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YY/T 1685-2020

Chinese Standard: 'YY/T 1685-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1685-2020English159 Add to Cart Days<=3 Pneumatic impulse oscillation equipment for sputum excretion Valid YY/T 1685-2020
YY/T 1685-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YYT1685-2020 (YYT1685-2020)
Description (Translated English) Pneumatic impulse oscillation equipment for sputum excretion
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 8,839
Date of Issue 2020-02-21
Date of Implementation 2021-01-01
Drafting Organization Tianjin Medical Device Quality Supervision and Inspection Center, Wuxi Warner Medical Technology Co., Ltd., Suzhou Haobo Medical Device Co., Ltd., Beijing Medical Device Technology Evaluation Center
Administrative Organization National Medical Appliance Standardization Technical Committee Physical Therapy Equipment Sub-Technical Committee (SAC / TC 10 / SC 4)
Regulation (derived from) Announcement No. 20 of 2020 by the State Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the Sub-Technical Committee for Physical Therapy Equipment (SAC/TC10/SC4) of the National Medical Appliance Standardization Technical Committee.
This standard was mainly drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Wuxi Warner Medical Technology Co., Ltd., Suzhou Haobo
Medical Device Co., Ltd., Beijing Medical Device Technology Evaluation Center.
The main drafters of this standard. Qi Lijing, Zhou Huilin, Qian Xuebo, Yang Guojuan, Chen Ran, Fan Weihua, Zhang Jianwu.
Pneumatic pulse oscillation sputum discharge device
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements, test methods of pneumatic pulse oscillation sputum discharge equipment (hereinafter referred to as equipment).
This standard applies to the pulsed airflow generated by the air pulsed airflow generator.
Device for discharging respiratory secretions. For a multi-function device (if there is an atomization function), the content specified in this standard is only applicable to the device
The sputum discharge function of Pneumatic Pulse Oscillation Principle is prepared.If other functions have corresponding national standards and/or industry standards, they should also comply with other relevant
Standard requirements.
This standard does not apply to vibration tapping sputum discharge machine.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB 9706.1 Medical Electrical Equipment Part 1. General Requirements for Safety
GB/T 14710 Environmental requirements and test methods for medical appliances
GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management
YY 0505 Medical electrical equipment Part 1-2. General requirements for safety Parallel standards. Electromagnetic compatibility requirements and tests
Related standard:   YY/T 1624-2019  YY/T 1626-2019
Related PDF sample:   YY/T 1095-2015  YY 0950-2015
   
 
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