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YY 0042-2018 English PDF

YY 0042-2018 English PDF

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YY 0042-2018: High-frequency jet ventilator

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Scope

This Standard specifies the basic safety, performance, marking and information provided by the
manufacturer for high-frequency jet ventilator (hereinafter referred to as ventilator).
This Standard applies to high-frequency jet ventilator with both exhalation and inhalation open.
The device is suitable for use by patients who need respiratory support, respiratory therapy and
emergency resuscitation under the supervision of medical staff.

Basic Data

Standard ID YY 0042-2018 (YY0042-2018)
Description (Translated English) High-frequency jet ventilator
Sector / Industry Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 8,838
Date of Issue 2018-12-20
Date of Implementation 2020-06-01
Older Standard (superseded by this standard) YY 0042-2007
Quoted Standard GB/T 4999; GB 9706.1; GB 18278.1; GB 18279.1; GB 18280.1; GB 18281.1; GB 18281.2; GB 18281.3; GB 18281.4; GB 18281.5; YY/T 0466.1-2016; YY 0600.3-2007; YY 0601; YY 0709; YY/T 0799; YY/T 1040.1
Regulation (derived from) State Drug Administration Announcement No. 97 of 2018
Issuing agency(ies) State Drug Administration
Summary This standard specifies the basic safety, performance, marking and information provided by the manufacturer of high-frequency jet ventilators (hereinafter referred to as ventilators). This standard applies to high-frequency jet ventilators with both open breath and inhalation open. The device is intended for use by patients under the supervision of health care providers for respiratory support, respiratory therapy and first aid resuscitation.


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