YY 0448-2003Ultrasonic Doppler foetal heart rate detectors (English PDF)
超声多普勒胎儿心率仪
This is a limited preview
Buy now to download the full PDF (22 pages)
Need quotation for your management?
Get a formal quotation for YY 0448-2003 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
February 9, 2003
Implementation date
September 1, 2003
Scope
YY 0448-2003 is the English-translated version of 超声多普勒胎儿心率仪.
YY 0448-2003 is the Chinese standard "Ultrasonic Doppler foetal heart rate detectors". Its scope clause reads: 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. Its clauses include terms and definitions.
Found what you need?
Document preview — YY 0448-2003
National Standard of the People's Republic of China
- Replacing
- YY 0013-1990
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 3.2 Acoustic operating frequency
- 3.3 Nominal working frequency
- 3.4 Comprehensive sensitivity
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
The ultrasonic working frequency is referred to by the manufacturing mark.
3.4 Comprehensive sensitivity
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 0593-2022 | YY 0307-2022 | YY 0592-2016 | YY/T 0449-2018 | YY/T 0458-2014 | […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY 0448
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0448-2003 | Ultrasonic Doppler foetal heart rate detectors | current edition | Current |
| YY 0013-1990 | Ultrasonic Doppler foetal heart rate detectors | previous edition | Superseded |
This page sells the current edition, YY 0448-2003. Earlier editions are listed for reference only.
How to Download YY 0448-2003
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY 0017-2026 — Implants for osteosynthesis - Metallic bone plates
YY 0018-2026 — Implants for osteosynthesis - Metallic bone screws
YY 0118-2026 — Joint replacement implants - Hip joint prostheses - Fundamental requirements
Secure payment via Stripe
Payments accepted
YY 0448-2003
$385.00