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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 0449-2018 English PDF

US$179.00 · In stock
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YY/T 0449-2018: Ultrasonic Doppler fetal monitor
Status: Valid

YY/T 0449: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0449-2018	English	179	Add to Cart	3 days [Need to translate]	Ultrasonic Doppler fetal monitor	Valid	YY/T 0449-2018
YY 0449-2009	English	359	Add to Cart	3 days [Need to translate]	Ultrasonic Doppler fetal monitor	Obsolete	YY 0449-2009
YY 0449-2003	English	719	Add to Cart	5 days [Need to translate]	Ultrasonic Doppler foetal monitor	Obsolete	YY 0449-2003

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Basic data

Standard ID	YY/T 0449-2018 (YY/T0449-2018)
Description (Translated English)	Ultrasonic Doppler fetal monitor
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C41
Classification of International Standard	11.040.50
Word Count Estimation	9,937
Date of Issue	2018-11-07
Date of Implementation	2019-11-01
Older Standard (superseded by this standard)	YY 0449-2009
Quoted Standard	GB 9706.1; GB 9706.9; GB/T 14710; YY 0709; YY/T 1142
Regulation (derived from)	Announcement No. 87 of 2018 by the State Drug Administration
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the terms and definitions, requirements, test methods and inspection rules for ultrasound Doppler fetal monitors. This standard applies to the ultrasound Doppler fetal monitor (hereinafter referred to as "instrument"), the product uses continuous wave or pulse wave ultrasound Doppler principle, continuous monitoring of the fetus during the perinatal period, and timely provided in case of abnormality Alarm information.

YY/T 0449-2018: Ultrasonic Doppler fetal monitor

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ultrasonic Doppler fetal monitor ICS 11.040.50 C41 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0449-2009 Ultrasound Doppler fetal monitor Published on.2018-11-07 2019-11-01 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 0449-2009 "Ultrasonic Doppler fetal monitor", compared with YY 0449-2009, except for editorial changes The main technical changes are as follows. --- Modified the definition of ultrasound Doppler fetal monitor (see 3.1, 3.1 of the.2009 edition); --- Removed the content of the product category (see Chapter 4 of the.2009 edition); --- Increased the temperature drift indicator of the contraction pressure value (see 4.6); --- Modified the requirements for the storage record function (see 4.7, see 5.6 of the.2009 version). The documents of our country that have a consistent correspondence with the international documents referenced by the standard norms are as follows. GB-9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1.1988, IDT); --- GB 9706.9-2008 Medical electrical equipment - Part 2-37. Particular requirements for safety of ultrasonic diagnostic and monitoring equipment (IEC 60601-2-37.2001, IDT); --- YY 0709-2009 Medical electrical equipment - Part 1-8. General requirements for safety - Parallel standard. General requirements, medical Testing and guidance for alarm systems in gas and medical electrical systems (IEC 60601-1-8.2003, IDT). Some elements of this standard may involve patents. The issuing organization of this standard does not assume responsibility 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 0164-1994; ---YY 0449-2003; ---YY 0449-2009. Ultrasound Doppler fetal monitor

1 Scope

This standard specifies the terms and definitions, requirements, test methods and inspection rules for ultrasound Doppler fetal monitors. This standard applies to ultrasound Doppler fetal monitor (hereinafter referred to as "instrument"), which uses continuous wave or pulse wave ultrasound Doppler Principle, continuous monitoring of the fetus during the perinatal period, and timely provide alarm information when an abnormality occurs.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies 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 medical ultrasound diagnostic and monitoring equipment GB/T 14710 Medical electrical requirements and test methods YY 0709 Medical electrical equipment - Part 1-8. Safety general requirements. Parallel standard. General requirements, medical electrical equipment and medical Testing and guidance for alarm systems in electrical systems YY/T 1142 Medical Ultrasound Equipment and Probe Frequency Characteristics Test Method

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 A device that continuously monitors the fetus during the perinatal period and provides alarm information in the event of an abnormality. The host, the ultrasound probe, and the palace Compressed pressure sensor and other sensors connected to it, using ultrasonic Doppler principle to detect fetal heart rate, with monitoring and storage Fetal heart rate, contraction pressure, and other parameters.

4 requirements

4.1 Ultrasonic operating frequency The deviation of the ultrasonic operating frequency fW from the nominal frequency should be no more than ±10%. 4.2 fetal heart rate measurement and display range The measurement and display range of fetal heart rate should be no narrower than 65 times/min~210 times/min. 4.3 fetal heart rate measurement error The error in fetal heart rate measurement should be no more than ± 2 times/min. 4.4 Alarm function The fetal heart rate alarm should meet the requirements specified in YY 0709, and the alarm state delay should not exceed 30s.

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