ISO and IEC standards

Items of ISO and IEC Standards Applicable in Biomedical Engineering

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01

ISO (International organization for standardization)

ISO 7198: Specifies requirements for reusable surgical instruments, covering design, materials, manufacturing and sterilization. ISO 8637: Defines requirements for the design and construction of general purpose syringes used in healthcare. ISO 9001: Establishes the requirements to implement an effective quality management system in any type of organization. Helps improve processes, increase customer satisfaction and achieve continuous improvement. ISO 10651-6: Covers specific requirements for non-invasive electronic blood pressure meters.

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02

ISO (International organization for standardization)

ISO 10993: Describes a comprehensive biological evaluation for materials/devices interacting with biological systems, identifying potential risks. ISO 10993-18: Chemical and toxicological characterization of medical device materials within the risk management process. ISO 11135: Describes the requirements for the sterilization of medical devices using ethylene oxide, a critical process to eliminate acceptable microbial loads. ISO 11139: Standard vocabulary of terms applied to the sterilization processes of medical products, which helps to standardize the communication and understanding of the terms used in the sterilization of medical products, facilitating effective communication between health professionals, manufacturers of medical devices and regulatory bodies.

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03

ISO (International organization for standardization)

ISO 11607: Specifies requirements for the selection of materials, design and use of packaging intended to maintain the sterility of terminally sterilized medical devices. ISO 11608: Focuses on systems for drug administration by injection, defining requirements for their design, manufacturing and functionality. ISO 13485: Specific for medical devices, it complements ISO 9001 with additional requirements focused on safety and risk management throughout the product life cycle. ISO 13408-1: Specific requirements are given for reusable and disposable anesthetic gas supply and waste evacuation systems used in operating rooms.

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04

ISO (International organization for standardization)

ISO 13485:2016: Reinforces aspects such as quality software, validation and management responsibility for the quality management system in medical devices. ISO 14155: Provides requirements for the design, planning and conduct of clinical trials/studies with medical devices, covering ethical aspects, subject protection, reporting, etc. ISO 14155:2020: It is implemented to carry out clinical studies/research with medical devices in humans. ISO 14630: Addresses devices and systems for the administration of intravenous medications and fluids in healthcare settings.

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05

ISO (International organization for standardization)

ISO 14971: Provides a proactive risk management approach for medical devices, identifying hazards, estimating and controlling risks associated with intended use and reasonable misuse.ISO 15223-1: Defines harmonized symbols for marking medical devices. Helps understanding, safety in use, recycling and identification of the product. ISO 17025: Defines criteria for the technical competence of testing/calibration laboratories, essential to guarantee valid and reliable results in medical device testing. ISO 17664: Provides specific guidelines to guarantee the representativeness and precision of the samples collected, as well as for the correct execution of the analytical methods used in the evaluation of the quality and safety of medical devices.

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06

ISO (International organization for standardization)

ISO 18113-1: Establishes the nomenclature and key definitions in the field of in vitro diagnostic (IVD) medical devices. ISO 18562: Establishes requirements to evaluate the biomechanical characteristics of spinal prosthetic implants. ISO 19011: Establishes a guide for auditing management systems in general, applicable to medical devices to verify compliance with ISO 13485 or other standards. ISO 20417: Develops structural elements for a robust medical device information management system in healthcare organizations. ISO 21531: Defines requirements for sampling and analytical techniques applied to medical devices.

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07

ISO (International organization for standardization)

ISO 21649: Categorization and determination of the useful life of disposable surgical implant systems, defining the criteria and processes to classify implant systems into specific categories, taking into account factors such as design, materials used and expected durability. ISO 22442-1: Specifies requirements and guidelines for the application of tissues of animal origin in the manufacture of medical devices. ISO 25424: Define el uso de códigos de identificación únicos en soportes de datos estructurados para el intercambio de información de dispositivos médicos. ISO 27001: Establece las mejores prácticas para un sistema de gestión de seguridad de la información, protegiendo la confidencialidad, integridad y disponibilidad de los datos médicos críticos. ISO 31000: Ofrece principios y directrices genéricas para implementar una gestión eficaz del riesgo en cualquier organización, aplicable también al ámbito de dispositivos médicos.

