ANSI - American National Standards Institute
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Standards Support Safety as Universal Flu Vaccine Development Progresses

New York, Jul 20, 2010

New research conducted by scientists at the National Institutes of Health (NIH) has brought the possibility of a universal flu vaccine closer to reality. This type of vaccine would potentially provide protection from all flu strains for decades. As the science for a universal flu vaccine advances, standards are in place to promote safety for all vaccines.

Following a thorough hand washing, many doctors and nurses pull on rubber gloves before administering a vaccine to prevent the spread of germs – especially during flu season. A standard developed by ASTM International, a member and audited designator of the American National Standards Institute (ANSI), guides these disposable medical supplies. ASTM D3578-05e1, Standard Specification for Rubber Examination Gloves, covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.

A number of International Standards developed by the International Organization for Standardization (ISO) address the safe and effective use of hypodermic needles and syringes like the ones used in flu vaccines. ISO 7864:1993, Sterile hypodermic needles for single use, specifies a number of requirements for needles, including nomenclature for components, cleanliness, limits for acidity and alkalinity, size designation, performance, packaging, labeling, storage container, and transport wrapping.

Another ISO standard guides hypodermic syringes for single use in several parts:

  • ISO 7886-1:1993, Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use

  • ISO 7886-2:1996, Part 2: Syringes for use with power-driven syringe pumps

  • ISO 7886-3:2005, Part 3: Auto-disable syringes for fixed-dose immunization

  • ISO 7886-4:2006, Part 4: Syringes with re-use prevention feature

These standards were developed by ISO Technical Committee (TC) 84, Devices for administration of medicinal products and intravascular catheters, Subcommittee (SC) 1, Syringes, needles, and intravascular catheters for single use. The ANSI-accredited U.S. Technical Advisory Group (TAG) administrator for this SC is the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI organizational member and accredited standards developer.

For more information on the development of a universal flu vaccine, see the NIH news release.

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