC, GC/MS, and/or UV/Vis
spectrophotometry as appropriate. Analyse the extract in each vial separately.
Carry out the corresponding qualitative and quantitative analyses on solvent blanks that
have undergone the same treatment.
Compare the results of the qualitative and quantitative analyses of the extracts of the
test material to those of the solvent blank.
B.6.3 Analysis of the test material
Take at random five pieces of test material from each extraction condition and
determine their spectral transmittance as described in YY 0290.2. Compare the
transmittance spectra of the treated test material with spectra of the untreated material,
and record any changes.
B.7 Test report
The test report shall include the following at a minimum:
a) all information necessary for identification of the samples tested;
YY/T 0290.5-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
CCS C 40
Replacing YY/T 0290.5-2008
Ophthalmic optics -- Intraocular lenses -- Part 5:
Biocompatibility
(ISO 11979-5:2020, Ophthalmic implants -- Intraocular lenses -- Part 5:
Biocompatibility, MOD)
ISSUED ON: SEPTEMBER 05, 2023
IMPLEMENTED ON: SEPTEMBER 15, 2024
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 7
2 Normative references ... 7
3 Terms and definitions ... 8
4 General requirements applying to biocompatibility evaluation of intraocular lenses 8
5 Physicochemical tests ... 9
6 Biological tests ... 14
Annex A (normative) Exhaustive extraction test ... 17
Annex B (normative) Test for leachables ... 22
Annex C (informative) Hydrolytic stability ... 25
Annex D (normative) Photostability test ... 29
Annex E (normative) Nd-YAG laser exposure test ... 32
Annex F (normative) Supplemental conditions of test for local effects after implantation
... 34
Annex G (normative) Ocular implantation test ... 36
Bibliography ... 41
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020
"Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents".
This document is Part 5 of YY/T 0290 "Ophthalmic optics -- Intraocular lenses". The
following parts of YY/T 0290 have been published:
- Part 1: Terminology;
- Part 2: Optical properties and test methods;
- Part 3: Mechanical properties and test methods;
- Part 4: Labeling and information;
- Part 5: Biocompatibility;
- Part 6: Shelf life and transportation stability;
- Part 8: Fundamental requirement;
- Part 9: Multifocal intraocular lenses;
- Part 10: Phakic intraocular lenses.
This document replaces YY/T 0290.5-2008 "Ophthalmic implants -- Intraocular lenses
-- Part 5: Biocompatibility". Compared with YY/T 0290.5-2008, in addition to
structural adjustments and editorial changes, the main technical changes are as follows:
- Added Table 1 and Table 2 (see Chapter 4 of this Edition);
- Changed the overview of physical and chemical tests (see 5.1 of this Edition; 5.1
of Edition 2008);
- Added physical/chemical description (see 5.2 of this Edition);
- Changed the limit extraction test (see 5.3, Annex A of this Edition; 5.2, Annex A of
Edition 2008);
- Changed the hydrolysis stability test (see 5.5, Annex C of this Edition; 5.4, Annex
C of Edition 2008);
- Changed the light stability test (see 5.6, Annex D of this Edition; 5.5, Annex D of
Edition 2008);
- Changed the Nd-YAG laser irradiation test (see 5.7, Annex E of this Edition; 5.6,
Ophthalmic optics -- Intraocular lenses -- Part 5:
Biocompatibility
1 Scope
This document specifies the specific requirements for the biocompatibility evaluation
of intraocular lenses (Translator NOTE: it is referred as IOLs), including the
biocompatibility evaluation requirements of materials under production process
conditions, the evaluation of physicochemical properties related to biocompatibility,
and the test methods for ocular implantation.
This document applies to intraocular lenses.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 11417.7, Ophthalmic optics -- Contact lenses -- Part 7: Physicochemical
properties test methods
GB/T16886.1, Biological evaluation of medical devices -- Part 1: Evaluation and
testing within a risk management process (GB/T 16886.1-2022, ISO10993-1:2018,
IDT)
GB/T 16886.2, Biological evaluation of medical devices -- Part 2: Animal welfare
requirements (GB/T 16886.2-2011, ISO 10993-2:2006, IDT)
GB/T 16886.3, Biological evaluation of medical devices -- Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity (GB/T 16886.3-2019, ISO
10993-3:2014, IDT)
GB/T 16886.5, Biological evaluation of medical devices -- Part 5: Tests for in vitro
cytotoxicity (GB/T 16886.5-2017, ISO 10993-5 :2019, IDT)
GB/T 16886.6, Biological evaluation of medical devices -- Part 6: Tests for local
effects after implantation (GB/T 16886.6-2022, ISO 10993-6:2016, IDT)
GB/T 16886.10, Biological evaluation of medical devices -- Part 10: Tests for skin
sensitization (GB/T 16886.10-2017, ISO 10993-10:2010, IDT)
GB/T 16886.12, Biological evaluation of medical devices -- Part 12: Sample
B.5.8 High-pressure liquid chromatograph (HPLC).
B.5.9 Gas chromatograph/Mass spectroscope (GC/MS).
B.5.10 UV/visible (UV/Vis) spectrophotometer.
B.6 Test procedure
B.6.1 Extraction
Choose two different extraction media, one aqueous and one lipophilic solvent, selected
with relevance to the test material.
Divide the test material into two equal parts for incubation in the two extraction media.
Determine the mass of each part.
Place the test material in glass vials containing a sufficient volume of medium to
achieve a ratio of 10 g of test material per 100 ml of medium. Use at least two vials for
each medium. Agitate to ensure that all surfaces of the test material are available for
extraction during the entire period of extraction.
Extract the test material at 35°C±2°C for 72 h ± 1 h.
B.6.2 Analysis of extracts
Remove the vials from the incubator and allow them to equilibrate at room temperature.
Remove the test material from the vials and examine them as specified in B.6.3.
Perform qualitative and quantitative analyses for leachable substances such as UV-
absorbers, additives, and degradation products by HPLC, GC/MS, and/or UV/Vis
spectrophotometry as appropriate. Analyse the extract in each vial separately.
Carry out the corresponding qualitative and quantitative analyses on solvent blanks that
have undergone the same treatment.
Compare the results of the qualitative and quantitative analyses of the extracts of the
test material to those of the solvent blank.
B.6.3 Analysis of the test material
Take at random five pieces of test material from each extraction condition and
determine their spectral transmittance as described in YY 0290.2. Compare the
transmittance spectra of the treated test material with spectra of the untreated material,
and record any changes.
B.7 Test report
The test report shall include the following at a minimum:
a) all information necessary for identification of the samples tested;