Detalhe da pesquisa
1.
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.
Clin Chem Lab Med
; 61(4): 608-626, 2023 03 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-36716120
2.
Implementation of the new EU IVD regulation - urgent initiatives are needed to avert impending crisis.
Clin Chem Lab Med
; 2021 Sep 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-34533005
3.
Recommendation for the review of biological reference intervals in medical laboratories.
Clin Chem Lab Med
; 54(12): 1893-1900, 2016 Dec 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-27748267
4.
Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO).
Clin Chem Lab Med
; 53(8): 1173-80, 2015 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-26055950
5.
Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories.
Clin Chem Lab Med
; 55(3): 470, 2017 03 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-28161692