G/TBT/N/BDI/65  
15 January 2020  
(20-0408) 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 suture 
needles — Specification (14 page(s), in English)  
6. Description of content:  This Draft East African Standard specifies the requirements, 
sampling and test methods for surgical suture needles.  
7. Objective and rationale, including the nat ure of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements; Harmonization  
8. Relevant documents:   
• ASTM A751 -01, Standard Test Methods, Practices, and Terminology for 
Chemical Analysis of Steel Products  
• ASTM F1089 -02, Standard Test Method for Corrosion of Surgical Instruments  
• ASTM F1840 -10, Standard Terminology for Surgical Suture Needles  
• ISO 6507 -1, Metallic mate rials —Vicker hardness test — Part 1: Test method  
• ISO 24153 , Random sampling and randomisation procedures  
• ISO 13402, Surgical and dental hand instruments — Determination of resistance 
against autoclaving, corrosion and thermal exposure  
• ASTM F3014 – 14, Standard Test Method for Penetration Testing of Needles 
Used in Surgical Sutures  G/TBT/N/BDI/65  
 
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  • ASTM F1874 - 98, Standard Test Method for Bend Testing of Needles Used in 
Surgical Sutures  
• IS 1501:2002 , Method for Vickers hardness test for metallic materials (Third 
Revisi on).  
• IS 7531 (1990): Surgical Instruments — Corrosion Resistance of Stainless Steel 
Surgical Instruments — Methods of Tests.  
• IS 9165 (Part 1): 1992, Surgical instruments — Needles, suture Part 1 — 
Specification .  
• ISO 6507 -2:2018, Metallic materials — Vickers hardness test — Part 2: 
Verification and calibration of testing machines  
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