G/TBT/N/PHL/177  
 
7 April 2014  
(14-2176)  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:  PHILIPPINES  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Center for Devices Regulation, Radiation Health and Research, 
Food and Drug Administrati on, Department of Health 
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 :   
Center for Devices Regulation, Radiation Health and Research 
Food and Drug Administration Department of Health San Lazaro Compound, Rizal Avenue 
Sta. Cruz, Manila 
Tel.: (632) 651-7800 loc. 3409 Fax:  711-6016 
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 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):  X-ray 
equipment for radiography and radioscopy. 
5. Title, number of pages and langua ge(s) of the notified document:  Draft Philippine 
National Standard (DPNS) / IEC 60601-2-54:2009  – Medical Electrical Equipment - Part 2-
54: Particular requirements for the basic safety and essential performance of X-ray 
equipment for radiography and radioscopy     
6. Description of content:  The Centre for Device Regulation, Radiation Health and 
Research (former Name: Bureau of Health Devices and Technology) of the Food and 
Drug Administration, Department of Health pr oposed to review an existing International 
Standard, the International Electrotechnica l Commission IEC 60601-2-54 – Particular 
requirements for the basic safety and essential performance of X-ray equipment for 
radiography and radioscopy.  The reviewed standard together with its amendments/modifications will be circulated for comments and if approved, will be 
adopted as Philippine National Standard.  This Philippine National Standard which is 
identical with the IEC standard will be used by the Centre for Device Regulation, Radiation Health and Research (former Name: Bureau of Health Devices and Technology) to regulate the use of radiology equipment in the Philippines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  For the protection of human health and safety G/TBT/N/PHL/177 
 
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  8. Relevant documents:   IEC 60601-1 - Medical Electrical Equipment - Part 1: General 
requirements for the basic safety and essential performance 
IEC 60601-1-3 - General requirements for the basic safety and essential performance – 
Collateral Standards:  Radiation protection in diagnostic x-ray equipment 
IEC 60601-2-54 – Medical Electrical Equipment - Part 2-54: Particular requirements for 
the basic safety and essential performance of X-ray equipment for radiography and 
radioscopy 
9. Proposed date of adoption:   
 
Proposed date of entry into force:    This order shall take effect 15 days after its 
publication in an official gazette of general 
circulation  This order shall take effect 15 days after its publication in an official gazette of general 
circulation      
10. Final date for comments:  22 May 2014 
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:    
Standards Develo pment Division 
Bureau of Product Standards Department of Tr ade and Industry 
361 Sen. Gil J. Puyat Avenue 
Makati City, Metro Manila Philippines E-mail:  bps@dti.gov.ph  
Fax:  (632) 751-4706