G/TBT/N/CHN/1612  
9 July 2021  
(21-5433) 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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Anesthesia 
machine, anesthesia system, anesthesia workstation; (HS: 9018); (ICS: 11.040.10)  
5. Title, number of pages and language(s) of the notified document:  National 
Standard of the P.R.C., Medical Electrical Equipment — Part 2-13: Particular Requirements 
For Basic Safety And Essential Performance Of An Anaesthetic Workstation (87 page(s), 
in Chinese)  
6. Description of content:  This standard is applicable to the basic safety and essential 
performance of an anaesthetic workstation for administering inhalational anaesthesia 
whilst continuously attended by a professional operator.  
This standard specifies particular requirements for  a complete anaesthetic workstation 
and the following anaesthetic workstation components which, although considered as 
individual devices in their own, may be utilized, in conjunction with other relevant 
anaesthetic workstation components, to form an anaes thetic workstation:  
• anaesthetic gas delivery system;  
• anaesthetic breathing system;  
• anaesthetic gas scavenging system;  
• anaesthetic vapour delivery system;  
• anaesthetic ventilator;  
• monitoring equipment;  
• alarm system;  
• protection device  
This standard is also applicable to those accessories intended by their manufacturer to be 
connected to an anaesthetic workstation where the characteristics of those accessories 
can affect the basic safety and essential performance of the anaesthetic workstatio n. G/TBT/N/CHN/1612  
 
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  This standard is not applicable to any anaesthetic workstation intended for use with 
flammable anaesthetic agents, as determined by annex BB.   
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:  To be determined  
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/crnattachme nts/2021/TBT/CHN/21_4576_00_x.pdf