Medical Device Standards

Guidance, requirements, and specifications for medical devices

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. These standards serve as benchmarks for designing, developing, manufacturing, and evaluating medical devices and help ensure they are safe, effective, and reliable.

Standards are important in the medical device industry as they provide a common framework for manufacturers, regulators, healthcare professionals, and other stakeholders.

International standard organisations

Organisations that provide and maintain international standards relevant to medical devices include:

International standard harmonisation

Standards help ensure consistency and interoperability among devices, enable international trade by harmonising requirements across different regions and facilitate regulation compliance.

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.

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.

Product standards specify the requirements for the end product. 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. These standards are widely recognised and utilised in the medical device industry to ensure compliance with regulatory requirements, enhance product quality, and manage risks associated with medical device manufacturing, testing, and usage.

Common standards for medical devices include:

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:

Electrical Safety:

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 characterization of a sterilizing agent and the development, validation, and routine control of a sterilization 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 sterilization 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 sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation, and routine control of a sterilization process for medical devices

Standards for healthcare organisations

  • ISO/CD TS 5137 - Medical device maintenance management for healthcare delivery organizations
  • ISO 7101:2023 - Healthcare organization management — Management systems for quality in healthcare organizations — Requirements
  • ISO 15189:2022 - Medical laboratories — Requirements for quality and competence
  • ISO 14000 family - Environmental management
  • ISO 50001 - Energy management

Resources

    MedDev Central Academy:

    MedDev Central Knowledge Hub:

    European Union (EU):

    Medical Devices Regulation (MDR) 2017/745:

    In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746

    Biocompatibility: The ability of a material to perform with an appropriate host response when applied as intended.

    Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.

    Clinical Investigation: Any systematic investigation or study in or on one or more human subjects undertaken to assess the safety or performance of a medical device.

    Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.

    Harmonisation: The process of aligning standards, requirements, and procedures across different jurisdictions to ensure consistent safety and efficacy evaluations and market access for medical devices.

    Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.

    International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).

    Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)

    Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.

    Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.

    Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.

    Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.

    Sterilisation: A process designed to destroy all microbial life, including spores, on a medical device.

    Updated on 29 May 2024