Japanese translation of standard for biological evaluation of medical devices published
Japanese Standards Association Press Release: October 22, 2025 Japanese translation of standard for biological evaluation of medical devices published ~A must-have for medical device manufacturers! ～ The Japanese Standards Association
(Headquarters: Minato-ku, Tokyo; Chairman: Hiroshi Asahi) published Japanese translations of standards for biological evaluation of medical devices on Wednesday, October 1, 2025, and Wednesday, October 15, 2025. ▼Standard information
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preparation and reference materials — Amendment 1 《English》Price including tax: 3,762 yen, A4 size, 2 pages 《Japanese Translation (English/Japanese)》Price including tax: 7,524 yen, A4 size, 14 pages This standard is Amendment 1 to ISO 10993-2:2021. ISO 10993-2:2021 specifies requirements and outlines procedures for sample preparation and reference material selection for medical device testing, primarily for biological test systems. In particular, it addresses the following: ・Selection of test samples ・Selection of representative parts of medical devices ・Test Sample Preparation ・Experimental Control ・Reference Material Selection and Requirements ・Preparation of extract -What is Amd (Amendment)? — Issued when it is deemed necessary to add new material to an existing standard or when editorial or technical corrections are made. Click here for purchase and details -What is the purpose of ISO 10993-12:2021? When conducting biological tests to determine whether a medical device is safe for the human body, this document defines very important procedures that are the basis for the test: how to prepare the test sample and what reference substance (comparison object) should be used. ISO 10993-12:2021 This standard is included in the ISO 10993 series of standards. Click below to view the included standards or to purchase the standard. Click here for the ISO 10993 series standards
▼Standard information
https://prcdn.freetls.fastly.net/release_image/4052/467/4052-467-7fcc0a4c0bd241fc3c3df0f6dbfcb30a-1209×1697.png BS EN ISO 10993-23:2021 A1:2025 Biological evaluation of medical devices – Part 23: Irritation tests Biological evaluation of medical devices – Tests for irritation 《English》Price including tax: 79,860 yen, A4 size, 78 pages 《Japanese translation (English/Japanese)》Price including tax: 111,804 yen, A4 size, 154 pages This standard provides a framework for evaluating the potential risk of irritation, such as inflammation or redness, when a medical device comes into contact with body tissues, such as the skin, mucous membranes, or eyes. Click here for purchase and details Purpose of BS EN ISO 10993-23:2021 By promoting the latest scientifically valid testing methods, this standard enables the efficient and ethical evaluation of medical device safety using data that is more easily extrapolated to humans, while taking animal welfare into consideration. Information on related standards ▼Standard information
https://prcdn.freetls.fastly.net/release_image/4052/467/4052-467-f3ffc54ab6ae6efb5bd374b1cbf77afc-1779×2514.jpg BS EN ISO 10993-12:2021 Biological evaluation of medical devices – Sample preparation and reference materials Biological evaluation of medical devices – Sample preparation and reference materials [English] Please contact us at csd@jsa.or.jp. 《Japanese Translation
(English/Japanese)》Price including tax: 87,406 yen, A4 size, 66 pages This standard is the UK implementation of EN ISO 10993-12:2021 and is a part of the ISO This is a conforming standard to 10993-2:2021. Click here for purchase and details We also publish the latest version, which includes supplements. *Only the English version is available. Click here for the latest
version *Prices of specifications may change. Thank you for your understanding. (Responsible Department: Customer Service Department, Sales Service Team, E-MAIL: csd@jsa.or.jp)
https://prcdn.freetls.fastly.net/release_image/4052/467/4052-467-198f4d300c6d3cc1936db95b874297f3-1299×285.png ●About the Japanese Standards Association (JSA) Group This group is centered around the Japan Standards Association, a general
incorporated foundation established in December 1945 for the purpose of developing, disseminating, and raising awareness of standardization and management technologies. As Japan’s comprehensive standardization organization, our group is engaged in a wide range of activities, including the development of JIS, international standards (ISO and IEC standards), and JSA standards; the publication and sale of JIS standard sheets; the distribution of international and overseas standards; the provision of a variety of seminars; the audit and registration of various management systems, including ISO 9001 and ISO 14001; certification of various services; the registration of qualifications such as management system auditors; and quality control certification (QC certification).