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YY 0849-2011Ophthalmic high frequency ultrasound scanner (English PDF)

眼科高频超声诊断仪

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY 0849-2011 is the English-translated version of 眼科高频超声诊断仪.

YY 0849-2011 is the Chinese pharmaceutical industry standard for the ophthalmic high frequency ultrasound scanner, the instrument commonly called an ultrasound biomicroscope, which works between 30 MHz and 50 MHz.

It specifies the composition of the product and its basic parameters, the requirements, the test methods and the inspection rules, covering the working frequency, the axial and lateral resolution, the depth of penetration and the geometric accuracy of the image, the probe and its acoustic output, and the electrical safety of the device. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY 0849-2011

National Standard of the People's Republic of China

ICS: 11.040.50; 11.040.70
Classification: C 32;C41

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

Foreword
1 Scope
2 Normative references
3 Equipment components and basic parameters

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

This standard specifies the high-frequency ultrasound diagnostic ophthalmic composition of the product and basic parameters, requirements, test methods and inspection rules.

This standard applies to the frequency of 30MHz ~ 50MHz ophthalmic high frequency ultrasound diagnostic apparatus (hereinafter referred to as the device), the device is usually Called UBM UBM (ultrasoundbiomicroscope).

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 191-2008 Packaging - Pictorial signs

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.9-2008 Medical electrical equipment - Part 2-37. Ultrasound diagnostic and monitoring equipment requirements for the safety

GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard.

GB/T 14710-2009 Medical electrical equipment environmental requirements and test methods

YY 0773-2010 ophthalmic B-type ultrasonic diagnostic apparatus General technical conditions

3 Equipment components and basic parameters

3.1 Composition

The manufacturer shall publish the following information in a random file.

a) basic components, including all attachments and options;

b) each probe type, model, nominal frequency, focus and imaging mode.

3.2 Basic parameters

The manufacturer should publish the following information about the device in the product standard.

a) The nominal operating frequency ultrasound;

b) the nominal focal length;

c) gray scale;

d) scanning frame rate;

e) scanning range (width × depth);

f) Gain adjustment range (if any);

g) after image processing and signal processing mode (if any);

h) digital scan converter (DSC) capacity (if any);

i) the depth and adjust the display delay Step (if any).

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.9-2008

Similar standards

YY/T 1476-2016|YY/T 0773-2023|YY 9706.262-2021|YY 0592-2016|YY/T 1767-2021|GB/T 19890-2005

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