Understanding the Biological Safety of Medical Devices through Q&A 2026

Collecting "real questions from the field" submitted by practitioners, explained clearly in a Q&A format!

★Reflecting the revisions of ISO-10993, the number of questions has significantly increased from the previous 2014 edition【94 questions ⇒ 230 questions】. Directly addressing doubts and issues raised by practitioners! Experienced authors provide answers in a Q&A format. 〇 Organizing practical issues regarding test selection and necessity judgment, such as "Which tests should be conducted? Are there cases where they can be omitted?" 〇 Guidance on application and review processes, such as "At what stage and what should be prepared for PMDA correspondence?" 〇 Criteria for change management and comparative evaluation, such as "At what level should equivalence be judged?" 〇 Covering questions during testing, such as "How should in vitro/in vivo tests be differentiated?" 〇 Explaining evaluation and interpretation points, such as "How should the results of cytotoxicity, sensitization, and genotoxicity tests be evaluated?" 〇 Covering key points in test design that can be confusing in practice, such as "How should extraction conditions and sample selection be determined?" 〇 Addressing questions about global compliance and data utilization, such as "How much can overseas test data be used?" 〇 Explaining points on external contracting and practical operations, such as "How to choose a testing contractor and what to watch out for?"

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