G/TBT/N/CHN/1664  
5 April 2022  
(22-2722) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  CHINA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
State Administration for Market Regulation (Standardization Administration of the P.R.C.)  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notific ation shall be indicated if different from above:   
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  High flow 
oxygen inhaler, High flow respiratory therapeutic instrument, Transnasal high flow oxygen 
therapeutic instrument, Respiratory humidification therapeutic instrument  
5. Title, number of pages and language(s ) of the notified document:  National 
Standard of the P.R.C., Medical Electrical Equipment — Part 2 -90:Particular Requirements 
for Basic Safety and Essential Performance of Respiratory High Flow Therapy Equipment; 
(66 page(s), in Chinese)  
6. Description of  content:  This document specifies the basic safety and basic performance 
of high flow respiratory treatment equipment used in combination with accessories. Such 
medical devices are expected to be used for patients with spontaneous breathing; It is 
expected  to be used in patients who need to improve alveolar gas exchange and who can 
benefit from receiving high flow humidified respiratory gas, including those whose upper 
respiratory tract is bypassed.  
High flow respiratory therapy equipment can be: Fully inte grated ME equipment; Or an 
ME system formed by a discrete product portfolio.  
This document also applies to other types of respiratory devices with high flow respiratory 
treatment mode.  
The high flow respiratory therapy device is operable when moving.  The p rovisions of this 
document also apply to accessories intended by the manufacturer for connection to high 
flow respiratory therapy equipment, and the characteristics of such accessories may affect 
the basic safety and basic performance of high flow respirat ory therapy equipment.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements  
8. Relevant documents:   
- G/TBT/N/CHN/1664  
 
- 2 - 
 
  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  24 months after standard approval  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
WTO/TBT National Notification and Enquiry Center of the People's Republic of China  
Tel：+86 10 57954633/ 57954627  
E_mail: tbt@customs.gov.cn  
 
https://members.wto.org/crnattachments/2022/TBT/CHN/22_2576_00_x.pdf