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YY/T 0448: Historical versions
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| YY/T 0448-2019 | English | 199 |
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3 days [Need to translate]
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Ultrasonic Doppler fetal heartbeat detector
|
| YY 0448-2009 | English | 319 |
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3 days [Need to translate]
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Ultrasonic Doppler foetal heartbeat detector
|
| YY 0448-2003 | English | RFQ |
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6 days [Need to translate]
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Ultrasonic Doppler foetal heartbeat detector
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Basic data
| Standard ID | YY/T 0448-2019 (YY/T0448-2019) |
| Description (Translated English) | Ultrasonic Doppler fetal heartbeat detector |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C41 |
| Classification of International Standard | 11.040.50 |
| Word Count Estimation | 10,169 |
| Date of Issue | 2019 |
| Date of Implementation | 2020-06-01 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the terms and definitions, requirements and test methods of ultrasound Doppler fetal heart rate instrument (also known as "fetal heart sound instrument" and "fetal stethoscope"). This standard applies to the ultrasound Doppler fetal heart rate instrument (hereinafter referred to as "the instrument") that obtains fetal heart motion information from the abdomen of the pregnant woman according to the principle of ultrasound Doppler. This standard does not apply to continuous fetal heart rate monitoring devices that are attached to the abdomen of pregnant women and use multiple flat ultrasound Doppler transducers. |
YY/T 0448-2019: Ultrasonic Doppler fetal heartbeat detector
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Ultrasonic Doppler fetal heartbeat detector
ICS 11.040.50
C41
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0448-2009
Ultrasound Doppler fetal heart rate monitor
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0448-2009 "ultrasound Doppler fetal heart rate meter".
The main changes in this standard compared with YY 0448-2009 are as follows.
--- Removed two reference standards "GB/T 16846-2008" and "YY/T 1142-2003" (see Chapter 2 of the.2009 edition);
--- Added the definition of "ultrasonic Doppler fetal heart rate monitor" (see 3.1);
--- Removed duplicate definitions from YY/T 0749-2009 (see 3.2, 3.3, 3.5 and 3.8 of the.2009 edition);
--- Added "fetal heart rate measurement and display range" and "fetal heart rate measurement error" (see 4.3 and 4.4);
--- Removed "space peak time peak sound pressure" "output ultrasonic power" and "effective area of ultrasonic transducer sensitive components" (see
4.3, 4.4 and 4.5) of the.2009 edition;
--- Removed "power supply voltage adaptability" and "continuous working time" (see 4.7 and 4.8 in.2009);
---Modified the test method of "sound operating frequency" (see 5.1, 5.1 of.2009 edition);
--- Added test methods for "fetal heart rate measurement and display range" and "fetal heart rate measurement error" (see 5.3 and 5.4);
--- Removed the "output power" "space peak time peak sound pressure" and "effective area of ultrasonic transducer sensitive components" test method
(See 5.2, 5.3 and 5.4 of the.2009 edition);
--- Removed the test method of "power supply voltage adaptability" and "continuous working time" (see 5.7 and 5.8 of.2009 edition);
--- Removed the "inspection rules" (see Chapter 6 of the.2009 edition).
It is noted that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Medical Ultrasound Equipment Subcommittee (SAC/TC10/SC2).
This standard was drafted. Hubei Medical Device Quality Supervision and Inspection Institute.
The main drafters of this standard. Wang Zhiwei, Jiang Shilin.
The previous versions of the standards replaced by this standard are.
---YY 0013-1990;
---YY 0448-2003;
---YY 0448-2009.
Ultrasound Doppler fetal heart rate monitor
1 Scope
This standard specifies the terms and definitions, requirements and tests of ultrasound Doppler fetal heart rate monitor (also known as "fetal heart sound instrument" "fetal stethoscope").
method.
This standard is applicable to ultrasound Doppler fetal heart rate monitor for obtaining fetal heart motion information from pregnant women's abdomen according to the principle of ultrasound Doppler.
(hereinafter referred to as "instrument").
This standard does not apply to continuous fetal heart rate monitoring devices that are attached to the abdomen of pregnant women using a multi-flat ultrasound Doppler transducer.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.9 Medical electrical equipment - Part 2-37. Particular requirements for safety of ultrasonic diagnostic and monitoring equipment
GB/T 14710 Medical electrical requirements and test methods
YY/T 0749-2009 Ultrasound hand-held probe Doppler fetal heart rate tester performance requirements and measurement and reporting methods
3 Terms and definitions
The following terms and definitions as defined in YY/T 0749-2009 apply to this document.
3.1
An instrument that provides fetal heart rate information in a digital display and/or sound output in accordance with the ultrasound Doppler principle.
