Brazilian Health Surveillance Agency  
www.anvisa.gov.br  
  
Draft Resolution No  12 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 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 18 January 2010,  
hereby adopts the following Draft Resolu tion, 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 layi ng down minimum identity and quality requirements for single -
use sterile hypodermic syringes made of plastic, intended for the suction of fluids or the 
injection of fluids immediately after filling either manually or using a syringe pump, as 
detailed in th e 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 Gera l 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 that they may 
appoint representatives for subsequent discussions with a view to consolidating the final 
text. 
DIRCEU RAPOSO DE MELLO  
ANNEX  
COLLEGIATE DIRECTORATE  RESOLUTION No … of … 2009  
Laying down minimum requirements of identity and quality for single -use sterile 
hypodermic syringes made of plastic, intended for the suction of fluids or the injection of 
fluids immediately after filling either manually or using  a syringe pump.  
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 
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  Where as 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;1  
Having regard to the notifications received in relation to problems with the quality of 
single -use sterile hypodermic syringes;  
Having regard to the need to establish minimum requirements for single -use sterile 
hypodermic needles in order to guarantee their 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 single -use sterile hypodermic syringes made of plastic, intended 
for the suction of fluids or the injection of fluids  immediately after filling either manually 
or using a syringe pump, as specified in the Annex.  
Article 2 – single -use sterile hypodermic syringes made of plastic, intended for the 
suction of fluids or the injection of fluids immediately after filling eithe r manually or 
using a syringe pump must also meet the conformity certification requirements laid down 
by the Brazilian Conformity Assessment System.  
Sole paragraph: Brazilian manufacturers and importers may choose certification by 
system assessment  and pr oduct testing or by assessment on a batch -by-batch basis.  
Article 3 – Companies 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 RAPOS O DE MELLO  
ANNEX  
TECHNICAL REGULATION LAYING DOWN MINIMUM IDENTITY AND 
QUALITY REQUIREMENTS FOR SINGLE -USE HYPODERMIC SYRINGES  
1. OBJECTIVE  
To lay down minimum identity and quality requirements for single -use sterile 
hypodermic syringes made of plastic, in tended for the suction of fluids or the injection of 
fluids immediately after filling either manually or using a syringe pump.  
The provisions laid down herein shall not apply to syringes made of glass.  
2. DEFINITIONS:  
The following definitions shall apply for the purposes of this Regulation:  
2.1 Normal capacity – syringe capacity declared by the manufacturer.  
2.2 Maximum capacity – syringe capacity when the piston is raised to the farthest 
position out of the syringe.  2.3 Needle cap – protective cap at the end of the needle intended to maintain the 
sterility of the needle's cannula and physically to protect the cannula and the base of the 
needle, where applicable.  
2.4 Needle protector – cap intended to protect the needle's cannula.  
2.5 End-protector caps: ca ps intended to cover the protruding part of the rod and the 
base of the plunger, at one end, and the nozzle or needle, at the other end.  
3. CLASSIFICATION  
Single -use sterile hypodermic syringes shall be classified as follows:  
3.1. for manual use;  
3.2. for use in a syringe pump; and  
3.3. for insulin.  
4. DESIGNATION  
  
