[Essential for Medical Device Manufacturers!] Bilingual Edition of International Standard for Biological Safety Evaluation of Medical Devices, 'ISO 10993-1:2025', Now Available
The Japanese Standards Association announced on April 15, 2026, the release of the Japanese-English bilingual edition of the international standard for biological safety evaluation of medical devices, 'ISO 10993-1:2025'. This standard is crucial for proving human safety of medical devices and helps manufacturers with global regulatory compliance and efficient risk management.
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The Japanese Standards Association (Headquarters: Minato-ku, Tokyo; President: Hiroshi Asahi) announced on Wednesday, April 15, 2026, the release of the Japanese translation of the standard for biological evaluation of medical devices, 'ISO 10993-1:2025'.
■ What is 'ISO 10993-1'?
To introduce medical devices to the market, biological evaluation to prove safety for the human body is indispensable. At its core is 'ISO 10993-1'. ISO 10993-1 defines principles and requirements for evaluating the biological safety of devices within the broader risk management framework established by ISO 14971. It also provides guidelines to manufacturers and evaluators on the process of identifying, assessing, and managing biological risks related to materials, design choices, and tissue contact during the 'intended use' of the device.
■ Main Benefits of ISO 10993-1:2025
* Ensures patient and user safety through systematic biological risk assessment.
* Supports global regulatory compliance and market approval.
* Streamlines testing strategies and promotes the reduction of animal testing.
* Facilitates early detection and control of potential biological hazards during the design and development phases.
* Aligns biological evaluation with the ISO 14971 risk management process.
ISO 10993-1:2025: Biological evaluation of medical devices – Part 1: Requirements and general principles for evaluation of biological safety within a risk management process.
■ Main Changes in This Revision
* Overall structure completely revamped to further enhance alignment with ISO 14971.
* New guidance added regarding contact duration, material characterization, and identification of biological hazards.
* Terminology updated for greater clarity.
Purchase and details here.
Related Standards
ISO 10993-17:2023/Amd 1:2025 Amendment 1 – Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device components.
Main Changes in Amd 1:2025 (Amendment 1)
Amendment 1, issued in 2025, aims at technical fine-tuning and clarification of descriptions found after the operation started for the 2023 edition.
* Consistency of formulas: Corrected inconsistencies in calculation formulas and units when calculating toxicological risk (Margin of Safety: MOS).
* Refinement of terminology definitions: Adjusted wording to ensure consistency with other ISO 10993 series for specific terms used in the evaluation process.
* Supplement to Annexes: Specifies guidance for creating risk assessment reports.
Purchase and details here.
— What is an Amd (Amendment)? —
An Amd is issued when it is determined that new material needs to be added to an existing standard, or when editorial or technical corrections are made.
*Prices for standards may change. Please understand.
ISO Management System Special Page
JSA Library Server Service Details
(Department in charge: Customer Service Department, Sales Service Team; E-MAIL: csd@jsa.or.jp)
● About the Japanese Standards Association (JSA) Group
The Japanese Standards Association is a group centered around the General Incorporated Foundation Japanese Standards Association, established in December 1945 with the aim of developing, disseminating, and promoting standardization and management technologies. As Japan's comprehensive standardization body, our group undertakes various initiatives including the development of JIS, international standards (ISO/IEC standards), and JSA standards; the publication and sale of JIS standards; the distribution of international and overseas standards; the provision of diverse seminars; registration of various management systems such as ISO 9001 and ISO 14001; certification of various services; registration of qualifications for management system auditors; and the Quality Control Kentei (QC Kentei) examination.
■ What is 'ISO 10993-1'?
To introduce medical devices to the market, biological evaluation to prove safety for the human body is indispensable. At its core is 'ISO 10993-1'. ISO 10993-1 defines principles and requirements for evaluating the biological safety of devices within the broader risk management framework established by ISO 14971. It also provides guidelines to manufacturers and evaluators on the process of identifying, assessing, and managing biological risks related to materials, design choices, and tissue contact during the 'intended use' of the device.
■ Main Benefits of ISO 10993-1:2025
* Ensures patient and user safety through systematic biological risk assessment.
* Supports global regulatory compliance and market approval.
* Streamlines testing strategies and promotes the reduction of animal testing.
* Facilitates early detection and control of potential biological hazards during the design and development phases.
* Aligns biological evaluation with the ISO 14971 risk management process.
ISO 10993-1:2025: Biological evaluation of medical devices – Part 1: Requirements and general principles for evaluation of biological safety within a risk management process.
■ Main Changes in This Revision
* Overall structure completely revamped to further enhance alignment with ISO 14971.
* New guidance added regarding contact duration, material characterization, and identification of biological hazards.
* Terminology updated for greater clarity.
Purchase and details here.
Related Standards
ISO 10993-17:2023/Amd 1:2025 Amendment 1 – Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device components.
Main Changes in Amd 1:2025 (Amendment 1)
Amendment 1, issued in 2025, aims at technical fine-tuning and clarification of descriptions found after the operation started for the 2023 edition.
* Consistency of formulas: Corrected inconsistencies in calculation formulas and units when calculating toxicological risk (Margin of Safety: MOS).
* Refinement of terminology definitions: Adjusted wording to ensure consistency with other ISO 10993 series for specific terms used in the evaluation process.
* Supplement to Annexes: Specifies guidance for creating risk assessment reports.
Purchase and details here.
— What is an Amd (Amendment)? —
An Amd is issued when it is determined that new material needs to be added to an existing standard, or when editorial or technical corrections are made.
*Prices for standards may change. Please understand.
ISO Management System Special Page
JSA Library Server Service Details
(Department in charge: Customer Service Department, Sales Service Team; E-MAIL: csd@jsa.or.jp)
● About the Japanese Standards Association (JSA) Group
The Japanese Standards Association is a group centered around the General Incorporated Foundation Japanese Standards Association, established in December 1945 with the aim of developing, disseminating, and promoting standardization and management technologies. As Japan's comprehensive standardization body, our group undertakes various initiatives including the development of JIS, international standards (ISO/IEC standards), and JSA standards; the publication and sale of JIS standards; the distribution of international and overseas standards; the provision of diverse seminars; registration of various management systems such as ISO 9001 and ISO 14001; certification of various services; registration of qualifications for management system auditors; and the Quality Control Kentei (QC Kentei) examination.