Trends in ISO and IEC standards
As of August 2024
１．ISO and IEC standards in regulation
・IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.
・Harmonized Regulatory Frameworks like IMDRF activities, along with Recognized International Standards such as ISO and IEC, can serve as possible foundation to support for reliance.
・The following presentation material summarizes the ISO and IEC standards in regulation based on IMDRF standards activities.
２．Major Published Standards that PMDA was involved in developing
2.1 Horizontal standards for medical devices
Risk management (ISO 14971 SERIES)・ISO 14971 Ed.3 （published December 2019)
「Medical devices - Application of risk management to medical devices」
「Medical devices - Application of risk management to medical devices」
＜Overview＞ISO 14971 Ed.3 is the standard for risk management of medical devices that was revised to harmonize with ISO/IEC Guide 63: 2009 - Guide for safety aspects of medical devices, as well as to adapt to new technical fields such as security and changes in the environment in which medical devices are used.
・ISO/TR 24971 Ed.2 （published June 2020)
「Medical devices - Guidance on the application of ISO 14971」
「Medical devices - Guidance on the application of ISO 14971」
＜Overview＞ISO/TR 24971 Ed.2 is the guidance document for ISO 14971 Ed.3, which contains examples and applications from the annexes of ISO 14971 Ed.2 and adds annexes for new technological fields such as security.
Electrical safety (IEC 60601 SERIES)・IEC 60601-1 Ed.4 Architecture Document （published May 2020)
「ARCHITECTURAL SPECIFICATION FOR SAFETY STANDARDS OF MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS, AND SOFTWARE USED IN HEALTHCARE」
「ARCHITECTURAL SPECIFICATION FOR SAFETY STANDARDS OF MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS, AND SOFTWARE USED IN HEALTHCARE」
＜Overview＞The IEC 60601-1 Ed.4 architectural specification is a document available on the IEC website, which establishes an architectural concept for IEC 60601 Ed.4 which to be published in 2024. In this document, eight goals are set up and the guidelines are showed for each goal.
・IEC 60601-1 Ed.4 Design Specification （published December 2023)
「Design Specification Outline for the fourth edition of IEC 60601-1」
「Design Specification Outline for the fourth edition of IEC 60601-1」
＜Overview＞IEC 60601-1 Ed.4 Design Specification supplements the Architectural Specification and provides clear, concise basis for developing the next edition of IEC 60601-1. The content and specific requirements are grouped into general requirements and a set of clusters according to kind or source of harm/hazardous situation
Biological Safety (ISO 10993 SERIES)・ISO 10993-1 Ed.5 （published August 2018)
「Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process」
「Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process」
＜Overview＞ISO 10993-1 Ed.5 provides the basic principles that are important for evaluating the biological safety of medical devices in non-clinical test. The revision indicates that biological safety should be evaluated within a risk management process.
・ISO 10993-10 Ed.4 （published November 2021)
「Biological evaluation of medical devices - Tests for skin sensitization」
「Biological evaluation of medical devices - Tests for skin sensitization」
＜Overview＞ISO 10993-10 Ed.4 is a specification for skin sensitization testing of biological safety. It includes the exaggerated extraction method using organic solvents proposed by Japan. In the process of the revision from Ed.3 to Ed.4, the description of the irritation test was transferred from ISO 10993-10 to ISO 10993-23.
・ISO 10993-18 Ed.2 （published January 2020)
「Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process」
「Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process」
＜Overview＞ISO 10993-18 Ed.2 provides the concept of evaluation of biological safety by chemical characterization. In addition to introducing specific analysis methods, this revision presents the concept of risk assessment.
・ISO 10993-23 Ed.1 （published January 2021)
「Biological evaluation of medical devices - Tests for irritation」
「Biological evaluation of medical devices - Tests for irritation」
＜Overview＞ISO 10993-23 Ed.1 is a specification for irritation testing of biological safety. It includes in vitro irritation tests using three-dimensional skin models. ISO 10993-23 Ed.1 was prepared by separating sections on irritation testing from ISO 10993-10 Ed.3.
Clinical Evaluation・ISO 14155 Ed.3 （published July 2020)
「Clinical investigation of medical devices for human subjects - Good clinical practice」
「Clinical investigation of medical devices for human subjects - Good clinical practice」
＜Overview＞ISO 14155 Ed.3 addresses Good Clinical Practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical device.
