Numerous regulatory agencies and standards organizations collaborate to establish the accepted standards for medical equipment. Standard-setting activities include the development of performance characteristics, characterization and testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specifications, labeling, or other technical or policy criteria.

The regulatory agencies and standards organizations integral to establishing the standards and monitoring compliance with those standards include, but are not limited to, particularly the FDA’s Center for Devices and Radiological Health (CDRH), Joint Commission on Accreditation of Health Care Organizations (JC), Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), and the International Organization of Standardization (ISO), International Electrotechnical Commission (IEC), and ASTM International, formally known as the American Society for Testing and Materials (ASTM).

Introduction

The type of device determines the agency (or agencies) to whose regulation it is subject. You will need to do some research to determine which regulatory agency is responsible for your type of device as well as which standards are applicable. Recall from your previous courses in BIOE that medical devices, as defined by the FDA, can range from simple tongue depressors to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general-purpose lab equipment, reagents, and test kits. Also, certain electronic radiation‐emitting products with medical applications and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines, and medical lasers.

Devices criteria

Examples of standards organizations that develop and publish standards for our medical devices.

a non‐governmental organization that prepares and publishes International Standards for all electrical, electronic, and related technologies. Utilizes over 10,000 experts from industry, commerce, government, test and research labs, academia, and consumer groups. When appropriate, IEC cooperates with ISO to ensure that international standards are congruent. requirements for specific products, e.g. MR scanners or Electroencephalograms. For example, IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment. First published in 1977 and regularly updated and restructured, it consists of a general standard, collateral standards, and particular standards.

a globally recognized leader in the development and delivery of international voluntary consensus standards. Utilizes over 30,000 technical professionals and business professionals from over 150 countries to develop standards aimed at promoting public health and safety, supporting the protection and sustainability of the environment, contributing to the reliability of materials, products, systems, and services, and facilitating all levels of commerce. Currently, it provides 12,000 standards that cover a wide range of science and engineering disciplines, including biomedical engineering. ASTM standards encompass virtually all medical devices and services imaginable—and all aspects relevant to medical devices, such as materials and biological components. ASTM standards encompass product areas including anesthesia, biocompatibility, cardiovascular, dental, orthopedics, plastic surgery, and general surgery.

a non-governmental organization that develops and publishes international standards on a wide range of subjects, including medical equipment. For the consumer, ISO International Standards ensure that products and services are safe, reliable, and of good quality. For businesses, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. These standards are very relevant for medical devices and encompass virtually every aspect of device design and implementation, from device inspection requirements to guidelines for medical device labels. For example, ISO 13485 establishes the requirements for a quality management system for both the design and manufacture of medical devices. Covers aspects including risk management, design control during product development, and verification and validation systems.

International Organization for Standardization (ISO)

International Electrotechnical Commission (IEC)

ASTM International