GB 4505-1984
Abolished
YY/T 0299-2022
Active
Industry standards-Medicine
YY/T 0299-2022 Medical ultrasonic couplants
YY/T 0299-2022 Medical ultrasonic couplants
Basic Information
Standard Code:
YY/T 0299-2022
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:
2022-07-01
Implement Date:
2024-07-01
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标准化分技术委员会(SAC/TC 10/SC 2)
Pages:
20 pages
Scope
本文件规定了医用超声耦合剂的术语和定义、产品分类、技术要求和试验方法。
本文件适用于医用超声耦合剂(以下简称产品)，也适用于医用超声耦合垫。
注： 关于医用超声耦合垫的说明，详见附录A。
Development Information
Drafting Units:
中国科学院声学研究所、湖北省医疗器械质量监督检验研究院、中国船舶重工集团公司第七一五研究所
Drafting Persons:
牛凤岐、梅享林、朱承纲、程洋、张迪、陈毅、柯虎、李玲
Replace the following standards
Referenced Standards
中华人民共和国药典(2020年版)四部
GB/T 15261-1994 Methods of measuring the acoustic characteristics of ultrasonically tissue-mimicking materials
GB/T 15261-2008 Measurement methods for acoustic properties of ultrasonically tissue-mimicking materials
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
Related Standards
GB 5579-1985
Abolished
GB 5579-1985 High-voltage cable plug and socket connections for medical X-ray equipment
GB 5665-1985
Abolished
GB 5665-1985 General specification for mechanical units of medical diagnostic X-ray equipment
GB 10151-1988
Abolished
GB 10151-1988 Medical X-ray equipment—Specification for high voltage cable plug and socket connections
GB/T 10149-1988
Active
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB 11239-1989
Replaced