GB/T 14199-1993
Replaced
YY/T 1035-2021
Active
Industry standards-Medicine
YY/T 1035-2021 Stethoscope
YY/T 1035-2021 Stethoscope
Basic Information
Standard Code:
YY/T 1035-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Normal diagnostic instruments
ICS Name:
Electroacoustics
Publish Date:
2021-03-09
Implement Date:
2022-04-01
Publisher:
国家药品监督管理局
Technical Committee:
医用电声设备医疗器械标准化技术归口单位
Pages:
11 pages
Scope
本标准规定了听诊器的术语和定义、要求、试验方法。
本标准适用于听诊器，包括电子听诊器。
Development Information
Drafting Units:
江苏省医疗器械检验所、上海市医疗器械检测所、江苏鱼跃医疗设备股份有限公司、江苏鹿得医疗电子股份有限公司、广东汉泓医疗科技有限公司
Drafting Persons:
胡济民、张宜川、刘茹、王大伟、张海敏、邓国鑫、祝增凯、姜列龙、黄真江、王皓、黄毅新、杨红光
Replace the following standards
YY/T 91077-1999
YY 91035-1999 Stethoscope
Referenced Standards
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
YY/T 0076-1992
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
Related Standards
GB/T 4128-1995
Active
GB/T 4128-1995 Acoustics—Standard hydrophone
GB/T 15953-1995
Replaced
GB/T 15953-1995 Instruments for the measurement of aural acoustic impedance/admittance
GB/T 16540-1996
Active
GB/T 16540-1996 Acoustics—Measurement and characterisation of ultrasonic fields in the frequency range 0.5MHz to 15MHz—Hydrophone method
YY/T 0458-2003
Replaced
YY/T 0458-2003 Technical requirements for ultrasonically blood-mimicking Doppler phantom
GB/T 20441.4-2006
Active