Recommendation for the design of stability studies on clinical specimens-Reference-Cited by-同舟云学术

Recommendation for the design of stability studies on clinical specimens

Published:2023 Issue:3 Volume:12 Page:61
ISSN:2305-2198
Container-title:Laboratornaya sluzhba
language:en
Short-container-title:Lab. sluzh.

Author:

Gomez-Rioja R.,Von Meyer A.,Cornes M.,Costelloe S.,Vermeersch P.,Simundic A-M.,Nybo M.,Baird G.S.,Kristensen G.B.,Cadamuro J.

Publisher

Media Sphere Publishing Group

Subject

General Medicine

Reference48 articles.

1. ISO 15189. Medical laboratories — requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization; 2012

2. ISO15189.Medicallaboratories—requirementsforqualityand competence. Geneva, Switzerland: International Organization for Standardization; 2022

3. Directive98/79/E.C.oftheEuropeanParliamentandoftheCouncilof 27 october 1998 on in vitro diagnostic medical devices; 1998. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/? uri=CELEX:31998L0079&from=EN

4. Regulation (E.U.) 2017/746 of the European Parliament and of the Council of 5 april 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/E.C. and Commission Decision 2010/227/E.U; 2017. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0746-20220128&from=EN

5. Cadamuro J, Bergsten P, Mörwald K, Weghuber D, Jabbour J, Brunner SM, et al. Deviating glucose results in an international dual- center study. A root cause investigation. Biochem Med. 2022;32:011001

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