Updated INMETRO Ordinances for Syringes and Syringe Pumps

The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) recently published an update and consolidation of the conformity assessment requirements for single-use sterile hypodermic syringes for gravitational infusion and single-use transfusion equipment for use with infusion pumps. INMETRO issued these updates through ordinances 458 and 461 in November 2021.

Sterile hypodermic syringes are made of single-use plastic and are intended for the manual injection of insulin or use with an insulin pump. These syringes may also be used with transfusion, gravitational infusion and infusion pump sets, subject to assessment and review. 

Review these important changes

The updated ordinances outline various adjustments to existing standards, such as:

• Update of the RDC – Resolution of the Collegiate Board of ANVISA and applicable technical standards
• Clarifications on the common characteristics for the formation of families and notation in the description of the products in the Certificate of Conformity
• Clarifications regarding the evaluation of kits and sets of approved products
• Alteration of the INMETRO Conformity Identification Seal with a deadline for adaptation
• Change of responsibility for affixing the Conformity Identification Seal on the product

The updated ordinances went into effect on Dec. 1, 2021. Products with existing certification must be evaluated for compliance to the new standards during the next stage of evaluation, such as maintenance or recertification.

Manufacturers and importers have 60 months to update the Conformity Identification Seal. 

How to adapt products for updated standards

With locations and experts in Brazil, UL can help manufacturers, importers and suppliers who need to recertify products to updated INMETRO standards, from identifying applicable requirements to assembling technical files and more.

Contact us at healthsciencesla@ul.com to learn about UL’s complete solution.