YY 0290.2-2009 (YY 0290.2-2021 Newer Version) PDF English
Search result: YY 0290.2-2009 (YY 0290.2-2021 Newer Version)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YY 0290.2-2021 | English | 410 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Ophthalmic optics -- Intraocular lenses -- Part 2: Optical properties and test methods
| Valid |
| YY 0290.2-2009 | English | 305 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Ophthalmic implants. Intraocular lenses. Part 2: Optical properties and test methods
| Obsolete |
| YY 0290.2-1997 | English | 519 |
Add to Cart
|
4 days
|
Intraocular lenses. Part 2: Optical properties and their test methods
| Obsolete |
BUY with any currencies (Euro, JPY, GBP, KRW etc.): YY 0290.2-2021 Newer version: YY 0290.2-2021
PDF Preview: YY 0290.2-2021
PDF Preview: YY 0290.2-2009
YY 0290.2-2009: PDF in English YY 0290.2-2009
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Replacing YY 0290.2-1997
Ophthalmic implants - Intraocular lenses - Part 2: Optical
properties and test methods
(ISO 11979-2:1999, MOD)
ISSUED ON: JUNE 16, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 Requirements ... 6
Annex A (normative) Measurement of dioptric power ... 11
Annex B (normative) Measurement of resolution efficiency ... 18
Annex C (normative) Measurement of modulation transfer function (MTF) ... 21
Annex D (informative) Precision of dioptric power determination ... 25
Annex E (informative) Precision of imaging quality determination ... 26
Annex F (informative) Verification of ray trace calculations ... 27
Annex G (informative) Selected definitions ... 28
Annex H (informative) Blue light hazard function B(λ) data ... 29
Foreword
YY 0290 “Ophthalmic implants - Intraocular lenses” consists of the following 9 parts:
- 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 transport stability;
- Part 8: Fundamental requirement;
- Part 9: Multifocal intraocular lenses;
- Part 10: Phakic intraocular lenses.
This is Part 2 of YY 0290.
The revision of this Part adopts ISO 11979-2:1999 “Ophthalmic implants - Intraocular
lenses - Part 2: Optical properties and test methods” and TECHNICAL
CORRIGENDUM 1.
The main differences between this Part and ISO 11979-2:1999 are as follows:
- In Chapter 2 “Normative references”, use Chinese standards as references. Delete
ISO 6328 and U.S. Mil Std 150-A-1961 that are not cited in the main text and
have no corresponding Chinese national standards;
- For the spectral transmittance of 4.4, add the UV limit requirements and related
requirements for blue light attenuating intraocular lenses;
- Supplement the provisions on test methods for 4.4 Spectral transmittance.
This Part replaces YY 0290.2-1997 “Intraocular lenses. Part 2: Optical properties and
their test methods”.
The main differences between this Part and YY 0290.2-1997 are as follows:
- Delete the requirements for astigmatism in 4.2 of YY 0290.2-1997;
- Supplement the requirements for 4.3 Imaging quality;
- In 4.4 Spectral transmittance, add UV limit requirements and requirements related
Ophthalmic implants - Intraocular lenses - Part 2: Optical
properties and test methods
1 Scope
This Part of YY 0290 specifies requirements and test methods for certain optical
properties of intraocular lenses ((IOLs).
This Part is applicable to non-toric, monofocal intraocular lenses intended for
implantation into the anterior segment of the human eye.
This document does not include corneal implants.
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 4315.1, Optical transfer function - Part 1: Terminology and symbol
GB/T 4315.2, Optical transfer function - Part 2: Directives of measurement
YY 0290.1, Ophthalmic implants. Intraocular lenses. Part 1: Terminology (YY
0290.1-2008, idt ISO 11979-1:2006)
3 Terms and definitions
For the purposes of this Part of YY 0290, the terms and definitions defined in YY 0290.1
and GB/T 4315.1 apply.
4 Requirements
4.1 General
All requirements stated below shall apply to the finished products. If applicable, the
lens shall be positioned as intended for use.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
|