Standards available through USF

ASTM Compass This link opens in a new window
Review the ASTM standards USF has access to through their Compass platform. Only select standards available.
IEEE Xplore [Off-campus access also via USF VPN] This link opens in a new window
Access IEEE's standards through their database platform. All standards are available.

ISO Standards
Leverage the ISO standards - a collection of guidelines, specifications, and requirements designed to ensure quality, safety, efficiency, and interoperability across a wide range of products, services, and systems globally.

Standards available outside of USF

CPSC Standards
Offers an easy-to-use database of regulated products, including tools to identify mandatory and voluntary standards.
DoD Standards
The official source for DoD standardization documents, housing requirements documents cited in defense acquisitions.
DoE Standards
Provides a searchable database of approved and draft technical standards relevant to the DoE.
EPA Standards
Maintains a webpage dedicated to the use and participation in Voluntary Consensus Standards and other private sector standards.
FDA Standards
Food and Drug Adminstration (FDA) standards and regulations can be accessed for free on the FDA website. These are guidelines and regulations pertaining to food and drug safety in the United States.
NASA Technical Standards
Publishes technical standards critical for NASA missions, defining engineering, safety, mission assurance, and health and medical requirements.
NIST Standards
A comprehensive database containing various standards referenced in the U.S. Code of Federal Regulations.
OSHA Standards
Standards set forth by OSHA are publicly accessible and free. They can be found on the OSHA website. They focus on safety guidelines and regulations for workplaces in the United States.

Contact your USF Health Librarian

Stephanie Tomlinson

Email Me

Subjects: Athletic Training, Health & Medicine, Medicine, Physical Therapy, Physician Assistant

Engineering

Biomedical Device Regulation

Biomedical standards and device regulations are foundational to healthcare innovation, ensuring that medical devices brought to market are safe, effective, and of high quality. This framework protects patient health and supports the development of new medical technologies, ensuring they meet rigorous standards before being used in clinical settings.

Definition and Importance

Biomedical standards are essential for the lifecycle of medical devices, from design and manufacturing to use. They ensure devices perform reliably and are safe, fostering trust among users, healthcare providers, and regulatory bodies. Standards cover various aspects, including material safety, device functionality, and interoperability.

Key Standards Organizations

International Organization for Standardization (ISO) sets global standards for quality management and device safety, such as ISO 13485 for medical devices. Visit ISO.
American National Standards Institute (ANSI) leads efforts in the U.S. to develop voluntary consensus standards for a wide range of products, including medical devices. More information at ANSI.
International Electrotechnical Commission (IEC) focuses on electronic and electrical technologies, offering critical standards like IEC 60601 for the safety of medical electrical equipment. Details at IEC.

Regulatory Bodies

U.S. Food and Drug Administration (FDA) oversees the regulation of medical devices in the U.S., ensuring they meet necessary safety and efficacy standards before they can be marketed. Explore FDA.
European Medicines Agency (EMA) manages device regulation within the EU, implementing comprehensive directives and regulations to maintain device safety and performance across member states. Visit EMA.

Biomedical Device Review and Classification

Device regulation encompasses the entire process that medical devices must undergo to be approved for market entry. This ensures they meet the highest standards of safety and effectiveness, protecting end-users and patients from potential harm.

FDA's Regulatory Framework for Medical Devices

The FDA uses a classification system to determine the level of control required for medical devices, ranging from Class I (lowest risk) to Class III (highest risk). The regulatory pathway for a device, including establishment registration, device listing, premarket notification or approval, and adherence to Quality System Regulation, depends on its classification. The integration of ISO 13485:2016 into the FDA's regulatory practices highlights a commitment to international standards. For more, see FDA's Device Regulation Overview.

Compliance and Approval Process

The compliance and approval process includes rigorous testing and review, ensuring devices are safe and effective for their intended use. This may involve premarket approval (PMA), 510(k) clearance, or obtaining a CE mark in Europe, each pathway tailored to the device's classification and intended use.

Post-Market Surveillance

Post-market surveillance is critical for monitoring the performance of medical devices once they are in use, ensuring they continue to meet safety and effectiveness criteria. This process can identify potential issues early, ensuring ongoing protection for patients and users.