International Society for Blood Transfusion Guidelines for Traceability of Medical Products of Human Origin-Reference-Cited by-同舟云学术

International Society for Blood Transfusion Guidelines for Traceability of Medical Products of Human Origin

Published:2023-05-25 Issue:7 Volume:118 Page:587-597
ISSN:0042-9007
Container-title:Vox Sanguinis
language:en
Short-container-title:Vox Sanguinis

Author:

Ashford Paul¹,Butch Suzanne²^ORCID,Barhoush Amjad Omar³,Bolton Wayne⁴,Cusmai Michele⁵,Espensen Lone⁶,Geary Josh⁷,Moniz Karen⁸

Affiliation:

1. Roper Management Consultants Ltd Kent UK

2. Department of Pathology Michigan Medicine Ann Arbor Michigan USA

3. Omar Freelance Quality and Accreditation Consultant Rochester Minnesota USA

4. Australian Red Cross Lifeblood, Information, and Communications Technology Adelaide South Australia Australia

5. Swiss SCWeb AG Lugano Switzerland

6. Department of Clinical Immunology Odense University Hospital Odense Denmark

7. Cell Manipulation Core Facility Dana‐Farber Cancer Institute Boston Massachusetts USA

8. ICCBBA San Bernardino California USA

Publisher

Wiley

Subject

Hematology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/vox.13473

Reference8 articles.

1. 21 CFR Part 606 Current Good Manufacturing Practices for Blood and Blood Products.Department of Health and Human Services—Food and Drug Administration.2022.https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606. Accessed 16 Jan 2023.

2. EU: EC Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection testing processing storage and distribution of human blood and blood components and amending Directive 2001/83/EC.

3. Transmission of Hepatitis C Virus to Several Organ and Tissue Recipients from an Antibody-Negative Donor

4. ISO 1497:2019.Medical devices. Application of risk management to medical devices. International Organisation for Standardization.

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