. /. WORLD TRADE  
ORGANIZATION   
G/TBT/N/CHN/52 
6 May 2004  
 
(04-2026) 
Committee on Technical Barriers to Trade Original:  English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   THE PEOPLE’S REPUBLIC OF CHINA 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Standardization Administration of China (SAC) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification 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 app licable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Water Heating-Cooling 
System for Artificial Heart-Lung Machine (UDC616.1-77)(C45). 
ICS 11.040.60 
5. Title, number of pages and language(s) of the notified document:   Water Heating-
Cooling System for Artificial Heart-Lu ng Machine (5 pages, in Chinese). 
6. Description of content:   Water heating-cooling system fo r artificial heart-lung machine is 
the drive for heated water, cooled water a nd raw water in heat exchanger of the extra 
corporeal blood heat exchanging system.  It is  the temperature adjuster for medical facilities 
in extra corporeal perfusion. 
 
 The standard is the revised edition of  GB12263-90 Water Heating-Cooling System 
for Artificial Heart-Lung Machine.  The main differences between this standard and the 
original one are:   1. It followed GB9706.1-1995 “Medical Electr ical Equipment pa rt 1: General 
Requirements for Safety”. 
2. It followed GB/T 14710-1993 “The Environm ental Requirements and Test Methods 
for Medical Electrical Equipment”. 
3. It adds the type of automatic temperatur e changing and circulation, and sets the 
requirement for heating and cooling speed. 
4. Requirements for flow rate and volume of the heating-cooling system are improved. 
5. Requirements for outlet and inlet connector of the heating-cooling system are 
added. 
6. Requirements for marks of inlet, outlet, water line or instructions are added. 
 
 If the faults (e.g. mains fuse, over-current  release, electrolyte strength, continuous 
leakage, protective earth resistance) of electri cal safety of water heating-cooling system 
occur, the operators might get an electric shoc k.  Water heating-cooling system is usually G/TBT/N/CHN/52 
Page 2  
 
used in an operating room, and the moisture or the mixture of air, O
2, NO 2, and anaesthetic, 
detergent would easily cause fire or explosion.  If the faults of important performance of the 
water heating-cooling system occur, the bl ood temperature of the patient being operated 
would be out of control and threatens the person’ s life.  Therefore all the technical contents 
in the standard are compulsory.  From the day it is published, the original standard will be 
replaced and abolished. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
For the protection of human safety and health 
8. Relevant documents:   - 
9. Proposed date of adoption:   
Proposed date of entry into force:   To be determined 
10. Final date for comments:   60 days from the date of notification 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:        
China WTO/TBT National Enquiry Point 
Tel.:  +86 10 82260618 
Fax:  +86 10 82262448 E-mail:  tbt@aqsiq.gov.cn