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09

IEC (International Electrotechnical Commission)

IEC 60601: Establishes safety and performance guidelines for medical equipment, covering aspects such as protection against electrical, mechanical and thermal risks. IEC 60601-1-2: Specifies electromagnetic compatibility requirements for medical electrical equipment, ensuring that these devices do not interfere with other electronic equipment or be susceptible to external interference. IEC 60601-2-33: Specifies the safety requirements for X-ray equipment in medical diagnosis, ensuring the safety of the patient and the operator during the use of these devices. IEC 60601-1-6: establishes general and specific safety and performance requirements for medical electrical equipment related to functional safety and environmental safety.

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10

IEC (International Electrotechnical Commission)

IEC 61508: Establishes the general principles and requirements for the functional safety of electrical, electronic and programmable systems.IEC 62304: Focuses on the development of software for medical devices, ensuring its quality from creation to maintenance. IEC 62304-1: Provides guidelines on the application of risk management according to ISO 14971 to the life cycle of medical device software, ensuring the security of the software in the context of the medical device. IEC 62353: Is responsible for the maintenance of medical equipment, including electrical safety testing and preventive maintenance.

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11

IEC (International Electrotechnical Commission)

IEC 62366: Focuses on making medical devices easy and safe for users to use.IEC 62366-1: Provides specific guidance on the application of usability in medical device product development. IEC 80001: Provides guidelines to ensure that information technology systems in the medical field are secure and effective in operation. IEC 80001-1: Establishes general principles for managing information technology security risks in medical information technology systems, including their interoperability, security and safe use.

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12

IEC (International Electrotechnical Commission)

IEC 80001-2-2: focuses on the application of the risk management principles of ISO 14971 to medical information technology systems, ensuring information security in medical environments.IEC 80601-2-61: Establishes particular safety and performance requirements for blood and biological fluid analyzers, ensuring their safety and accuracy in clinical environments. IEC 60601-2-X: This is a series of particular standards that complement the general IEC 60601-1 standard for different types of electrical medical equipment, such as X-ray equipment, patient monitoring equipment, radiation therapy equipment, among others. IEC 62467: Life cycle management of medical devices.

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13

IEC (International Electrotechnical Commission)

IEC 62570: Risk management requirements for medical devices. IEC 80369: Connection ports for medical devices. IEC 80601-2-X: This is a series of particular standards that complement the general standard. IEC 80601-2-61: For different types of electromedical equipment, such as radiotherapy equipment, lithotripsy equipment, among others. IEC 82304: Life cycle of medical device software - Life cycle processes. IEC 60825: Safety of laser products.

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14

IEC (International Electrotechnical Commission)

IEC 60825: Safety of laser products. IEC 60601-1-3: General requirements for protection against ionizing radiation in medical electrical equipment. IEC 60601-1-8: General requirements, tests and guidance for alarm systems in medical electrical equipment. IEC 60601 -1-10: Requirements for the development of closed physiological regulators. IEC 60601-1-12: Requirements for electromedical equipment and electromedical systems used in the home healthcare environment.

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General synthesis of both regulations

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Exemplification

In a medical device company, it helps standardize processes such as design, manufacturing, packaging, and distribution to ensure quality.

ISO 9001 certification is essential for a medical device company, as it guarantees the standardization, traceability and documentation of key processes such as design, production, packaging and distribution. This allows us to comply with the rigorous quality controls required in this sector, continually improve the management system through audits, and provides peace of mind to authorities and clients by demonstrating strict control throughout the life cycle of the products. ISO 9001 grants reputation and trust for the ability to satisfy patient needs and current regulations, therefore being a fundamental tool that allows a company in this sector to accredit its commitment to safety and quality.

Exemplification

A radiation therapy system manufacturer designed a medical linear accelerator that has two key features to meet this standard:

• A comprehensive real-time dose monitoring and control system that automatically stops the radiation beam if the programmed limit is exceeded, reducing risks.
• Reinforced shielding around the ray tube that meets required attenuation standards to minimize the spread of radiation outside the treatment area.