G/TBT/N/TZA/377  
15 January 2020  
(20-0400) 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:  TANZANIA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Tanzania Bureau of Standards  
MOROGORO/Sam Nujoma Road, Ubungo  
P O BOX 9524  
Tel: +255 222450206  
Email: nep@tbs.go.tz  
Website: www.tbs.go.tz  
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 [   ], 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:  DEAS 1019 -1: 
2019 Surgical sutures — Specification — Part 1: Absorbable (14 page(s), in English)  
6. Description of content:  This Draft East African Standard specifies the requirements, 
sampling and test methods for absorbable surgical s utures  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Quality requirements  
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 of health care products -- Radiation -- Part 1: 
Requirements for development, va lidation and routine control of a sterilization process 
for medical devices  
ISO 11137 -2:2013, Sterilization of health care products -- Radiation -- Part 2: 
Establishing the sterilization dose  
SO 11137 -3:2017, Sterilization of health care products -- Radiat ion -- 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 sterilizatio n 
process for medical devices ISO/TS 17665 -2:2009, Sterilization of health care products G/TBT/N/TZA/377  
 
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  -- 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: 
Biologic al 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:  April 2020  
Proposed date of entry into force:  Upon declaration as a mandator y by the Minister 
for Industry, Trade and Investment  
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:   
Tanzania Bureau of Standards  
MOROGORO/Sam Nujoma Road, Ubungo  
P O BOX 9524  
Tel: +255 222450206  
Email: nep@tbs.go.tz  
Website: www.tbs.go.tz  
https://members.wto.org/crnattachments/2020/TBT/TZA/20_0405_00_e.pdf