January is National Blood Donor Month, an annual celebration in recognition of the individuals whose blood donations provide lifesaving support to millions of people in need, including accident victims, hemophiliacs, and recent surgery patients. As blood donation campaigns ramp up, voluntary consensus standards play an important role in the safe and effective collection, storage, and transfusion of donated blood.
Before giving blood, potential donors are given a series of short tests to ensure their eligibility, including a blood pressure screening; individuals with blood pressure that is too low or high may be asked to hold off on donating. ANSI/AAMI/ISO 81060-1:2007, Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, lays out specifications for the use of inflatable blood pressure measurement cuffs, such as those used in many blood donation centers. The standard was developed by the International Organization for Standardization (ISO) Technical Committee (TC) 121, Anaesthetic and respiratory equipment, Subcommittee (SC) 3, Lung ventilators and related equipment. The American National Standards Institute (ANSI) holds the secretariat to both TC 121 and SC 3; ANSI has delegated the secretariat of SC 3 to Dave Osborn of Philips Medical Systems. ASTM International, an ANSI member and audited designator, serves as the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator for both TC 121 and SC 3. ANSI/AAMI/ISO 81060-1:2007 has been adopted as an American National Standard (ANS) by the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer.
Standards also help transfusions take place in a safe, responsible manner. A standard developed by AAMI, ANSI/AAMI BF64:2002 (R2011), Leukocyte Reduction Filters, provides guidelines for a process to treat blood during a transfusion, including labeling requirements, test methods, and terminology for disposable filters used to reduce the leukocytes, or white blood cells, from blood or blood components during a transfusion. Leukocytes can trigger serious reactions during transfusions for pregnant patients, newborn children, cardiovascular surgery patients, and others.
Standards even play a part in one of the non-medical aspects of blood donation: the cookies and other baked goods that many blood donation centers give out following a donation. An international standard, IEC 60335-2-39 Ed. 6.0 b:2012, Household and similar electrical appliances - Safety - Part 2-39: Particular requirements for commercial electric multi-purpose cooking pans, establishes safety guidelines for pans used in commercial bakeries, among other locations. The standard was developed by International Electrotechnical Commission (IEC) TC 61, Safety of household and similar electrical appliances, SC 61E, Safety of electrical commercial catering equipment. Underwriters Laboratories (UL), an ANSI member and audited designator, serves as the U.S. National Committee (USNC)-approved U.S. TAG Administrator to TC 61.