Certification of sterile hypodermic

Certification of sterile hypodermic needles for single use and sterile gingival needles for single use.

Inmetro Ordinance No. 84, of February 10, 2021, establishes the criteria and procedures for evaluating the conformity of sterile hypodermic needles for single use and sterile gingival needles for single use, under a Health Surveillance regime, with a focus on health. The conformity assessment mechanism is certification, using the following models:

· Certification Model 5: Initial assessment consisting of tests on samples taken from the manufacturer, including auditing of the Quality Management System (QMS), followed by periodic maintenance assessment through the collection of samples of the product in the trade, to carry out the activities of compliance assessment and QMS audit;
· Certification Model 1b – Batch test.

The certification process follows the steps below:

· Collection of samples for testing;
· Evaluation of test reports;
· Conducting QMS audit and complaint handling audit;
· Final analysis and certification decision.

The conformity identification seal is shown below: