INSTRUÇÃO NORMATIVA N° 57, DE 20 DE DEZEMBRO DE 2019
Data de publicação | 26 Dezembro 2019 |
Data | 20 Dezembro 2019 |
Páginas | 131-131 |
Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,Diretoria Colegiada |
Seção | DO1 |
INSTRUÇÃO NORMATIVA N° 57, DE 20 DE DEZEMBRO DE 2019
Dispõe sobre requisitos sanitários para a garantia da qualidade e da segurança em sistemas de radiologia odontológica intraoral, e dá outras providências.
A Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso das atribuições que lhe confere o art.15, III e IV, aliado ao art. 7º, III e IV, da Lei n.º 9.782, de 26 de janeiro de 1999, e ao art. 53, VI, nos §§ 1º e 3º do Regimento Interno aprovado pela Resolução da Diretoria Colegiada - RDC n° 255, de 10 de dezembro de 2018, em reunião realizada em 17 de dezembro de 2019, resolve:
CAPÍTULO I
DAS DISPOSIÇÕES INICIAIS
Art. 1º Esta Instrução Normativa estabelece requisitos sanitários para a garantia da qualidade e da segurança em sistemas de radiologia odontológica intraoral, bem como a relação mínima de testes de aceitação e de controle de qualidade que devem ser realizados pelos serviços de saúde, determinando respectivas periodicidades, tolerâncias e níveis de restrição, conforme Anexo I desta Instrução Normativa.
Parágrafo único. O rol de testes do Anexo I desta Instrução Normativa deve ser complementado pelos testes de aceitação e de controle de qualidade estabelecidos pelo fabricante do sistema avaliado.
Seção I
Das características dos equipamentos
Art. 2º Todo equipamento de raios X odontológico intraoral deve possuir:
I - Tensão nominal no tubo de raios X maior ou igual a 60 kVp (sessenta quilovolts de pico);
II - Filtração total permanente não inferior ao equivalente a 1,5 mm (um inteiro e cinco décimos de...
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