Standards Organizations Medical Packaging Pros Need to Know

The following associations advocate for the industry, collaborate with other associations, and focus on educating medical device professionals — all with the goal of developing testing methods and guidance documents that unite industry professionals across the supply chain.

Involved standards organizations for medical device packaging are:

The American National Standards Institute (ANSI)

The Association for the Advancement of Medical Instrumentation (AAMI)

ASTM International

European Committee for Standardization, known as CEN (Comité Européen de Normalisation)

GSI

International Medical Device Regulators Forum (IMDRF)

International Safe Transit Association (ISTA)

International Standards Organization (ISO)

National Institute of Standards and Technology (NIST)

National Medical Products Administration (NMPA) [China]

Pharmaceuticals and Medical Devices Agency (PMDA) [Japan]

Sterile Barrier Association

Sterilization Packaging Manufacturers Council (SPMC)

United States Pharmacopoeia (USP)