Effective Date: May 1, 2011
The 27th edition of Standards for Blood Banks and Transfusion Services details the latest standards of practice in blood banking and transfusion medicine. As in the past, a quality management system is the ...
The 27th edition of Standards for Blood Banks and Transfusion Services details the latest standards of practice in blood banking and transfusion medicine. As in the past, a quality management system is the framework of the standards, with each of the 10 chapter headings representing one of the 10 Quality System Essentials.
Significant changes:
Inclusion of the new interim standard requiring the use of FDA approved or FDA deemed equivalent bacterial detection methods.
New requirements that ensure that users follow manufacturers instructions with certain apheresis equipment when said instructions are more stringent than standards.
The standards for the preparation and issue of tissues and derivatives have been separated out from those of blood and components for clarity.
Requirements for new product Cryoprecipitated AHF after thawing have been added to reference standard 5.1.8A, Requirements for Storage, Transport and Expiration
The phrase transfusion transmitted has been replaced with the more inclusive term of transmissible for clarity. The definition in the Glossary of Transmissible Disease has been updated accordingly.

The 27th edition of Standards for Blood Banks and Transfusion Services details the latest standards of practice in blood banking and transfusion medicine. As in the past, a quality management system is the ...
Product Description
Effective Date: May 1, 2011The 27th edition of Standards for Blood Banks and Transfusion Services details the latest standards of practice in blood banking and transfusion medicine. As in the past, a quality management system is the framework of the standards, with each of the 10 chapter headings representing one of the 10 Quality System Essentials.
Significant changes:
Inclusion of the new interim standard requiring the use of FDA approved or FDA deemed equivalent bacterial detection methods.
New requirements that ensure that users follow manufacturers instructions with certain apheresis equipment when said instructions are more stringent than standards.
The standards for the preparation and issue of tissues and derivatives have been separated out from those of blood and components for clarity.
Requirements for new product Cryoprecipitated AHF after thawing have been added to reference standard 5.1.8A, Requirements for Storage, Transport and Expiration
The phrase transfusion transmitted has been replaced with the more inclusive term of transmissible for clarity. The definition in the Glossary of Transmissible Disease has been updated accordingly.
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