Syringes shall be designated as follows: "Single -use sterile hypodermic syringe for 
manual use" or "Single -use sterile hypodermic syringe for use with a pump" or "Single -
use sterile hypodermic syringe for insulin with or without a needle".  
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, Intermini sterial 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 b etween 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 applicable to the health pr oducts 
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, ANVISA RDC No  207 of 17 N ovember 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 No  59 of 27 June 2000. Technical Resolution laying 
down essential 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.  
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 Characteristics, 1985.  
5.9 Brazil, ABNT, NBR ISO No  7886 -1:2003, approving the Br azilian standard for 
single -use sterile hypodermic syringes, Part 1: syringes for manual use.  
5.10 Brazil, ABNT, NBR ISO No  7886 -2:2003, approving the Brazilian standard for 
single -use sterile hypodermic syringes, Part 2: syringes for use with power -driven  
syringe pumps.  
5.11 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.  
5.12 Brazil, Brazilian Technical Standards Association, NBR No  594:-2:200 3, Conical 
fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment, 
Part 2 – Fixed Assembly.  
5.13 Brazil, ABNT, NBR ISO No  8537:2006, approving the Brazilian Standard for 
sterile single -use syringes, with or without needle, for insulin.  
6. GENERAL PRINCIPLES  
6.1. Manufacturers of single -use sterile hypodermic syringes for manual use or with 
syringe pumps must operate under the established Boas Práticas de Fabricação – BFP  
(Good Manufacturing Practices).  
6.2. Materials used in  the manufacture of single -use sterile hypodermic syringes for 
manual use or with syringe pumps must be compatible with the not alter their physical or 
chemical properties.  
6.3. Single -use sterile hypodermic syringes for manual use or with power -driven 
syringe pumps must be free of contaminants that may pose a risk to human health.  
6.4. Manufacturers of single -use sterile hypodermic syringes for manual use or with 
power -driven syringe pumps must demonstrate that the syringe and the pump are 
mutually compati ble. 
6.5. Single -use sterile hypodermic syringes for manual use or with power -driven 
syringe pumps must be lubricated and graduated.  
7. MINIMUM REQUIREMENTS:  
7.1. Single -use sterile hypodermic syringes for manual use or with power -driven 
syringe pumps must  meet the provisions laid down in the Brazilian Standards, 
corresponding to the following requirements:  
7.1.1.  Physical tests:  
7.1.1.1.  Cleaning conditions;  7.1.1.2.  Presence of lubricant;  
7.1.1.3.  Compatibility of the declared volume;  
7.1.1.4.  Measurement  of the graduated scale;  
7.1.1.5.  Dimensions of the syringe cylinder;  
7.1.1.6.  Compatibility of the piston/plunger;  
7.1.2.  Chemical tests:  
7.1.2.1.  Presence of extractable metals;  
7.1.2.2.  Residual presence of ethylene oxide;  
7.1.2.3.  Acidity and alkalinit y rates;  
7.1.2.4.  Reducers (oxidants);  
7.1.2.5.  Metal ions;  
7.1.2.6.  Alkalinity and acidity;  
7.1.3.  Biological tests:  
7.1.3.1.  Toxicity;  
7.1.3.2.  Sterility;  
7.1.3.3.  Pyrogenicity.  
7.2. The tests to be performed, and the procedures and methods of analysis t o be 
followed, shall be those described in the Brazilian Standards applicable to the product.  
8. PACKAGING AND LABELLING  
8.1 – Single -use sterile hypodermic syringes for manual use or with power -driven 
syringe pumps must be –packaged individually.  
8.2 – Packaging must be such that gravity drip infusion equipment for use with 
pressurised infusion and transfusion pumps remains intact, in particular in order to 
maintain the sterility of the contents.  
  
8.3 – The unit packaging of single -use sterile hypodermic syringes for manual use or 
with power -driven syringe 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 single -use sterile hypodermic syringes for manua l 
use or with power -driven syringe pumps must comply with the requirements laid down in 
the relevant Brazilian Standards and with the health legislation applicable to medical 
devices.  
9. SAMPLING  9.1 – The sampling plans, special inspection levels and acce ptable quality levels 
applicable to single -use sterile hypodermic syringes for manual use or with power -driven 
syringe pumps must be those laid down in the Brazilian Standards. 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 - single -use sterile hypodermic syringes for manual use or with power -driven 
syringe pumps must be packaged in such a way that they are protected and remain intact 
from their manu facture to their end use.  
11. STORAGE  
11.1 - Single -use sterile hypodermic syringes for manual use or with power -driven 
syringe pumps must be stored and transported in conditions that ensure that they are 
unaffected, in particular, by heat, humidity and li ght.