. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/363 
23 February 2010  
 (10-0968) 
Committee on Technical Barriers to Trade Original:   English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance Agency – ANVISA 
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 :   
National Institute of Metrology, Standa rdization and Industrial Quality-INMETRO 
Tel.:  +(55) 21 25632821 
Fax:  +(55) 21 25026542 Email:  barreirastecnicas@inmetro.gov.br Website:  http://www.inmetro.gov.br/barreirastecnicas
 
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):  Infusion sets for single 
use.  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 11, 
27 January 2010 – infusion sets for si ngle use (5 pages, Portuguese). 
6. Description of content:  This technical regulati on establishes the minimum requirements of 
identity and quality of infusion sets for single use: for use with infusion and transfusion pumps, as specified in the Annex of the Resolution.  
Infusion sets for single use: for use with infusion  and transfusion pumps -  must also meet the 
requirements for certif ication under the Brazilian Confor mity Assessment System (SBAC). 
According to the paragraph of Art. 2,  dome stic manufacturers and importers may choose the 
type of certification under the SBAC.  
The companies have a period of 180 days to adequate to the Resolution, after its entry into 
force.  
The Resolution is based on the following In ternational Standards:  ISO 8536 - 8:2004 – 
Infusion equipment for medical use – part 8:  infusion equipment for use with pressure 
infusion apparatus; ISO 594-2:2003 – conical fi ttings with 6% (Luer) taper for syringes, 
needles and certain other medi cal equipment – part 2: Lo ck fittings; ISO 1135 – 4:2004 – 
Transfusion equipment for medical use – part 4: transfusion sets fo r single use; IEC 60601 2-
24:1999 – medical electrical equipment – part 2-24 : particular requirements for the safety of 
inclusion pumps and controllers.  G/TBT/N/BRA/363 
Page 2  
 
  It is also based on the following standard s: ABNT, NBR Nº 5426: 1985;  ABNT, NBR ISO 
Nº 8536 – 4:2008. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da União), 1 February 2010; 
Section 1. Draft Resolution (Consulta Públic a) number 11, 27 January 2010, issued by 
Brazilian Sanitary Surveillance Agency – A nvisa; When adopted, it will be published at 
Brazilian Official Journal. Available in Portuguese.   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period.  
On the date of adoption. 
10. Final date for comments:  1 April 2010 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
National enquiry point 
Agency responsible Brazilian Sanitary Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil 
CEP:  71.205-050 
Phone:  55 61 3462 5402 E-mail:  rel@anvisa.gov.br  Website:  http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br/wps/wcm/conn ect/c751578041388de8bc3c bdc5ae04202e/CP+N
%C2%BA+11+GGTPS.pdf?MOD=AJPERES