Specific Medical Device & Equipment Standards

The AAMI standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices. Their website offers the option to submit proposals, join technical committees and send comments on public drafts. Go to the AAMI Report - Priority Issues from the 2012 AMI-FDA Interoperability Summit New!

• AAMI Medical Device Standards New!
• AAMI Index of Published Device and Equipment Standards
• AAMI 2012 White Paper on Medical Device Interoperability New!
• All Standards Publications Available from AAMI New!
• Medical Device Standards Portal – U.S.A. – Collaboration of AAMI, ANSI, ASTM, DIN

ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipment. Their website offers a list of supported standards each with robust in details including the history, significance and use. Visitors can also purchase the material in print or download as a PDF in some cases.

• ASTM - Medical Service and Equipment Standards
• Medical Device and Implant Standards
• Medical Device Standards Portal – U.S.A. – Collaboration of AAMI, ANSI, ASTM, DIN

The Medical Device “Plug-and-Play” (MD PnP) Interoperability Program is accelerating the adoption of medical device interoperability to enable the creation of complete and accurate electronic health records and the cost-effective development of innovative third-party medical “apps” for diagnosis, treatment, research, safety and quality improvements, equipment management, and adverse event detection and reporting when using networked medical devices for clinical care. MD PnP has taken a multi-faceted approach to begin addressing key barriers to achieving interoperability, including the development and support of suitable open standards (e.g. ASTM F2761-09 Integrated Clinical Environment, or ICE), and the elicitation, collection and modeling of clinical use cases and engineering requirements for the ICE platform and “ecosystem.”

Mobile devices that may be regulated as medical devices, and FDASIA Guidelines. This pages includes information of FDA’s Health IT Regulatory Framework and links to Home Health and Consumer Devices, Wireless Medical Devices, Medical Device Data Systems, and Mobile Medical Applications.

• FDA Medical Device Connected Health
• FDA Center for Devices and Radiological Health (CDRH) Data Standards and Terminology Standards
• FDA Medical Device Standards
• U.S. Food and Drug Administration (FDA) Overview of Medical Device Regulation This page offers information on classification of medical device and a simple explanation of what is a medical device under FDA regulation.
• Modifications to the List of Recognized Standards, Recognition List Number: 032 -FDA federal register notice which recognizes voluntary consensus standards to help support and strengthen the interoperability and cybersecurity of networked and connected medical devices.

The IEEE-Standards Association (SA) is a leading consensus building organization that nurtures, develops and advances global technologies. Their website offers a list of standards with descriptions, links to the Working Group, the Oversight Committee and link to the Sponsor. Also included are status updates that note if a standard is in practice or has been withdrawn.

• IEEE Health IT Medical Device Standards
• IEEE 11073-10441 (March 2013) Personal Health Device Communication Part 10441: Device Specialization Cardiovascular Fitness and Activity Monitor ^New!

IHE Product Registry is a searchable database with products supporting IHE Profiles with published IHE Integration Statements. IHE Integration Statements are documents prepared and published by vendors to describe the conformance of their products with the IHE Technical Framework. The tool includes many options for filtering including System Name, System Type and Actor.

• IHE Product Registry
• IHE Patient Care Device Standards
• IHE & Continua Collaborate on Medical Device Standards

ISO 13485 Certification for Medical Device Manufacturers

• CEN ISO/IEEE 11073 Health Informatics - Medical / health device communication standards enable communication between medical, health care and wellness devices and with external computer systems. ^New!
• Open Systems Interconnection (OSI) model (ISO/IEC 7498-1) is a conceptual model that characterizes and standardizes the internal functions of a telecommunication system by partitioning it into abstraction layers. The model is a product of the Open Systems Interconnection project at the International Organization for Standardization (ISO). ^New!

Go back to main Medical Devices and Equipment Standards Page to read more about NIST activities.

• NIST Medical Device Interoperability Research
• NIST Medical Device Communication, Standards Development, and Testing