YY 0766-2009 PDF English
US$140.00 · In stock · Download in 9 secondsYY 0766-2009: Lens ultrasonic removal and vitrectomy devices for ophthalmic surgery Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0766-2009 | English | 140 |
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Lens ultrasonic removal and vitrectomy devices for ophthalmic surgery
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YY 0766-2009: Lens ultrasonic removal and vitrectomy devices for ophthalmic surgery---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0766-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.70
C 41
Lens Ultrasonic Removal and
Vitrectomy Device for Ophthalmic Surgery
Issued on. DECEMBER 30, 2009
Implemented on. JUNE 1, 2011
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Terms and Definitions... 5
4 Product Classification... 6
5 Requirements... 7
6 Test Methods... 10
Foreword
This Standard’s entire technical contents are mandatory.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of Subcommittee for Medical Ultrasonic
Device Standardization of National Technical Committee for Standardization of
Medical Apparatus (SAC/TC10/SC2).
Drafting organizations of this Standard. Hubei Center of Medical Device Quality,
Supervision and Testing of State Food and Drug Administration, Alcon (China)
Ophthalmic Product Co., Ltd., and Tianjin Maida Medical Science And Technology Co.,
Ltd..
Chief drafting staffs of this Standard. Mang Anshi, Lu Lu, Wang Zhijian, Wang Yanqun,
Zhang Yusheng, and Jiang Shilin.
Lens Ultrasonic Removal and
Vitrectomy Device for Ophthalmic Surgery
1 Scope
This Standard specifies the terms and definitions, product classification, requirements
and test methods of lens ultrasonic removal and vitrectomy device for ophthalmic
surgery.
This Standard is applicable to the lens ultrasonic removal device for ophthalmic
surgery (hereinafter refers to device), which also possesses the vitrectomy function.
NOTE. Phacofragmentation of lens indicates, in the earliest period, the surgery to use
ultrasonic energy to crush (or emulsify) cataract lens, and extract lens tissues through small
incision; currently, ultrasound is still the most important means for the lens removal and
vitrectomy device for ophthalmic surgery; recently, there are the device using other energy and
extracting cataract lens through small incision (such as laser and liquefaction); for which this
Standard can be referred to.
2 Normative References
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Standard, however, parties
who reach an agreement based on this Standard 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 9706.1 Medical Electrical Equipment - Part 1.General Requirements for
Safety (IEC 60601-1.1988, IDT)
GB 9706.15 Medical Electrical Equipment - Part 1-1.General Requirements for
Safety - Collateral Standard. Safety Requirements for Medical Electrical Systems
(IEC 60601-1-1.2000, IDT)
3 Terms and Definitions
The following terms and definitions are applicable to this Standard.
3.1 Aspiration
Use a pipette to draw liquid or gas from the eye.
3.2 Diathermy
The surgical method to use High-Frequency (HF) current to block blood vessels or
other tissues.
3.3 Drain container
A sealed container (bottle or bag) for collecting the drawn or aspirated liquid.
3.4 Handpiece (Probe)
A handpiece for mounting a tip portion, and serving for lens removal and vitrectomy.
3.5 Lens removal
Remove the useless lens tissues.
4 Product Classification
The devices are divided into the following ones as per their intended use.
5 Requirements
5.1 Static irrigation pressure
5.1.1 Maximum static irrigation pressure
The actual output maximum static irrigation pressure shall not exceed 26.7 kPa (200
mmHg).
5.2 Aspiration vacuum degree
5.2.1 Maximum aspiration vacuum degree
Compared with the ambient atmospheric pressure, the relative aspiration vacuum
degree (negative pressure) shall not exceed 100 kPa (750 mmHg).
5.3 Tip ultrasonic vibration of lens removal
5.3.1 Accuracy of tip vibration speed
For all types of tips listed in the instruction manual, ultrasonic vibration speed shall
conform to the manufacturer’s specified nominal value, the deviation shall not exceed
± 20%.
5.4 Vitrectomy
The device with vitrectomy function shall conform to the following requirements.
5.5 Coagulation
If the device is equipped with coagulation function, it shall conform to the following
requirements.
5.5.1 Frequency of coagulation
The deviation between coagulation output frequency and the nominal frequency shall
not exceed ± 20%; while the frequency range shall be between 0.01 MHz and 15
MHz.
IF the device is equipped with illumination function against the eye during the surgery
period, it shall conform to the following requirements.
5.6.1 Accuracy of illumination output
If illumination output provides the setting function between the maximum value and
20% or other lower value (take the larger one between the two); the deviation
between actual illumination output and the device displayed illumination value or the
setting value shall not exceed ± 25%.
5.6.2 Limit of illumination output intensity
When testing at a distance of 5 mm from the optical fiber outlet, the illumination light
intensity shall conform to the following requirements in 4.2 of ISO 15752.2000.
5.7 Safety Requirements
5.7.1 General safety of the device
It shall conform to the requirements of GB 9706.1.If the device belongs to medical
electrical system, it shall also conform to the requirements of GB 9706.15.
6 Test Methods
6.1 Static irrigation pressure
6.1.1 Test method of gravity irrigation device
The following test method shall be taken.
6.4 Vitrectomy tip speed
6.4.1 Accuracy of vitrectomy tip speed
Method I. Use stroboscopic instrument to measure
6.4.2 Lowest speed of vitrectomy tip
In addition to the single-cutting mode, any cutting speed under any setting
background measured by the above method shall conform to the requirements of
5.4.2.
6.5 Coagulation function
6.5.1 Coagulation frequency
Use oscilloscope or frequency meter, test by the probe with 100 times of ultrasonic
frequency and 100 MΩ high impedance in the two loading ends, which shall conform
to the requirements of 5.5.1.
6.6 Illumination function
6.6.1 Accuracy of illumination output
The following test method shall be taken.
6.6.2 Illumination output intensity
Measure, at a distance about 5 mm from the optical fiber outlet, as per the method
and instrument specified in Clause 5 and Appendix C of ISO 15752.2000, which shall
conform the requirements of 5.6.2.
6.7 Safety requirements
6.7.1 General safety requirements shall be met as per the methods specified in GB
9706.1 and GB 9706.15.
6.7.2 Special safety requirements shall be met as per the method specified in the
corresponding standard.
6.8 Instruction manual
It shall be verified through checking the instruction manual.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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