National Institute of Quality Control in Health/Oswwaldo Cruz Foundation,
Chemistry, 4365, Manguinhos, Rio de Janeiro, Rio de Janeiro 21040900
Brazil
Research Article
Products Sanitary Surveillance: Latex Condom on the Bias of the Sanitary Risk
Author(s): Janete Teixeira DuarteJanete Teixeira Duarte
Objective: Health products can be marketed in Brazil after registration in the Health Ministry. Male condoms are considered health products and are compulsorily certified following RDC 62/2008 regulation. Condom sanitary control must follow the certification regulation however is impractical due to great sample size (548 units for each lot). An appropriate technical surveillance should be designed to condom sanitary control. Methods: Two different batches were purchased directly from the manufacturer. And three different brands, being one of them similar to the batches acquired directly from the manufacturer, were acquired in several establishments in Brazil, and the total amount was the sum of several different lots for each of the chosen brands. It was incorporated geoprocessing technique to maintain the traceability of the lots collected in the trade. Analyzes were performed accor.. Read More»
DOI:
10.4172/2155-6113.1000700
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