Medical Device Standards

What are medical device standards?

A medical device standard is a document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.

Standards are one of the regulations that ensure medical devices are safe, effective, and high-quality.

Standards define the “state-of-the-art.” They are considered the current best practices for developing, manufacturing, and managing medical devices in the medical device world. They are benchmarks for designing, developing, manufacturing, and evaluating medical devices. Standards provide a common framework for manufacturers, regulators, healthcare professionals, and other stakeholders.

International standard organisations

A colleague once described standards as the “guidance developed by gurus.” It is true that standards are developed collaboratively by teams of experts who collectively have decades of experience. Organisations that provide and maintain international standards relevant to medical devices include:

• International Organization for Standardization (ISO) provide and maintain standards across a wide range of sectors
• International Electrotechnical Commission (IEC) develops international standards for electrical and electronic technologies, including medical electrical equipment and medical software.
• International Commission on Non-Ionizing Radiation Protection (ICNIRP) provides guidelines and recommendations on the protection against non-ionizing radiation, which can be relevant to certain medical devices.
• Clinical and Laboratory Standards Institute (CLSI) develops standards for clinical and laboratory testing that can be applied to medical devices used in diagnostics.
• Global Medical Technology Alliance (GMTA) represents the medical technology industry and works on global regulatory and policy issues related to medical devices.
• International Medical Device Regulators Forum (IMDRF) is a global forum that works on harmonising and standardising medical device regulations across different jurisdictions.
• International Accreditation Forum (IAF) focuses on the accreditation of conformity assessment bodies, which play a role in ensuring the quality and safety of medical devices.

These organisations are responsible for maintaining and updating standards as they develop in the context of other technology and market changes.

One point of discord in the medical device community is the cost of standards. While regulations are free to access, standards are not. They are subject to copyright law and are only available for purchase under a license. Since multiple standards are usually required for each medical device, the cumulative cost of standards can be high, especially for licensees in low and middle-income countries (LMICs).

International standard harmonisation

Standards help ensure device consistency and interoperability, enabling international trade by harmonising requirements across different regions.

A standard has been harmonised when adopted or recognised by a regulatory authority. In these cases, evidence of conformity with a standard can be used as evidence of conformity with local regulations. As such, regulatory authorities often require compliance with standards, and each regulatory authority maintains a list of harmonised standards.

As discussed in the sections above, international standards organisations update standards when circumstances change. After a standard update, each regulatory authority takes time to review the changes and ensure that the standard is still harmonised with their local regulations. In these instances, it can be challenging to determine which version of the standard should be followed. It’s essential to get expert regulatory guidance in these cases.

Types of standards

There are many different standards relevant to medical devices, which can be separated into two main types: product and process standards. Both are essential components of medical device regulation, but they focus on different aspects of the manufacturing and quality assurance processes:

• Product Standards: define the specific requirements and characteristics a medical device must meet to ensure its safety, efficacy, and performance related to design, materials, construction, labelling, sterilisation, and performance testing. These standards are not available for all medical devices.
• Process Standards: focus on the methods, procedures, and controls employed during the design and development, manufacturing, and quality assurance processes. These standards aim to ensure consistency, reliability, and quality throughout the production lifecycle of medical devices. In essence, while product standards specify the requirements for the end product itself, process standards outline the procedures and practices necessary to consistently manufacture, test, and maintain the quality of medical devices.

Important medical device standards

There are thought to be approximately 4000 international standards relevant to medical devices. MedDev Central has compiled a list of standards widely recognised and utilised in the medical device industry.

Quality Management:

• ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 9001:2015: Quality management systems �" Requirements

Risk Management:

• ISO 14971:2019: Medical devices - Application of risk management to medical devices

Usability Engineering:

• IEC 62366:2015: Medical devices - Part 1: Application of usability engineering to medical devices

Clinical Investigations:

• ISO 14155:2020: Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 20916:2019 - In vitro diagnostic medical devices �" Clinical performance studies using specimens from human subjects �" Good study practice

Labelling:

• ISO 15223-1:2021: Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
• ISO 18113: 2022 Series - In vitro diagnostic medical devices �" Information supplied by the manufacturer (labelling)

Software and IT standards:

• IEC 62304:2006: Medical device software - Software life cycle processes
• ISO 27001:2022: Information security management systems

Electrical Safety:

• IEC 60601:2020 series: Medical electrical equipment The IEC 60601 series is divided into multiple parts, each addressing specific types of medical electrical equipment or safety and performance aspects.

Biocompatibility:

• ISO 10993-1:2018: Biological evaluation of medical devices The ISO 10993 series provides a comprehensive framework for evaluating the biocompatibility of medical devices. It includes various parts, each addressing different aspects of biocompatibility testing.
• ISO 18562 Series of standards addresses the biocompatibility of medical devices that come into contact with breathing gases.

Sterilisation:

• ISO 14937:2009 - Sterilization of health care products �" General requirements for characterisation of a sterilising agent and the development, validation, and routine control of a sterilisation process for medical devices
• ISO 11607: Packaging for terminally sterilized medical devices
• ISO 11135:2014 - Sterilization of health care products �" Ethylene oxide �" Requirements for the development, validation, and routine control of a sterilisation process for medical devices
• ISO 11137 Series - Sterilization of health care products �" Radiation
• ISO 17665 Series - Sterilization of health care products �" Moist heat
• ISO 14160:2011 - Sterilization of health care products �" Liquid chemical sterilising agents for single-use medical devices utilising animal tissues and their derivatives �" Requirements for characterisation, development, validation, and routine control of a sterilisation process for medical devices

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