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Standards Give Life Support to Vaccination Evolution


ANSI Sheds Light on Standards that Support National Immunization Awareness Month

In light of national immunization awareness month, the American National Standards Institute (ANSI) pays tribute to its members and standards developing organizations that have helped support healthy lives through standardized medical practices.

National Immunization Awareness Month (NIAM), held each August, helps highlight the importance of vaccinations for people of all ages. Most importantly, the campaign sheds light on why vaccinations prevent seriousand sometimes deadlydiseases.

As ANSI demonstrates through the infographic below, infectious disease prevention included some bizarre practices years agobut thankfully, today, vaccinations are safe and effective thanks in part to the work of the standards community. While not an exhaustive list of standards that support vaccinations, here are a few examples of how standards support various parts of the medical vaccination process. (Continued after infographic)

The American National Standard (ANS) ANSI/AAMI/ISO 13408-2:2018, Aseptic processing of health care products, provides guidance and the requirements on processes, programs, and procedures to develop, validate, and control the manufacturing process of a aseptically processed health care products.

The Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer, published the standard.

Every part of the healthcare process is critical, including the handling of waste materials. The standard CSA Z317.10-2015, published by CSA Group, an ANSI member and standards developer,specifies requirements for the packaging, collection, storage, handling, treatment, and disposal of waste materials within health care and veterinary health care facilities. The standard can apply to both vaccine production facilities and vaccine testing facilities.

The standard also includes guidance for health care waste materials generated outside of traditional health care settings (e.g., health care in the home environment, waste generated or recovered during emergency response activities).

Safe biomanufacturing is another component of safe and effective vaccinations. Another standard, ASTM E3060-16, Standard Guide for Subvisible Particle Measurement in Biopharmaceutical manufacturing using dynamic (flow) imaging microscopy, published by ASTM International, an ANSI member and audited designator, describes best practices and considerations in applying dynamic imaging to identification of potential sources and causes of particles during biomanufacturing.

And ISO 7886-3:2005, Sterile Hypodermic Syringes for Single Use, specifies the properties and performance of sterile single-use hypodermic syringes (with or without needle), made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling.

The International Organization for Standardization (ISO) Technical Committee TC 84, focused on Devices for administration of medicinal products and catheters, developed the standard. ANSI is the U.S. member body to ISO, and AAMI serves as the ANSI-accredited administrator for the U.S. Technical Advisory Group (TAG) to ISO TC 84.

Get promotional and educational materials available from the Centers for Disease Control Prevention (CDC) on the National Immunization Awareness Month website, or access more standards on the ANSI Webstore.


Jana Zabinski

Senior Director, Communications & Public Relations


[email protected]

Beth Goodbaum

Journalist/Communications Specialist


[email protected]