Traceability from governmental producers of radiopharmaceuticals in measuring 18 F in Brazil A.E. Oliveira a,n , A Iwahara a , C. J Silva a , P.A. L Cruz a , R Poledna a , R. L Silva a , A.S. Laranjeira a , J.U. Delgado a , L. Tauhata a , J. S Loureiro a , B C Toledo a , A.M.S. Braghirolli b , E.A.L. Andrade b , J.L. Silva b , H.O.K. Hernandes b , E.S. Valente c , H.M. Dalle c , V.M. Almeida d , T.G. Silva d , M.C.F. Fragoso d , M.L. Oliveira d , E.S.S. Nascimento d , E.M. Oliveira e , R. Herrerias e , A.A. Souza e , E. Bambalas e , W.A. Bruzinga e a Laboratório Nacional de Metrologia das Radiações Ionizantes (LNMRI)/Instituto de Radioproteção e Dosimetria (IRD)/Comissão Nacional de Energia Nuclear (CNEN), Av. Salvador Allende s/n, 22780-160 Recreio CEP Rio de Janeiro, Brazil b Instituto de Engenharia Nuclear (IEN)/Comissão Nacional de Energia Nuclear (CNEN), Cidade Universitária, Ilha do Fundão, n Caixa Postal 68550, CEP 21945-970 Rio de Janeiro, Brazil c Centro de Desenvolvimento da Tecnologia Nuclear (CDTN)/CNEN, Avenida Presidente Antônio Carlos, 6.627-Campus UFMG, CEP 31270-901-Caixa Postal 941, CEP 30161-970 Belo Horizonte, Minas, Brazil d Centro Regional de Ciências Nucleares (CRCN – NE)/ CNEN, Avenida Professor Luiz Freire, no. 200, Cidade Universitária, CEP: 50.740-545 Recife-PE, Brazil e Instituto de Pesquisas Energéticas e Nucleares (IPEN)/CNEN, Caixa Postal 11049, CEP 05422-970 São Paulo, Brazil HIGHLIGHTS  Traceability to the Brazilian metrological chain in nuclear medicine.  Application of the criteria from ISO/IEC17043:2011. article info Article history: Received 24 April 2015 Accepted 20 November 2015 Available online 22 November 2015 abstract Since the inception of its proﬁciency test program to evaluate radionuclide measurement in hospitals and clinics, the National Metrology Laboratory of Ionizing Radiation-LNMRI, that represents Brazilian Na- tional Metrology Institute (NMI) for ionizing radiation has expanded its measurement and calibration capability. Requirements from the National Health Surveillance Agency from Ministry of Health (ANVISA), to producers of radiopharmaceuticals provided an opportunity to improve the full traceability chain to the highest level. Fluorodeoxyglucose (FDG- 18 F) is the only radiopharmaceutical simultaneously produced by all Bra- zilian radiopharmaceutical production centers (RPCs). By running this proﬁciency test, LNMRI began to provide them with the required traceability. Forevaluation, the ratio of RPC to reference value results and ISO/IEC17043:2010 criteria were used. The reference value established as calibration factor on the secondary standard ionization chamber was obtained from three absolute measurements systems, and routinely conﬁrmed in each round of proﬁciency test by CIEMAT/NIST liquid scintillation counting. The γ-emitting impurities were checked using a High-Purity Germanium (HPGe) detector. The results show that Brazilian RPCs are in accordance with (accuracy within 710%) the Brazilian standard for evaluation of measurements with radionuclide calibrators (CNEN NN 3.05., 2013). Never- theless, the RPCs should improve the methodology of uncertainty estimates, essential when using the statistical criteria of ISO/IEC 17043 standard, in addition to improving accuracy to levels consistent with their position in the national traceability chain & 2015 Elsevier Ltd. All rights reserved. Contents lists available at ScienceDirect journal homepage: www.elsevier.com/locate/apradiso Applied Radiation and Isotopes http://dx.doi.org/10.1016/j.apradiso.2015.11.051 0969-8043/& 2015 Elsevier Ltd. All rights reserved. n Corresponding author. E-mail address: aedu@ird.gov.br (A.E. Oliveira). Applied Radiation and Isotopes 109 (2016) 236–241