Biological Safety of Medical Devices 2026

¥55 ,000

This book reflects the revisions of ISO-10993 and significantly increases the number of questions from the previous 2014 edition, expanding from 94 to 230 questions. It addresses inquiries and challenges directly from practitioners in the field. Experienced authors provide answers in a Q&A format, making it a valuable resource for those involved in biological safety evaluation, test design, and approval applications within medical device manufacturing.

This is a request, not an immediate purchase. Your card is authorized but not charged. Delivery takes about one week. We capture payment when the English PDF is ready.

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Description

This is a request, not an immediate purchase. Delivery takes about one week. Your card is authorized but not charged until the English PDF is ready.

Product ID: 1163

Publisher: Johokiko

Publication Date: 2026-04-20

English Summary

This book reflects the revisions of ISO-10993 and significantly increases the number of questions from the previous 2014 edition, expanding from 94 to 230 questions. It addresses inquiries and challenges directly from practitioners in the field. Experienced authors provide answers in a Q&A format, making it a valuable resource for those involved in biological safety evaluation, test design, and approval applications within medical device manufacturing.

Contents / Coverage

  • Chapter 1: Domestic Regulations and International Regulations
  • Chapter 2: Risk Assessment and Risk Management
  • Chapter 3: Medical Device GLP and Test Contracting
  • Chapter 4: Physicochemical Information
  • Chapter 5: Selection and Extraction of Test Substances
  • Chapter 6: Biological Safety Testing and Animal Welfare

Why This May Matter Internationally

The book is relevant for professionals dealing with biological safety assessments and regulatory compliance in the medical device industry, particularly in relation to ISO 10993 and various international regulations.

Keywords: medical devices,biological safety,ISO 10993,regulatory compliance,Q&A,Johokiko

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