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YY 0773-2010

Chinese Standard: 'YY 0773-2010'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0773-2010English279 Add to Cart Days<=3 General technical requirements for ophthalmic ultrasound B-mode scan Valid YY 0773-2010
YY 0773-2010Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

BASIC DATA
Standard ID YY 0773-2010 (YY0773-2010)
Description (Translated English) General technical requirements for ophthalmic ultrasound B-mode scan
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C41
Classification of International Standard 11.40.55; 11.040.50
Word Count Estimation 14,113
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard GB/T 191-2008; GB 9706.1; GB 9706.9; GB/T 14710; YY 0107-2005
Drafting Organization State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center
Administrative Organization National Standardization Technical Committee of Medical electrical equipment
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the ophthalmic composition of B-type ultrasonic diagnostic apparatus and basic parameters, requirements, test methods, marking and instructions for use. This standard applies to ultrasonic frequency range 10MHz ~ 25MHz ophthalmic B-type ultrasonic diagnostic apparatus (hereinafter referred to as diagnostic).

YY 0773-2010
General technical requirements for ophthalmic ultrasound B-mode scan
ICS 11.40.55; 11.040.50
C41
People's Republic of China pharmaceutical industry standards
Ophthalmic B-type ultrasonic diagnostic apparatus General technical conditions
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2)
Centralized.
This standard was drafted. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center, Tianjin Medical Technology has Madain
Limited.
The main drafters of this standard. busy Ashmore, Zhang Yusheng, Yan-group, Wang Zhijian, Jiang Shilin.
Ophthalmic B-type ultrasonic diagnostic apparatus General technical conditions
1 Scope
This standard specifies the composition and the basic parameters of ophthalmic B-type ultrasonic diagnostic apparatus, requirements, test methods, marking and instructions for use.
This standard applies to the ultrasonic frequency range 10MHz ~ 25MHz ophthalmic B-type ultrasonic diagnostic apparatus (hereinafter referred to as diagnostic).
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 Medical Electrical Equipment Part 1. General requirements for safety
GB 9706.9 Medical electrical equipment - Part 2-37. Ultrasound diagnostic and monitoring equipment requirements for the safety
GB/T 14710 medical electrical environmental requirements and test methods
A YY 0107-2005 ophthalmic ultrasound measuring instrument
3 Composition and basic parameters
3.1 Composition
The manufacturer shall publish the following information in the diagnostic product standard.
a) basic components, including all attachments and options;
b) for each probe type, nominal frequency, type, imaging mode.
3.2 Basic parameters
The manufacturer should publish the following information in the diagnostic product standard.
a) The nominal operating frequency ultrasound;
b) gray scale;
c) scanning frame rate;
d) B-type scanning range;
e) Gain adjustment range (if any);
f) after image processing and signal processing mode (if any);
g) a digital scan converter (DSC) capacity (if any).
4 Requirements
4.1 Working conditions
Shall satisfy the following operating conditions.
Related standard:   YY/T 0774-2019  YY 0774-2010
Related PDF sample:   YY 0766-2009  YY 0592-2016
   
 
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