G/TBT/N/CHN/1677  
18 May 2022  
(22-3843) 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):  Near 
infrared functional brain imaging device, near infrared spectral functional brain imaging 
system, quantitative brain function imaging dev ice (HS code(s): 901820; 902750; 
903149); (ICS code(s): 11.040.55)  
5. Title, number of pages and language(s) of the notified document:  National 
Standard of the P.R.C., Medical electrical equipment –Part 2 -71: Particular requirements 
for the basic safety a nd essential performance of functional near -infrared spectroscopy 
(NIRS) equipment; (32 page(s), in Chinese)  
6. Description of content:  This document applies to the basic safety and essential 
performance of functional NIRS equipment intended to be used by  themselves, or as a 
part of an ME system, for adjunctive diagnostic purposes.  
Not included within the scope of this particular standard are:  
a) the equipment, as a part of ME equipment, measures oxygen saturation of the 
haemoglobin in the micro vessels (c apillaries, arterioles and venules);  
b) near -infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended 
for obtaining functional NIRS equipment output;  
c) pulse oximeter equipment, which is not intended for obtaining functional NIRS 
equipment output. The requirements for pulse oximeter equipment are found in YY 
9706.261.  
d) frequency -domain and time -domain equipment for functional near -infrared 
spectrosco py may be subject to different test procedures than those defined herein.  
e) functional near -infrared spectroscopy equipment, which measure changes in the 
concentration of chromophores other than oxy - and deoxy -haemoglobin may be subject 
to different test procedures than those defined herein.  G/TBT/N/CHN/1677  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
- 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  24 months after 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_3481_00_x.pdf