YY/T 0448-2019 Active Industry standards-Medicine

YY/T 0448-2019 Ultrasonic Doppler fetal heartbeat detector

Publish Date: 2019-05-31 Implement Date: 2020-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0448-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical ultrasound, laser, and high-frequency instruments and equipment

ICS Name: X-ray imaging equipment

Publish Date: 2019-05-31

Implement Date: 2020-06-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用电器标准化技术委员会医用超声设备分技术委员会(SAC/TC 10/SC 2)

Pages: 7 pages

Scope

本标准规定了超声多普勒胎儿心率仪（也称“胎心音仪”“胎儿听诊器”）的术语和定义、要求和试验方法。
本标准适用于根据超声多普勒原理从孕妇腹部获取胎儿心脏运动信息的超声多普勒胎儿心率仪（以下简称“仪器”）。
本标准不适用于系附在孕妇腹部，采用多元扁平超声多普勒换能器的连续胎儿心率监护装置。

Development Information

Drafting Units:

湖北省医疗器械质量监督检验研究院

Drafting Persons:

王志俭、蒋时霖

Word Count: 12 Thousand words Pages: 7 pages

Replace the following standards

YY 0448-2009 Ultrasonic Doppler foetal heartbeat detector

Referenced Standards

YY/T 0749-2009 Ultrasonics—Hand-held probe Doppler foetal heartbeat detectors—Performance requirements and methods of measurement and reporting GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.9-1997 Medical electrical equipment—Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment GB 9706.9-2008 Medical electrical equipment—Part 2-37:Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment

Related Standards

GB 4505-1984 Abolished

GB 4505-1984 The general specifications on medical diagnostic X-ray generating unit

Publish Date: 1984-06-22

GB 5579-1985 Abolished

GB 5579-1985 High-voltage cable plug and socket connections for medical X-ray equipment

Publish Date: 1985-10-31

GB 5665-1985 Abolished

GB 5665-1985 General specification for mechanical units of medical diagnostic X-ray equipment

Publish Date: 1985-11-30

GB 10151-1988 Abolished

GB 10151-1988 Medical X-ray equipment—Specification for high voltage cable plug and socket connections

Publish Date: 1988-12-22

GB/T 10149-1988 Active

GB/T 10149-1988 Terminology and symbol for medical X-ray equipment

Publish Date: 1988-12-22

GB 11239-1989 Replaced

GB 11239-1989 The operation microscope

Publish Date: 1989-03-31