G/TBT/N/BDI/66  
15 January 2020 
(20-0409) 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:  BURUNDI   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Burundi Bureau of Standards and Quality Control (BBN)  
Boulevard de la Tanzanie N° 500  
BP: 3535 Bujumbura, Burundi  
Tel: +25722221815/+25722221577  
E- Mail: info@bbnburundi.org  
Website: www.b bn-burundi.org  
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 [X], 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):  Surgical 
instruments and materials (ICS 11.040.30)  
5. Title, number of pages and language(s) of the notified document:  Surgical sutures 
— Specification — Part 1: Absorbable (20 page(s), in English)  
6. Description of content:   This Draft East African Standard specifies the requirements, 
sampling and test methods for absorbable surgical sutures.  
7. Objective and rationale , including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements; Harmonization  
8. Relevant documents:   
• ISO 10993 (all parts), Biological evaluation of medical devices  
• ISO 24153 — Random sampling and randomisation procedures  
• British Pharmacopoeia , 2017  
• ISO 11135:2014, Sterilization of health care products — Ethylene oxide  
• ISO 11137 -1:2006, Sterilization o f health care products -- Radiation -- Part 1: 
Requirements for development, validation and routine control of a sterilization 
process for medical devices  
• ISO 11137 -2:2013, Sterilization of health care products -- Radiation -- Part 2: 
Establishing the ste rilization dose  G/TBT/N/BDI/66  
 
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  • ISO 11137 -3:2017, Sterilization of health care products -- Radiation -- Part 3: 
Guidance on dosimetric aspects of development, validation and routine control  
• ISO 17665 -1:2006, Sterilization of health care products -- Moist heat -- Part 1:  
Requirements for the development, validation and routine control of a 
sterilization process for medical devices  
• ISO/TS 17665 -2:2009, Sterilization of health care products -- Moist heat -- Part 
2: Guidance on the application of ISO 17665 -1  
• ISO 11138 -3:2017, Sterilization of health care products -- Biological indicators -
- Part 3: Biological indicators for moist heat sterilization processes  
• US Pharmacopoeia 40, 2019  
• US 1958 -1:2019, Surgical sutures — Specification — Part 1: Absorbable  
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 [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Documentation and Information Centre Division at BBN  
Boulevard de la Tanzanie N° 500  
BP: 3535 Bujumbura, Burundi  
Tel: +25722221815 or +25722221577  
E- Mail: info@bbnburundi.org  
Website: www.bbn -burundi.org