G/TBT/N/KOR/466  
 
14 January 2014  
(14-0171)  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:  REPUBLIC OF KOREA  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Ministry of Food and Drug Safety 
Name and address (including telephon e 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 :  Documents 
are available from the Ministry Food and Drug safety website ( http://www.mfds.go.kr ). 
Also available from:  
International Cooperation Office 
Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro, Osong-eup, Cheongwon-gun, Chungcheongbuk-do, 363-
700  
Republic of Korea   Tel:  (+82) 43 719-1564 
Fax: (+82) 43-719-1550 
Email:  wtokfda@korea.kr  
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 langua ge(s) of the notified document:  Standards and 
Specifications for Electrical Mechanical Safety of Medical Devices (407 pages, available in 
Korean).     
6. Description of content:  Clarify and establish performance and safety requirements for 
medical electrical equipment and medical elec trical systems to enhance their safety, and 
harmonize domestic regulations with international standards. 
Applied International Standards: 
- IEC 60601-1-3:2008 Medical electrical equipment - Part 1-3: General 
 requirements for basic safety and esse ntial performance - Collateral standard: 
 Radiation protection in diagnostic X-ray equipment; 
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General 
 requirements for basic safety and esse ntial performance - Collateral standard: 
 Usability; 
- IEC 60601-1-8:2012 Medical electrical equipment - Part 1-8: General 
requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical 
equipment and medical electrical systems; 
- IEC 60601-1-10:2012 Medical electrical equipment - Part 1-10: General G/TBT/N/KOR/466 
 
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  requirements for basic safety and essential performance - Collateral Standard: 
Requirements for the development of physiologic closed-loop controllers. 
- IEC 61010-1:2001 Safety requirements for electrical equipment for measurement, 
control, and laboratory use Part 1: General requirements. 
- ISO 14708-1:2000 Implants for surgery - Active implantable medical devices - 
Part 1: General requirements for safety, marking and for information to be 
provided by the manufacturer.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of consumers and promotion of public health . 
8. Relevant documents:   The Ministry of Food and Drug Safety Advance Notice No. 2013-
301, 31 December 2013 (available in Korean)   
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 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 addresse s, if available of the other body:    
Technical Barriers to Trade(TBT) Division 
Korean Agency for Technology and Standards (KATS) 
96 Gyoyukwongil, Gwacheon-si, Gyeonggi-do, Rep. of  Korea 427-716 Tel.:  (+82) 2 509 7258/7259 Fax:  (+82) 2 507 1924 E-mail:  tbt@kats.go.kr    Website:  http://www.knowtbt.kr  
http://members.wto.org/crnattach ments/2014/tbt/KOR/14_0051_00_x.pdf