G/TBT/N/RWA/406  
20 November 2020  
(20-8370) 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:  RWANDA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Rwanda Standards Board (RSB)  
KK 15 Rd, 49  
P.O.BOX 7099, Kigali, Rwanda  
Tel: +250 788303492  
Email: info@rsb.gov.rw   
Website: www.rsb.gov.rw  
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):  Hospital 
equipment (ICS 11.140)  
5. Title, number of pages and language(s) of the notified document:  DRS 440: 2020 
Surgical clothing and drape s — Specification (19 page(s), in English)  
6. Description of content:  This Draft Rwanda Standard specifies the requirements, 
sampling and test methods for surgical drapes, single -use and reusable gowns,clean air 
suits and drapes used as medical consumable s for patients, clinical staff and equipment 
to prevent the transmission of infective agents between clinical staff and patients during 
surgical and other invasive procedures.  
This standard does not cover requirements for resistance to penetration by laser  radiation 
of products and it is not applicable to incision drapes or films, isolation gowns and 
decontamination gowns.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Protection of the 
environment; Quality requirements; Reducing trade barriers and facilitating trade  
8. Relevant documents:   
• RS ISO 139, Textiles — Standard atmospheres for conditioning and testing  
• ISO 2859 -1, Sampling procedures for inspection by attributes — Part 1: Sampling 
schemes indexed by acceptance quality limit (AQL) for lot -by-lot inspection  G/TBT/N/RWA/406  
 
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  • ISO 9073 -10, Textiles - Test methods for nonwovens - Part 10: Lint and other 
particles generation in the dry state  
• ISO 9073 -18, Textiles — Test methods for nonwovens — Part 18: Determination 
of breaking strength and elongation of nonwoven materials using the grab tensi le 
test 
• ISO 10993 -1, Biological evaluation of medical devices - Part 1: Evaluation and 
testing within a risk management process  
• ISO 10993 -10, Biological evaluation of medical devices — Part 10: Tests for 
irritation and skin sensitization  
• ISO 11737 -1, Steri lization of medical devices — Microbiological methods — 
Part 1: Determination of a population of microorganisms on products  
• ISO 12952 -2, Textiles — Assessment of the ignitability of bedding items — Part 2: 
Ignition source: matchflame equivalent  
• RS ISO 1368 8, Protective clothing — General requirements  
• ISO 13938 -1, Textiles - Bursting properties of fabrics - Part 1: Hydraulic method 
for determination of bursting strength and bursting distension  
• ISO 22610, Surgical drapes, gowns and clean air suits, used as me dical devices, 
for patients, clinical staff and  equipment - Test method to determine the 
resistance to wet bacterial penetration  
• ISO 22612, Clothing for protection against infectious agents - Test method for 
resistance to dry microbial penetration  
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:   
KK 15 Rd, 49  
Toll Free: 3250  
Tel: +250 788303492  
Email: info@rsb.gov.rw  
Website: www.rsb.gov.rw  
P.O.BOX 7099, Kigali, Rwanda  
https://members.wto.org/crnattachments/2020/TBT/RWA/20_7145_00_e.pdf