After a potential donor arrives at a blood donation center, they normally undergo a series of brief tests to make sure that they are eligible to donate blood. One of these tests is usually a blood pressure screening; individuals with blood pressure that is too low or high are often asked to hold off on donating. A standard developed by the International Electrotechnical Commission (IEC) provides important guidance in connection with blood pressure measurement. IEC 80601-2-30 Ed. 1.1 b:2013, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, covers safety and performance for a method of measuring blood pressure that does not require puncturing an artery. The standard, which was developed by IEC Technical Committee (TC) 62, Electrical equipment in medical practice, Subcommittee (SC) 62D, Electromedical equipment, applies to automated, electrically powered sphygmomanometers used by medical professionals and in the home healthcare environment. IEC TC 62 is chaired by Dr. Rodolfo Godinez of the United States and ANSI member the Advanced Medical Technology Association (AdvaMed) serves as the United States National Committee (USNC)-approved Technical Advisory Group (TAG) Administrator for IEC TC 62. The USNC has delegated secretariat duties for SC 62D to the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer; AAMI also serves as the USNC-approved U.S. Technical Advisory Group (TAG) Administrator to SC 62D.
Once an individual has been cleared to give blood, the actual work involved in extracting and preserving the needed blood begins. To support this work, an International Standard from the International Organization for Standardization (ISO) sets down requirements for single-use blood transfusion sets and provides guidance on quality and performance specifications for materials used in transfusion sets, among other information. ISO 1135-4:2012, Transfusion equipment for medical use - Part 4: Transfusion sets for single use, was developed by ISO TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use; AAMI serves as the ANSI-accredited U.S. TAG to ISO TC 76.
ANSI/AAMI BF64:2012, Leukocyte Reduction Filters, a standard from AAMI, helps to support efforts to keep transfusions safe. Leukocytes, also known as white blood cells, have the potential to trigger adverse reactions during transfusions for newborns, pregnant patients, and others. The standard sets down guidelines for treating blood during a transfusion and includes terminology for disposable filters used to reduce the leukocytes.