Brazilian Health Surveillance Agency  
www.anvisa.gov.br  
  
Draft Resolution No  11 of 27  January 2010.  
Brazilian Official Gazette ( Diário Oficial da União  – DOU) of 1  February 2010  
The Collegiate Directorate of the Agência Nacional de Vigilância Sanitária  – ANVISA 
(Brazilian Health Surveillance Agency), pursuant to the powers conferred on it by Article 
11(IV) and Article 35 of the ANVISA Regulation approved by Decree No  3029 of 16 
April 1999, and having regard to the provisions of Item V and points 1 and 3 o f Article 
54 of the Internal Regulations approved in accordance with Annex I of ANVISA 
Administrative Ruling No  354 of 11 August 2006, republished in the DOU of 21 August 
2006, at a meeting held on 18 January 2010,  
hereby adopts the following Draft Resolut ion, and I, the Director -President, order its 
publication:  
Article 1 – A period of sixty days from the date of publication of this Draft Resolution is 
hereby declared open for submitting criticisms and suggestions on the draft Technical 
Regulation laying d own minimum identity and quality requirements for infusion sets for 
single use, gravity feed, for use with infusion and transfusion pumps, as detailed in the 
Annex.  
Article 2 – This full proposal will be available during the consultation period at 
www.anvisa.gov.br  and any suggestions should be sent in writing to: Agência Nacional 
de Vigilância Sanitária, Gerência Geral de Tecnologia de Produtos para Saúde, S.I.A., 
Trecho 5, Lote Especial 57, Brasília – DF – 71.205 -050, Brazil, by fax (061) 3462 -6644 
or by email to tecnologia.produtos@anvisa.gov.br.  
Article 3 – At the end of the period stipulated in Article 1, the ANVISA will make 
contact with the interested parties and others who have expressed interest in order tha t 
they may appoint representatives for subsequent discussions with a view to consolidating 
the final text.  
DIRCEU RAPOSO DE MELLO  
ANNEX  
COLLEGIATE DIRECTORATE RESOLUTION (RDC) No … of … 2009  
Laying down minimum identity and quality requirements for infusio n sets for single use, 
gravity feed, for use with infusion and transfusion pumps.  
The Collegiate Directorate of the Brazilian Health Surveillance Agency, pursuant to the 
powers conferred on it by Article 11(IV) and Article 35 of the ANVISA Regulation 
appro ved by Decree No  3029 of 16 April 1999, and having regard to the provisions of 
Item V and points 1 and 3 of Article 54 of the Internal Regulations approved in 
accordance with Annex I of ANVISA Administrative Ruling No  354 of 11 August 2006, 
republished in the DOU of 21 August 2006, at a meeting held on [date], and  Whereas the Ministry for Health established a quality assurance system for related 
products by adopting the Brazilian Conformity Assessment System with a view to 
assuring the safety and quality of  such materials;  
Having regard to the notifications received in relation to problems with the quality of 
infusion sets for single use, gravity feed, for use with infusion and transfusion pumps;  
Having regard to the need to establish minimum requirements fo r infusion equipment in 
order to guarantee its quality, safety and effectiveness, and to protect consumers, hereby 
decides:  
  
