Safety evaluation of medical devices
著者
書誌事項
Safety evaluation of medical devices
Marcel Dekker, c2002
2nd ed.
- タイトル別名
-
Revised and expanded
大学図書館所蔵 全8件
  青森
  岩手
  宮城
  秋田
  山形
  福島
  茨城
  栃木
  群馬
  埼玉
  千葉
  東京
  神奈川
  新潟
  富山
  石川
  福井
  山梨
  長野
  岐阜
  静岡
  愛知
  三重
  滋賀
  京都
  大阪
  兵庫
  奈良
  和歌山
  鳥取
  島根
  岡山
  広島
  山口
  徳島
  香川
  愛媛
  高知
  福岡
  佐賀
  長崎
  熊本
  大分
  宮崎
  鹿児島
  沖縄
  韓国
  中国
  タイ
  イギリス
  ドイツ
  スイス
  フランス
  ベルギー
  オランダ
  スウェーデン
  ノルウェー
  アメリカ
内容説明・目次
内容説明
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.
The Third Edition explores these key current trends:
global device markets
continually advancing technology
the increasing harmonization of device safety regulation worldwide
Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.
目次
1. Introduction. I. Biocompatibility. II. Scope of Devices and the Medical Device Market. III. History. IV. Regulatory Considerations for NGO's and Secondary Regulators. 2. Regulatory Aspects and Strategies in Medical Device and Biomaterials Safety Evaluation. I. Regulatory Basis. II. Toxicity Testing: Medical Devices. 3. Road Map to Test Selections. I. Key concepts. II. Conditions of use. III. Materials, components, and products. IV. Prior knowledge. V. Types and Uses of Tests. 4. Materials in Medical Device Design. I. Introduction. II. Metals. III. Ceramics. IV. Polymers. V. Nanomaterials. 5. What to Test: Sampling and Sample Preparation. I. Sampling. II. Randomization. III. Sample Preparation. IV. Reference Materials. V. Conclusion. 6. Cytotoxicity Testing. I. Background. II. Cytotoxicity assays. III. Conclusion. 7. Hematocompatibiity. I. Introduction. II. Standard tests. III. Interpretation. IV. Specific Concern. V. Conclusion. 8. Local Tissue Tolerance. I. Dermal irritation. II. Ocular irritation testing. III. Other Nonparenteral Route Irritation Tests. IV. Parenteral Irritation/Tolerance. V. Parental Routes. VI. Intracutaneous Irritation. VII. Pyrogenicity. VIII. Problems in Testing (and Their Resolutions). 9. Immunotoxicology. I. Overview of the Immune System. II. Evaluation of the Immune System. III. Local Lymph Node Assay. III. Approaches. IV. Problems and Future Directions. 10. Implantation Biology and Studies. I. USP implantation Test. II. ISO 10993 Implantation Test. III. Test Method for Implantation in Subcutaneous Tissue. IV. Test Method for Implantation in Muscle. V. Test Method for Implantation in Bone. VI. Controls Materials. VII. Long-term Implant Studies. VIII. Considerations. 11. Acute Systemic Testing. 12. Genotoxicity. I. DNA structure. II. Mutagenicity. III. Cytogenetics. IV. In Vitro Cytogenetic Assays. V. In Vivo Cytogenetic Assays. VI. Sister Chromatid Exchange Assays. 13. Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity. I. Objectives. II. Regulatory considerations. III. Parameters to measure. IV. Histopathology. V. Study Interpretation and Reporting. VI. Reproductive and Developmental Toxicity. 14. Carcinogenicity. I. Animal models. II. Dose Selection. III. Interpretation of Results. 15. Degradation Products and Impurties. I. Introduction. II. Metals. III. Ceramics & Glasses. IV. Polymers. V. Effects of Sterilization. VI. Heavy Metals. 16. Combination Products. I.Combination Products. II. Principal Mode of Action (PMOA). III. Testing to serve two or more Regulatory Masters. 17. Clinical Studies for Medical Devices. I. Design considerations. II. Epidemiology. III. Conclusion. 18. Special Studies. I. Cardiovascular Devices and Prostheses. II. Tampons. III. Contact Lenses and Their Solutions. IV. Thrombogenicity. V. Twenty-One-Day Eye Irritation Study in Rabbits. VI. Systemic Injection Test. VII. Production of Toxic Shock Syndrome Toxin-1 (TSST-1). VIII. In Vitro Evaluation of the Effects of Potential Tampon Materials on PH And Growth of Vaginal Microflora. IX. Inflammatory Response to Biomaterials. 19. Toxicokinetics 20. Case Histories and Problem Resolution I. DEHP in devices. II. Dalkon Shield. III. Talc on Gloves and Condoms. IV. Toxic Shock Syndrome. V. Latex Allergy. VI. Silicone in Devices. VII. Drug Coded Stents. VIII. Antimicrobial Catheter. IX. Problem Solving. X. Risk Assessments. XI. Conclusion.
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