Schuh Joann C L
Applied Veterinary Pathobiology PLLC, Bainbridge Island, Washington 98110-3663, USA.
Toxicol Pathol. 2008 Jan;36(1):63-9. doi: 10.1177/0192623307309926.
Awareness of the regulatory environment is fundamental to understanding the biological assessment of biomaterials and medical devices. Medical devices are a diverse and heterogeneous group of medical products and technologies defined by the lack of chemical action or requirement for metabolism. Regional activity and the Global Harmonization Task Force are now working on harmonizing the categorization and testing of medical devices. The International Organization for Standardization (ISO) has published 19 standards for biological evaluation. ISO 10993 standards are generally accepted outright or as an alternative to most national regulatory directives or acts, although Japan and the United States require more stringency in some tests. Type of materials, intended use, and risk are the basis for drafting testing programs for biomaterials and medical devices. With growth of the medical device industry and advent of new biomaterials and technologies, the need for toxicologic pathologists in safety (biocompatibility) and efficacy (conditions of use) evaluation of moderate- to high-risk devices is expanding. Preclinical evaluation of biomaterials and medical devices increasingly requires a basic understanding of materials science and bioengineering to facilitate interpretation of complex interface reactions between biomaterials, cellular and secretory factors, and vascular and tissue responses that modulate success or failure of medical devices.
了解监管环境是理解生物材料和医疗器械生物学评估的基础。医疗器械是一类多样且异质的医疗产品和技术，其定义为缺乏化学作用或无需新陈代谢。区域活动和全球协调工作组目前正在致力于协调医疗器械的分类和测试。国际标准化组织（ISO）已发布了19项生物评价标准。ISO 10993标准通常被直接接受，或作为大多数国家监管指令或法案的替代标准，不过日本和美国在某些测试方面要求更为严格。材料类型、预期用途和风险是起草生物材料和医疗器械测试方案的基础。随着医疗器械行业的发展以及新生物材料和技术的出现，对毒理病理学家进行中高风险器械安全性（生物相容性）和有效性（使用条件）评估的需求正在不断扩大。生物材料和医疗器械的临床前评估越来越需要对材料科学和生物工程有基本的了解，以便于解释生物材料、细胞和分泌因子以及血管和组织反应之间复杂的界面反应，这些反应会调节医疗器械的成败。