Article 1 – To approve the Technical Regulation laying down minimum identity and 
quality requirements for infusion sets for single  use, gravity feed, for use with infusion 
and transfusion pumps, as detailed in the Annex.  
Article 2 – Infusion sets for single use, gravity feed, for use with infusion and transfusion 
pumps must also meet the conformity certification requirements laid dow n by the 
Brazilian Conformity Assessment System.  
Sole paragraph: Brazilian manufacturers and importers may choose certification by 
system assessment and product testing or by assessment on a batch -by-batch basis.  
Article 3 – Companies have 180 days in whic h to adjust to the provisions laid down in 
this Resolution.  
Article 4 – This Resolution shall enter into force on the date of its publication.  
DIRCEU RAPOSO DE MELLO  
ANNEX  
TECHNICAL REGULATION LAYING DOWN MINIMUM IDENTITY AND 
QUALITY REQUIREMENTS FOR INFUS ION EQUIPMENT  
1. OBJECTIVE:  
To lay down minimum identity and quality requirements for infusion sets for single use, 
gravity feed, for use with infusion and transfusion pumps.  
2. DEFINITIONS:  
The following definitions shall apply for the purposes of this Re gulation:  
2.1. Gravity -feed infusion set – single -use, sterile, non -pyrogenic device for 
intravenous infusions. Such equipment must be compatible with solution infusion 
containers and intravenous devices.  
2.2. Infusion equipment for use with infusion pump – single -use, sterile, non -
pyrogenic device for intravenous infusions that must be coupled with a pressure infusion 
pump. Such equipment must be proven to be compatible with the pump.  
 2.3. Transfusion equipment – single -use, sterile, non -pyrogenic device for blood 
transfusions. Such equipment must be compatible with packaging receptacles for blood 
and blood components, intravenous catheters and cannulas.  
2.4. (Pressure) infusion pump – equipment for regulating the flow of liquids delivered 
to patients, und er positive pressure from the pump.  
3. CLASSIFICATION  
Infusion equipment is classified according to:  
3.1. - its use: gravity -feed, for use with transfusion and infusion pumps  
3.2. its compatibility: for use with pressure (specify) transfusion and infusion  pumps 
for gravity -feed use.  
4. DESIGNATION  
The equipment shall be designated as follows: "Gravity -feed infusion set" or "Infusion 
set for gravity -feed use"; "Infusion equipment for use with infusion pump"; "Transfusion 
equipment".  
All of the above designa tions must be preceded by the words "single -use" and 
"sterilised".  
  
5. REFERENCES  
5.1 BRAZIL. Act No  8 078 of 11 September 1990. Consumer Protection Code. 
Diário Oficial da União  – DOU (Brazilian Official Gazette), Brasília, 12 September 
1990. Supplement.  
5.2 BRAZIL, Interministerial Order MS/MIDC No  692 of 8  April 2009, defining the 
implementation of technical cooperation for the quality and safety assurance of medical 
devices, subject to the health inspection arrangements, as laid down in the Technical 
Cooperation Agreement between the Health Ministry (MS) and the Ministry for 
Development, Industry and External Trade (MDIC).  
5.3 BRAZIL, ANVISA RDC No  56 of 6 April 2001. Technical Resolution laying 
down essential safety and effectiveness requirements appli cable to the health products 
referred to in the Annex to this Resolution, DOU Brasília, Government, of 10  April 2001.  
5.4 BRAZIL, ANVISA RDC No  185 of 22 October 2001. Technical Regulation 
concerning the registration, amendment, renewal and cancellation of  the registration of 
medical products with the ANVISA, DOU Brasília, Government, of 6 November 2001.  
5.5 BRAZIL, ANVISA RDC No  156 of 11 August 2006, on the registration, 
labelling and re -processing of medical products and other provisions.  
5.6 BRAZIL, ANV ISA RDC No  207 of 17 November 2006, amending Resolution 
No 185, concerning the registration, amendment, renewal and cancellation of the 
registration of medical products with the ANVISA, DOU Brasília, Government, of 6 
November 2001.  5.7 BRAZIL, ANVISA RDC N o 59 of 27 June 2000. Technical Resolution laying 
down essential safety and effectiveness requirements applicable to health products, 
compliance with the requirements of Boas Práticas de Fabricação de Produtos Médicos  
(Good Practice in the Manufacture of M edical Products). DOU Brasília, Government, of 
29 June 2000.  
5.8 Brazil, Associação Brasileira de Normas Técnicas  – ABNT ( Brazilian Technical 
Standards Association), NBR No  5426:1985, approving Sampling Plans and Procedures 
for the Inspection of Characteri stics, 1985.  
5.9 Brazil, ABNT, NBR No  8536 –4:2008, Infusion equipment for medical use – Part 
4: Infusion equipment for individual use, gravity feed.  
 
