Brazilian Health Surveillance Agency  
www.anvisa.gov.br  
  
Draft Resolution No  10 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 proposed 
Technical Regulation layin g down minimum identity and quality requirements for sterile 
hypodermic needles for single use, 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 e mail 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 that 
they may appoint representatives for subs equent 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 sterile hypodermic needles 
for single use.  
The Co llegiate Directorate of the National 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 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 Hea lth 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 wit h the quality of 
sterile hypodermic needles for single use;  
Having regard to the need to establish minimum requirements for 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 sterile hypodermic needles for single use, as specified in the 
Annex.  
Article 2 – Sterile hypodermic needles for single use must also meet the conformity 
certifi cation requirements laid down 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 – Com panies have 180 days in which 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  
ANEXO  
TECHNICAL REGULATION LAYING DOWN MINIMUM IDENTITY AND 
QUALITY REQUIREMENTS FOR STERILE HYPODERMIC NEEDLES FOR 
SINGLE USE  
1. OBJECTIVE: To lay down minimum identity and quality requirements for sterile 
hypodermic needles for single use.  
2. DEFINITIONS: The following definitions shall apply for the purposes of th is 
Regulation:  
 
2.1 Cannula – Stainless steel tube of specified dimensions, with a bevel at one end.  
2.2 Lock – Link made of plastic, aluminium alloy or other alloy, enabling the needle 
to be coupled to the syringe or any male Luer connector.  
2.3 Needle – Cannula firmly fitted into the lock.  
2.4 Protector – Accessory adaptable to the lock, intended to protect the cannula.  
2.5 Bevel – sharp, cutting part of the cannula.  
 3. DESIGNATION. The designation of the needle shall be: "Single -use sterile 
hypodermic n eedle".  
4. REFERENCES  
4.1 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.  
4.2 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).  
4.3 Brazil, ANVISA RDC No  56 of 6  April 2001. Technical Resolution laying down 
essential safety and effectiveness requirements applicable to the health products referred 
to in the Annex to this Resolution, DOU Brasília, Government, of 10  April 2001.  
4.4 BRASIL 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 Bras ília, Government, of 6 November 2001.  
  
4.5 Brazil, ANVISA RDC No  156 of 11 August 2006, on the registration, labelling 
and re -processing of medical products and other provisions.  
4.6 BRASIL ANVISA 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.  
4.7 Brazil, ANVISA RDC No  59 of 27 June 2000. Technical Resolution laying down 
essenti al safety and effectiveness requirements applicable to health products, compliance 
with the requirements of "Good Practice in the Manufacture of Medical Products" DOU 
Brasília, Government, of 29 June 2000.  
4.8 Brazil, Brazil, Associação Brasileira de Norma s Técnicas  – ABNT (Brazilian 
Technical Standards Association), NBR No  5426:1985, approving Sampling Plans and 
Procedures for the Inspection of Characteristics, 1985.  
4.9 Brazil, ABNT, NBR No  9259:1997, approving the Brazilian Standard for sterile 
hypodermi c needles for single use.  
 
4.10 Brazil, ABNT, NBR No  9626:2003, approving the Brazilian Standard for 
stainless steel tubes for needles for the manufacture of medical devices.  
4.11 Brazil, ABNT, NBR No  5601:1981, approving the Brazilian Standard for 
stainle ss steel – classification by chemical composition - Standardisation.  
4.12 Brazil, ABNT, NBR No  594-1:2003, Conical fittings with 6% (Luer) taper for 
syringes, needles and certain other medical equipment, Part 1 – General Requirements.  4.13 Brazil, ABNT, NB R No  594-2:2003, Conical fittings with 6% (Luer) taper for 
syringes, needles and certain other medical equipment, Part 2 – Fixed Assembly.  
4.14 INTERNATIONAL ORGANIZATION FOR STARDARDIZATION – ISO, ISO 
7864:1993 – Sterile hypodermic needles for single use.  
5. GENERAL PRINCIPLES  
5.1. Manufacturers of sterile hypodermic needles for single use must observe the Boas 
Práticas de Fabricação – BPF (Good Manufacturing Practices).  
5.2. Materials used in the manufacture of sterile hypodermic needles for single use 
must be compatible with fluids to be injected and must not alter their physical or 
chemical properties.  
5.3. Sterile hypodermic needles for single use must be free of contaminants that may 
pose a risk to human health.  
5.4. Manufacturers of sterile hypodermic  needles for single use must demonstrate that 
the needles are compatible with syringes.  
5.5. Sterile hypodermic needles for single use may be externally lubricated.  
 
5.6 Cannulas of sterile hypodermic needles for single use must be straight and 
tubular, wi th a circular cross -section, and with an angular displacement of no more than 
three degrees. The outer surface must be clean, entirely smooth and free of 
protuberances.  
5.7 The tubes of sterile hypodermic needles for single use must be made from 
stainless steel for the manufacture of medical devices, as defined in the applicable 
Standards.  
6. MINIMUM REQUIREMENTS:  
6.1. Sterile hypodermic needles for single use must meet the following requirements: 
6.1.1. Physical tests:  
  
6.1.1.1.  Materials for using the ca nnula and the lock;  
6.1.1.2.  Cleanliness conditions;  
6.1.1.3.  Presence of lubricant;  
6.1.1.4.  Strength of the protector;  
6.1.1.5.  Rigidity;  
6.1.1.6.  Sealing of the junction between the cannula and the lock;  
6.1.1.7.  Safety of the junction between the cannu la and the lock;  
6.1.1.8.  Breaking strength;   
6.1.2.  Chemical tests: 6.1.2.1. Corrosion resistance;  
6.1.3.  Biological tests:  
 
6.1.3.1.  Toxicity;  
6.1.3.2.  Sterility;  
6.1.3.3.  Pyrogenicity.  
6.2. Tests, procedures and methods of analysis are those described i n the Brazilian 
Standards applicable to the product.  
7. PACKAGING AND LABELLING  
7.1 – Sterile hypodermic needles for single use must be placed in plastic protectors 
and packaged individually.  
7.2 – Packaging must be such that single -use sterile hypodermic syringes for manual 
use or use with a syringe pump remain intact, especially in order to maintain the sterility 
of the content.  
7.3 – The individual packaging of sterile hypodermic needles for single use must 
show clear evidence, when open, that it has ind eed been opened and that it cannot be re -
sealed after opening.  
7.4 – The wording on labelling of sterile hypodermic needles for single use must 
comply with the requirements laid down in the corresponding Brazilian Standards and 
with the health legislation applicable to medical devices.  
8. SAMPLING  
8.1 – The sampling plans, special inspection levels and acceptable quality levels 
applicable to single -use sterile hypodermic syringes for manual use or use with a syringe 
pump must be those laid down in the Brazi lian Standards. In the event of suspicion or 
notification of deficiencies in one or more batches, the ANVISA may demand more 
stringent inspection levels  
9. PACKAGING  
9.1 – Sterile hypodermic needles for single use must be packaged in such a way that the 
product is protected and remains intact from its manufacture to its end use.  
10. STORAGE  
10.1 – Sterile hypodermic needles for single use must be stored and transported under 
conditions that ensure that it is unaffected, in particular, by heat, humidity and light.