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?"
Inquire About This Product
basic information
Publication scheduled for the end of April 2026 Format: B5 size, 348 pages ISBN: Book version: 978-4-86502-298-8 PDF version (CD-ROM): 978-4-86502-308-4
Price information
List price: Book version or PDF version (CD-ROM): 49,500 yen (including tax (10% consumption tax)) Book version + PDF version (CD-ROM) set: 60,500 yen (including tax (10% consumption tax))
Price range
P2
Delivery Time
P1
※Orders placed by 3 PM will be shipped on the same day.
Applications/Examples of results
It caters to a wide range of applications, from educational materials for beginners to guides for experienced professionals. 【Target Audience】 - Development, quality, and regulatory personnel involved in biological safety evaluation, test design, and approval applications at medical device manufacturers. - Practitioners struggling to comply with ISO 10993 and domestic and international regulations. - On-site personnel facing challenges with practical decision-making, such as determining the necessity of tests, outsourcing, and preparing application documents.
catalog（1）
Download All Catalogs
Company information
The information organization aims to contribute to the development of the industry through technical seminars on chemistry, pharmaceuticals, electronics, machinery, environment, cosmetics, food, etc., as well as the publication of technical books, correspondence courses, and DVDs that record seminars.
![[Data] Classification of Non-Water-Soluble Cutting Oils as Hazardous Materials / Apiste](https://image.mono.ipros.com/public/product/image/f26/2000645264/IPROS02613700727502226673.jpeg?w=280&h=280)
