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YY 0762-2009 (YY0762-2009)

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YY 0762-2009: PDF in English
YY 0762-2009
ICS 11.040.70
C 40
Pharmaceutical Industry Standard
of the People’s Republic of China
Ophthalmic optics
Capsular tension ring
眼科光学囊袋张力环
Issued on December 30, 2009 Implemented on June 1, 2011
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and Definitions... 5
4 Requirements ... 6
5 Testing Methods... 9
6 Signs and Instructions for Use ... 11
7 Packaging, Transportation and Storage ... 12
References and Original Chinese Documents ... 13
Foreword
The performance requirements of this Standard are developed by basing on the
product clinical requirements and referring to the YY 0290 series of standards.
Biocompatibility requirements of this Standard shall be determined by referring to
GB/T16886.1 Evaluation of Medical Devices Biology Part 1. Guide of Select Test.
This Standard is approved by the State Food and Drug Administration.
This Standard is proposed and administered by National Medical Optical Instrument
Standardization Technical Committee (SAC/TC 103/SC1).
This Standard is drafted by organizations. Hangzhou Medical Device Quality
Supervision and Inspection Center of State Food and Drug Administration.
This Standard is mainly drafted by. Wen Yan, Jia Hang, and Feng Qin.
Ophthalmic optics -- Capsular tension ring
1 Scope
This Standard specifies the scope, requirements, test methods, marking and
instructions, packaging, transportation and storage of capsular tension ring.
This Standard applies to one-time use of capsular tension ring (hereinafter referred
to as “the tension ring”). Tension ring is for aphakia to maintain capsular tension, and
prevents posterior capsular from wrinkle, and is also used against the capsular bag
from contraction.
2 Normative references
The following normative documents contain provisions which, through reference in the
text, constitute provisions of this Standard. For dated reference, subsequent
amendments to, or revisions of, any of these publications (excluding contents of
corrigenda) do not apply. However, parties who enter into agreements based on this
Standard are encouraged to investigate the possibility of applying the most recent
editions of the Standards indicated below. For undated references, the latest edition
of the normative document referred to applies.
GB/T 191 Packaging-Pictorial marking for handling of goods
GB 9969.1 Instructions of industrial products – General Principles
GB/T 16886.1 Evaluation of Medical Devices Biology Part 1. Evaluation and Testing
(ISO 10993.1.1997, IDT)
GB/T 16886.5 Evaluation of Medical Devices Biology Part 5. The Test of Vitro
Cytotoxicity (ISO 10993.5.1999, IDT)
GB/T 16886.6 Evaluation of Medical Devices Biology Part 6. The Test of Local
Reactions after Implanting (ISO 10993.6.1994, IDT)
GB/T 16886.7 Evaluation of Medical Devices Biology Part 6. The Amount of Ethylene
Oxide Sterilization Residuals (ISO 10993.7.1995 IDT)
5 Testing Methods
5.1 Test of Mechanical Properties
5.1.1 Functional Stretch Test
5.1.1.1 Tolerance of Nominal Value of Functional Stretch
Instrument. Minimal reading of micro-force meter is. mN.
Steps. SAMPLE 3 tension rings. PLACE the samples on the fixture of the micro-force
meter. The fixture may use the device of Appendix A of YY 0290.3. ADJUST the
samples to make the outer force-point to be symmetric. Then IMMERSE the fixture in
the 35ºC physiological salt solution. Under the state of the tension ring is not
deformed, the meter’s reading shall be reset to zero. ADJUST the shifter to make the
tension ring meet the requirements of position-shift. READ the value on the meter.
REPEAT the tests 3 times and GET the arithmetic mean.
5.1.1.2 Functional Stretch Attenuation
a) The ratio test of functional stretch attenuation shall be conducted and based on
5.1.1.1.1. CALCULATE the functional stretch attenuation and the ratio of functional
stretch.
b) The ratio test of the deformation of the total diameter. SELECT 3 tension rings,
MEASURE total diameter of the respective tension rings and RECORD the
corresponding measuring points. PLACE the tension rings inside the device of
Appendix F of YY 0290.3 and IMMERSE them in container with salt solution. Then
IMMERSE the container into the 35ºC water bath and MAINTAIN for 24h. REMOVE
them carefully and immediately MEASURE the total diameter of tension rings.
CALCULATE the ratio of deformation and compression.
5.1.2 Deformation and Stress Measurement
Instrument. USE projector to measure
Environment. 23ºC to 5ºC.
Steps.
a) SAMPLE 3 tension rings, MEASURE and RECORD the total diameter.
COMPRESS samples as required and MAINTAIN for 3 minutes. After Restoring for
5.5.3 Test of Delayed-type Hypersensitivity
CONDUCT the test according to the methods in GB/T 16886.10. The results shall be
consistent with the regulations in 4.5.3.
5.5.4 Test of Ocular and Non-Ocular Implantation
CONDUCT the test according to the methods in GB/T 16886.6. The results shall be
consistent with the regulations in 4.5.4.
5.6 Test of Sterilization
5.6.1 Test of sterilization shall be conducted according to the methods in GB/T
14233.2. The results shall be consistent with the regulations in 4.6.1.
5.6.2 The test of residual ethylene oxide shall be conducted according to the methods
in GB/T 14233.1. The results shall be consistent with the regulations in 4.6.2.
5.7 Test of Packaging Integrity
Inspected with eyes and unpacking inspection - The results shall be consistent with
the regulations in 4.7.
5.8 Test of Validity
CONDUCT the test according to the methods in YY 0290.6. TEST each testing point
according to 4.2, 4.3, 4.6 and 4.7. The results shall be consistent with the
requirements in 4.8.
6 Signs and Instructions for Use
6.1 The storage container of tension ring shall have the following contents.
a) Name of manufacturer, logo or trade name;
b) Manufacturer’s address;
c) Product name of tension ring (including possible product number);
d) Product lot number or production date;
e) Words of "Sterilization";
f) Expiration date – expressed in year and month (symbol expression may be used);
g) The appearance drawing of tension ring.
6.2 Instructions for use shall be consistent with the regulations in GB 9969.1-1998
References and Original Chinese Documents
[1] YY 0762-2009 Ophthalmic optics Capsular tension ring.
......
(Above excerpt was released on 2014-03-17, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YY0762-2009