3.2
Acoustic operating frequency
Based on observing the frequency of the acoustic signal output by the hydrophone placed in the sound field.
3.3
Nominal working frequency nominalacousticworkingfrequency
The ultrasonic working frequency is referred to by the manufacturing mark.
3.4
Comprehensive sensitivity overalsensitivity
Above the noise level, the instrument detects Dopp from a simulated point target (width less than 3 wavelengths) that is lost by known plane wave reflections.
A measure of the signal capability of the target at a specified distance from the probe and moving at a specified speed. The overall sensitivity is determined by equation (1).
S=ABC (1)
In the formula.
S---comprehensive sensitivity in decibels (dB);
YY/T 0448-2019
Ultrasonic Doppler fetal heartbeat detector
ICS 11.040.50
C41
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0448-2009
Ultrasound Doppler fetal heart rate monitor
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0448-2009 "ultrasound Doppler fetal heart rate meter".
The main changes in this standard compared with YY 0448-2009 are as follows.
--- Removed two reference standards "GB/T 16846-2008" and "YY/T 1142-2003" (see Chapter 2 of the.2009 edition);
--- Added the definition of "ultrasonic Doppler fetal heart rate monitor" (see 3.1);
--- Removed duplicate definitions from YY/T 0749-2009 (see 3.2, 3.3, 3.5 and 3.8 of the.2009 edition);
--- Added "fetal heart rate measurement and display range" and "fetal heart rate measurement error" (see 4.3 and 4.4);
--- Removed "space peak time peak sound pressure" "output ultrasonic power" and "effective area of ultrasonic transducer sensitive components" (see
4.3, 4.4 and 4.5) of the.2009 edition;
--- Removed "power supply voltage adaptability" and "continuous working time" (see 4.7 and 4.8 in.2009);
---Modified the test method of "sound operating frequency" (see 5.1, 5.1 of.2009 edition);
--- Added test methods for "fetal heart rate measurement and display range" and "fetal heart rate measurement error" (see 5.3 and 5.4);
--- Removed the "output power" "space peak time peak sound pressure" and "effective area of ultrasonic transducer sensitive components" test method
(See 5.2, 5.3 and 5.4 of the.2009 edition);
--- Removed the test method of "power supply voltage adaptability" and "continuous working time" (see 5.7 and 5.8 of.2009 edition);
--- Removed the "inspection rules" (see Chapter 6 of the.2009 edition).
It is noted that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Medical Ultrasound Equipment Subcommittee (SAC/TC10/SC2).
This standard was drafted. Hubei Medical Device Quality Supervision and Inspection Institute.
The main drafters of this standard. Wang Zhiwei, Jiang Shilin.
The previous versions of the standards replaced by this standard are.
---YY 0013-1990;
---YY 0448-2003;
---YY 0448-2009.
Ultrasound Doppler fetal heart rate monitor
1 Scope
This standard specifies the terms and definitions, requirements and tests of ultrasound Doppler fetal heart rate monitor (also known as "fetal heart sound instrument" "fetal stethoscope").
method.
This standard is applicable to ultrasound Doppler fetal heart rate monitor for obtaining fetal heart motion information from pregnant women's abdomen according to the principle of ultrasound Doppler.
(hereinafter referred to as "instrument").
This standard does not apply to continuous fetal heart rate monitoring devices that are attached to the abdomen of pregnant women using a multi-flat ultrasound Doppler transducer.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.9 Medical electrical equipment - Part 2-37. Particular requirements for safety of ultrasonic diagnostic and monitoring equipment
GB/T 14710 Medical electrical requirements and test methods
YY/T 0749-2009 Ultrasound hand-held probe Doppler fetal heart rate tester performance requirements and measurement and reporting methods
3 Terms and definitions
The following terms and definitions as defined in YY/T 0749-2009 apply to this document.
3.1
An instrument that provides fetal heart rate information in a digital display and/or sound output in accordance with the ultrasound Doppler principle.
3.2
Acoustic operating frequency
Based on observing the frequency of the acoustic signal output by the hydrophone placed in the sound field.
3.3
Nominal working frequency nominalacousticworkingfrequency
The ultrasonic working frequency is referred to by the manufacturing mark.
3.4
Comprehensive sensitivity overalsensitivity
Above the noise level, the instrument detects Dopp from a simulated point target (width less than 3 wavelengths) that is lost by known plane wave reflections.
A measure of the signal capability of the target at a specified distance from the probe and moving at a specified speed. The overall sensitivity is determined by equation (1).
S=ABC (1)
In the formula.
S---comprehensive sensitivity in decibels (dB);
...
