In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme-Reference-Cited by-同舟云学术

In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme

Published:2020-09-28 Issue:1 Volume:116 Page:3-12
ISSN:0042-9007
Container-title:Vox Sanguinis
language:en
Short-container-title:Vox Sang

Author:

Mbunkah Herbert Afegenwi¹,Reinhardt Jens²,Kafere Chancelar¹,Scheiblauer Heiner³^ORCID,Prat Irena⁴,Nübling Claudius Micha¹^ORCID

Affiliation:

1. International Coordination, Regulatory Service Paul‐Ehrlich‐Institut Langen Germany

2. Haematology/Transfusion Medicine Paul‐Ehrlich‐Institut Langen Germany

3. IVD Testing LaboratoryPaul‐Ehrlich‐Institut Langen Germany

4. Regulation of Medicines and other Health Technologies Prequalification Team – Diagnostics World Health Organization Geneva Switzerland

Publisher

Wiley

Subject

Hematology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/vox.12996

Reference20 articles.

1. Global Harmonization Task Force:Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ 2012.http://www.imdrf.org/docs/ghtf/final/sg1/technical‐docs/ghtf‐sg1‐n071‐2012‐definition‐of‐terms‐120516.pdf. [Last Accessed 30 June 2020]

2. Sufficient blood, safe blood: can we have both?

3. World Health Organization:Screening donated blood for transfusion‐transmissible infections 2010.https://www.who.int/bloodsafety/ScreeningTTI.pdf. [Last Accessed 30 June 2020]

4. Multiple HBV transfusion transmissions from undetected occult infections: revising the minimal infectious dose

5. European Commission:Factsheet for Manufacturers of in vitro Diagnostic Medical Devices 2018.https://ec.europa.eu/growth/sectors/medical‐devices_en. [Last Accessed 30 June 2020]

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