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YY 0766-2009Lens ultrasonic removal and vitrectomy devices for ophthalmic surgery (English PDF)

眼科晶状体超声摘除和玻璃体切除设备

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 30, 2009

Implementation date

June 1, 2011

Scope

YY 0766-2009 is the English-translated version of 眼科晶状体超声摘除和玻璃体切除设备.

YY 0766-2009 is the Chinese pharmaceutical industry standard for the lens ultrasonic removal and vitrectomy device used in ophthalmic surgery, the console and handpieces with which the cataractous lens is emulsified and aspirated and the vitreous is cut and removed.

It specifies the terms and definitions, the classification of the products, the requirements and the test methods, covering the ultrasonic frequency and the tip stroke, the aspiration flow and vacuum and their accuracy, the irrigation, the cutting rate of the vitrectomy probe, the alarms and the foot control, and the electrical safety. Issued on 30 December 2009, it has applied since 1 June 2011.

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Document preview — YY 0766-2009

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
1 Scope4
2 Normative References4
3 Terms and Definitions5
4 Product Classification6
5 Requirements7
6 Test Methods10

Foreword

This Standard's entire technical contents are mandatory.

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 Mohm 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. […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

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