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1.
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Notifying
Member: NIGERIA
If applicable, name of local government involved (Articles 3.2 and 7.2):
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2.
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Agency
responsible:
Standards
Organisation of Nigeria (SON)
52, Lome
Crescent, Wuse Zone 7,
Federal
Capital Territory, Abuja, Nigeria
Telephone:
+2348033162789
Website: http://www.son.gov.ng
E-mail:
wto.tbt.nep@son.gov.ng, chivivlinjet@yahoo.com
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3.
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Notified
under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:
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4.
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Products covered (HS codes or national tariff lines. ICS numbers may
be provided in addition, where applicable): Sterile surgical
catgut, similar sterile suture materials and sterile tissue adhesives for
surgical wound closure; sterile laminaria and sterile laminaria tents;
sterile absorbable surgical or dental haemostatics (HS code(s): 300610)
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5.
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Details of notified document(s) (title,
number of pages and languages, means of access): DARS 2153-2:2025,
Surgical sutures -Part 2 Non -absorbable first edition; (23 page(s), in
English)
Link to notified document(s) and/or contact
details for agency or authority which can provide copies upon request:
Mrs. Chioma Chudi-Anaukwu
Standards Organisation of Nigeria (SON)
52, Lome Crescent, Wuse Zone 7,
Federal Capital Territory, Abuja, Nigeria
www.son.gov.ng
Telephone: +2348033162789
Email: wto.tbt.nep@son.gov.ng, chivivlinjet@yahoo.com
Website: www.son.gov.ng
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6.
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Description
of content: 1.1 This Draft African
Standard specifies the requirements, sampling and test methods for
non-absorbable surgical sutures and surgical ligatures.
1.2 This
standard does not cover antimicrobial impregnated non -absorbable sutures.
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: Consumer information, labelling; Quality requirements;
Harmonization; Reducing trade barriers and facilitating trade
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8.
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Relevant
documents:
1. ISO 10993 (all parts), Biological evaluation of medical
devices
2. ISO
15223-1, Medical devices - Symbols to be
used with medical device labels, labelling and information to be supplied -
Part 1: General requirements.
3. ISO 24153, Random sampling and randomization procedures
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9.
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Proposed
date of adoption: To be determined
Proposed date of entry into force: To be determined
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10.
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Provision of comments
Final
date for comments: 16 September
2025
[X] 60 days from notification
Contact details of agency or authority designated to handle comments
regarding the notification:
Standards
Organisation of Nigeria,
Chudi-Anaukwu,
Chioma Vivienne
52 Lome
crescent Wuse zone 7, Abuja.
Tel: +(234)
803 316 2789; +(234) 809 716 7219
Email: wto.tbt.nep@son.gov.ng
chivivlinjet@yahoo.com
Website:
http://www.son.gov.ng
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