5.10 INTERNATIONAL ORGANIZATION FOR STARDARDIZATION – ISO, ISO 
8536 – 8:2004 – Infusion equipment for medi cal use – Part 8:  Infusion equipment for use 
with pressure infusion apparatus.  
5.11 INTERNATIONAL ORGANIZATION FOR STARDARDIZATION – ISO, ISO 
594-2:2003 – Conical fittings with 6% (Luer) taper for syringes, needles and certain 
other medical equipment – Part 2: Lock fittings.  
5.12 INTERNATIONAL ORGANIZATION FOR STARDARDIZATION – ISO, ISO 
1135 – 4:2004 – Transfusion equipment for medical use – Part 4:  Transfusion sets for 
single use.  
5.13 INTERNATIONAL ELECTROTECHNICAL COMMISSION – IEC, IEC 60601 
2-24:1999, M edical electrical equipment – Part 2 -24: Particular requirements for the 
safety of inclusion pumps and controllers.  
6. GENERAL PRINCIPLES  
6.1. Manufacturers of infusion sets, gravity feed, for use with pressure infusion and 
transfusion pumps must observe t he Boas Práticas de Fabricação - BPF (Good 
Manufacturing Practices).  
6.2. Infusion sets, gravity feed, for use with pressure infusion and transfusion pumps 
must not pose a risk to the patient.  
6.3. The materials used for manufacturing infusion sets, gravit y feed, for use with 
pressure infusion and transfusion pumps must not alter the solutions passing through it.  
  
6.4. Infusion sets, gravity feed, for use with pressure infusion and transfusion pumps 
must be:  
6.4.1.  free of contaminants that may pose a risk  to human health; and  
6.4.2.  manufactured from flexible, non -toxic materials.  
7. MINIMUM REQUIREMENTS:  7.1. Infusion sets, gravity feed, for use with pressure infusion and transfusion pumps 
must meet the following requirements:  
7.1.1.  Physical tests:  
7.1.1 .1. Integrity;  
7.1.1.2.  Stress in the connection between the component and the tube;  
7.1.1.3.  Penetrative tip;  
7.1.2.  Chemical tests:  
7.1.2.1.  Reducers (oxidants);  
7.1.2.2.  Metal ions;  
7.1.2.3.  Alkalinity and acidity;  
7.1.3.  Biological tests:  
7.1.3.1.  Toxi city; 
7.1.3.2.  Sterility;  
7.1.3.3.  Pyrogenicity.  
7.2. The tests to be performed, and the procedures and methods of analysis to be 
followed, shall be those described in the Brazilian Standards applicable to the product.  
8. PACKAGING AND LABELLING  
8.1 – Infu sion sets, gravity feed, for use with pressure infusion and transfusion pumps 
must be packaged individually.  
8.2 – Packaging must be such that infusion sets, gravity feed, for use with pressure 
infusion and transfusion pumps remain intact, in particular in  order to maintain the 
sterility of the contents.  
8.3 – The unit packaging of infusion sets, gravity feed, for use with pressure infusion 
and transfusion pumps must show clear evidence, when open, that it has indeed been 
opened and that it cannot be re -sealed after opening.  
8.4 – The wording on labelling of infusion sets, gravity feed, for use with pressure 
infusion and transfusion pumps must comply with the requirements laid down in the 
relevant Brazilian Standards and with the health legislation applicabl e to medical 
devices.  
9. SAMPLING  
9.1 – The sampling plans, special inspection levels and acceptable quality levels 
applicable to infusion sets, gravity feed, for use with pressure infusion and transfusion 
pumps must be those laid down in the Brazilian Sta ndards. In the case of suspicion or 
notification of deficiencies in one or more batches, the ANVISA may demand more 
stringent inspection levels.  10. PACKAGING  
  
10.1 - Gravity drip infusion equipment for use with pressure infusion and transfusion 
pumps mus t be packaged in such a way that it is protected and remains intact from its 
manufacture to its end use.  
11. STORAGE  
11.1 - Gravity drip infusion equipment for use with pressure infusion and transfusion 
pumps must be stored and transported under conditions  that ensure that it is unaffected, 
in particular, by heat, damp and light.