Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
ASTM F3225-17
Năm ban hành 2017
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
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Chỉ số phân loại Quốc tế (ICS)
By field |
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Số trang
Page 7
Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard 1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, shunting and/or bypass of blood vessels. This guide is intended for use related to the in vitro assessment of TEMP vascular grafts. In vitro cellular characterization and in vivo testing are not within scope for this standard guide. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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