. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/KOR/370 
5 June 2012  
 (12-2941) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  REPUBLIC OF KOREA  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Korea Food and Drug Administration 
Name and address (including telephone and fax numbers, email and website 
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 applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medical devices 
5. Title, number of pages and language(s) of the notified document:  Proposed revision of 
Standards and Specifications fo r Medical Devices (p.8-p.199, available in Korean)     
6. Description of content:  With a view to harmonize domestic regulations with international 
norms, the individual standards and specificatio ns for "Heater system", "Radiation shield 
partition" are revised.  
<Applied international norms:> 
- Heater syst em: KS C IEC 60601-2-35:2002; 
- Radiation shield partition: IEC 61331-2:1994. 
The proposed measure establishes the individu al standards and specifications for blood-
glucose monitoring system that makes measurement accuracy into +/- 15% with a view to 
harmonizing domestic regulations with internatio nal norms (draft international standards of 
ISO 15197). 
The proposed measure establishes the 7 individu al standards and specifications including 
"blood-glucose monitoring system"  
The established 7 individual standa rd standards and specifications 
 Individual standards and specific ations Applied international norms 
1 Thermometer, elec tronic, infrared, ear ASTM E 1965:2009 
2 Inhalators for medical use ISO 27427:2010 G/TBT/N/KOR/370 
Page 2  
 
  3 Electromyograph and evok ed response IEC 60601-2-40:1998 
4 large moist heat Sterilizer BS EN 285:2006+A2:2009 
5 Heater, infant IEC 60601-2-21:1996 6 Pediatric phototherapy unit IEC 60601-2-50:2000 7 Self-testing Glucose meter and Blood 
glucose test strip ISO/DIS 15197 
The proposed measure unifies th e standards and specifications  for diagnostic X-ray system. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of consumers and promotion of public health  
8. Relevant documents:   The Korea Food and Drug Admi nistration Advance Notice No. 2012-
102, 15 May 2012 (available in Korean)   
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 
10. Final date for comments:  60 days from date of notification 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
Documents are available from the Korea Food and Drug Administration website 
(www.kfda.go.kr). Also available from:  
International Trade & Statistics Office 
Korea Food and Drug Administration #187 Osongsaengmyeong2(i)-ro, Os ong-eup, Cheongwon-gun  
Chungcheongbuk-do, 363-700 
Republic of Korea   Tel.:  (+82) 43 719 1565 Fax:  (+82) 43 719 1550 Email:  wtokfda@korea.kr  
http://members.wto.org/crna ttachments/2012/tbt/KOR/12_2031_00_x.pdf