Cybersecurity・IEC 81001-5-1 Ed.1 （published December 2021)
「Health software and health IT systems safety, effectiveness and security -Part 5-1: Security - Activities in the product life cycle」
「Health software and health IT systems safety, effectiveness and security -Part 5-1: Security - Activities in the product life cycle」
＜Overview＞IEC 81001-5-1 Ed.1 is a process standard for healthcare software, including software embedded in medical devices, that specifies activities that manufacturers perform as part of their development and maintenance life cycle.
2.2 Individual standards for medical devices
Robotics・IEC 80601-2-77 Ed.1 （published July 2019)
「Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment」
「Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment」
＜Overview＞IEC 80601-2-77 Ed.1 is a particulars standard in the IEC 60601 SERIES for surgical robots. It covers robotically assisted surgical equipment for a wide range of applications such as endoscopic surgery and orthopedic surgery.
・IEC 80601-2-78 Ed.1 （published July 2019)
「Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation」
「Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation」
＜Overview＞IEC 80601-2-78 Ed.1 is a particular standard in the IEC 60601 SERIES for medical robots for rehabilitation of patient’s movement functions and so on. Japan is the convenor of the Joint Working Group developing this standard.
Dentistry・ISO 13017 Ed.2 （published July 2020)
「Dentistry - Magnetic attachments」
「Dentistry - Magnetic attachments」
＜Overview＞ISO 13017 Ed.2 is a standard for dental magnetic attachments. This revision is a Japanese proposal and reflects JIS, which reflects the contents of ISO 13017 Ed.1 that need to be revised first. During the development process of the standard, support was provided as part of the PMDA's Academia Dispatch Program.
・ISO 10873 Ed.2 （published July 2021)
「Dentistry−Denture adhesives」
「Dentistry−Denture adhesives」
＜Overview＞ISO 10873 Ed.2 is a standard for dental denture adhesives. This revision is a Japanese proposal and reflects JIS, which reflects the contents of ISO 10873 Ed.1 that need to be revised first. During the development process of the standard, support was provided as part of the PMDA's Academia Dispatch Program.
・ISO 23401-1 Ed.1 （published January 2023)
「Dentistry - Chairside denture base relining materials - Part 1: Hard type materials」
「Dentistry - Chairside denture base relining materials - Part 1: Hard type materials」
＜Overview＞ISO 23401-1 Ed.1 is a standard for dental chairside denture base relining materials. This revision is a Japanese proposal. During the development process of the standard, support was provided as part of the PMDA's Academia Dispatch Program.
Implants for surgery・ISO 13019 Ed.1 （published June 2018)
「Tissue-engineered medical products - Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis」
「Tissue-engineered medical products - Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis」
＜Overview＞ISO 13019 Ed.1 is a standard for quantification of sulfated glycosaminoglycans for evaluation of chondrogenesis. This revision is a Japanese proposal. During the development process of the standard, support was provided as part of the PMDA's Academia Dispatch Program.
3. Major standards under development involving PMDA
・ISO/TS 24971-2 （Revision）
「Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence」
「Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence」
・IEC 60601-1 Ed.4 （Revision）
「Medical electrical equipment - Part 1: General requirements for basic safety and essential performance」
「Medical electrical equipment - Part 1: General requirements for basic safety and essential performance」
・IEC 60050-880 （New）
「INTERNATIONAL ELECTROTECHNICAL VOCABULARY - Part 880: Electrical equipment, electrical systems and software used in healthcare」
「INTERNATIONAL ELECTROTECHNICAL VOCABULARY - Part 880: Electrical equipment, electrical systems and software used in healthcare」
・ISO 10993-1 Ed.6 （Revision）
「Biological evaluation of medical devices Part 1:Requirements and general principles for the evaluation of biological safety within a risk management process」
「Biological evaluation of medical devices Part 1:Requirements and general principles for the evaluation of biological safety within a risk management process」
・ISO 14155 Ed.4 （Revision）
「Clinical investigation of medical devices for human subjects Good clinical practice」
「Clinical investigation of medical devices for human subjects Good clinical practice」
・ISO 18969 Ed.1 （New）
「Clinical evaluation of medical devices」
「Clinical evaluation of medical devices」