18.2 Standards for Medical Devices and Instrumentation
4 min read•august 7, 2024
Medical devices and instrumentation require strict standards to ensure safety and effectiveness. This section covers key organizations and standards that govern quality management, electrical safety, materials, sterilization, and software in the medical device industry.
From for quality management to for electrical safety, these standards shape how medical devices are designed, manufactured, and tested. Understanding these regulations is crucial for anyone working in biomedical instrumentation.
Quality Management and Regulatory Standards
International Standards for Quality Management Systems
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ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements
ISO 13485 is an internationally recognized standard that sets out the requirements for a quality management system specific to the medical device industry
Implementing ISO 13485 helps organizations ensure their products and services consistently meet customer and regulatory requirements (FDA, European Medical Device Regulation)
U.S. Standards Organizations for Medical Devices
(American National Standards Institute) is a private, non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States
ANSI accredits standards developers, certification bodies, and technical advisory groups to both the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC)
(Association for the Advancement of Medical Instrumentation) is a nonprofit organization that develops and publishes consensus standards for the medical device industry
AAMI standards cover a wide range of topics, including sterilization, electrical safety, human factors engineering, and (AAMI TIR12:2020 on medical device cleaning)
Electrical Safety and Performance Standards
International Electrotechnical Standards for Medical Devices
IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission (IEC)
IEC 60601 consists of collateral standards (IEC 60601-1-X) that define general requirements and particular standards (IEC 60601-2-X) for specific types of equipment (IEC 60601-2-16 for hemodialysis equipment)
Compliance with IEC 60601 is a requirement for commercialization of electrical medical equipment in many countries
Electromagnetic Compatibility Standards
refers to the ability of electronic equipment to function properly in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment
is a collateral standard that specifies requirements and tests for electromagnetic compatibility of medical electrical equipment
Ensuring EMC is crucial for medical devices to avoid electromagnetic interference that could lead to malfunction or patient harm (interference between a pacemaker and an MRI machine)
Material and Sterilization Standards
Standards for Materials Used in Medical Devices
(formerly known as American Society for Testing and Materials) is an international standards organization that develops and publishes technical standards for a wide range of materials, products, systems, and services
ASTM standards are widely used in the medical device industry to specify requirements for materials, such as implantable metals (ASTM F67 for unalloyed titanium), polymers (ASTM F2026 for silicone elastomers), and ceramics (ASTM F603 for high-purity alumina)
refers to the ability of a material to perform with an appropriate host response in a specific application
is a series of standards that evaluate the biocompatibility of medical devices, covering topics such as cytotoxicity, sensitization, and hemocompatibility testing
Standards for Sterilization of Medical Devices
Sterilization is a critical process for many medical devices to ensure they are free from viable microorganisms before use
specifies requirements for the development, , and routine control of an ethylene oxide sterilization process for medical devices
provides requirements for the development, validation, and routine control of a radiation sterilization process for medical devices (gamma, electron beam, or X-ray radiation)
specifies requirements for the development, validation, and routine control of a moist heat sterilization process for medical devices (steam sterilization)
Software Standards
Standards for Software Validation in Medical Devices
Software validation is the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled
is a standard that specifies life cycle requirements for the development of medical device software and software within medical devices
IEC 62304 requires that software be developed and maintained using a defined software life cycle process, with activities including software development planning, requirements analysis, architectural design, unit implementation and verification, integration and integration testing, and software system testing
FDA guidance on "General Principles of Software Validation" outlines the agency's current thinking on software validation and provides recommendations for software used in medical devices (pre-market submissions, off-the-shelf software)