Every two seconds, someone in the U.S. needs blood. On June 14, countries around the world will celebrate World Blood Donor Day, an event that raises awareness of the need for safe blood and blood products, and thanks blood donors for their life-saving gifts.
A large array of standards help enable safe and effective blood donation throughout the process. The proper collection and storage of blood between the time it leaves the human body and enters another ensures safety and low risk of contamination. ISO 6710:2017, Single-Use Containers for Human Venous Blood Specimen Collection, specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers. ISO 6710:2017 was developed by ISO Technical Committee (TC) 76, with U.S. participation. The Technical Advisory Group (TAG) Administrator to ISO/TC 76 is the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer.
Also developed by ISO/TC 76, the ISO 1135 series is a set of five standards under the umbrella of Tranfusion Equipment for Medical Use. All five parts set standards for different parts of transfusion equipment, ensuring compatibility and interchangeability. For example, ISO 1135-3:2016, Transfusion Equipment For Medical Use - Part 3: Blood-Taking Sets For Single Use, specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.
While single-use equipment is a great option for sterile blood collection, many other products must be effectively sterilized for repeated use. ISO/TS 22421:2021, Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities, provides high-level requirements and test methods for sterilization of health care products. This technical specification was developed by ISO/TC 198, Sterilization of health care products, under U.S. leadership, with AAMI serving as the ANSI-delegated Secretariat and as U.S. TAG Administrator. ISO/TC 198 has published more than 60 standards in the scope of health care product sterilization to date.
Those interested in becoming a donor and giving the life-saving gift of blood can contact the American Red Cross or America's Blood Centers to find out if they are eligible and where to donate. First time donors can visit this Red Cross information page that details the process, tips for a successful donation, and the benefits of being a donor.