G/TBT/N/EGY/220  
17 September 2019  
(19-5930) 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:  EGYPT   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Egyptian Organization for Standardization and Quality  
16 Tadreeb El -Modarrebeen St., Ameriya, Cairo - Egypt  
E-mail: eos@idsc.net.eg /tbteos@eos.org.eg  
Website: http://www.eos.org.eg  
Tel.: + (202) 22845528  
Fax: + (202) 22845504  
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 indicat ed 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):  Quality 
management and quality assurance (ICS 03.120.10), Laboratory medicine in general 
(ICS 11.100.01)  
5. Title, number of pages and language(s) of the notified document:  Draft Egyptian 
standard for "Medical analysis laboratories – minimum requirements for design, 
administrative and technical requirements for construction and operation". (19 page(s), 
in Arabic)  
6. Description of content:  This draft standard includes the m inimum design, 
administrative and technical requirements for the establishment and operation of medical 
analysis laboratories.  
This standard also refers to the procedures that must be taken in order to reduce the 
spread of serious and infectious diseases w ithin the working environment of medical 
laboratories.  
Worth mentioning is that this draft standard complies with:  
• ISO 15189:2012.  
• Laboratory quality management system: handbook - 1. Laboratories — 
organization and administration, 2. Laboratories — handboo ks, 3. Laboratories 
techniques and procedures — standards, 4.Quality control, 5.Manual - WHO 
document No. (ISBN 978 92 4 154827 4) Version 1.1.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Safety and health requirements  G/TBT/N/EGY/220  
 
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  8. Relevant documents:   
• ISO 15189:2012.  
• WHO document No. (ISBN 978 92 4 154827 4) Version 1.1.  
• Laboratory quality management system: handbook.1.Laboratories — 
organization and administration, 2. Laboratories — handbooks, 3. Laboratories 
techniques and procedures — standards, 4.Quality control, 5.Manual.  
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 [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Egyptian Organization for Standardization and Quality  
Address: 16 Tadreeb El -Modarrebeen St.  
Ameriya, Cairo - Egypt  
E-mail: eos@idsc.net.eg /eos.tbt@eos.org.eg  
Website: http://www.eos.org.eg  
Tel.: + (202)  22845528  
Fax: + (202) 22845504