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ASTM F2211-13(2021)
Standard Classification for Tissue-Engineered Medical Products (TEMPs)- 발행일 : 2021-09-15
- 발행기관 : ASTM
상세정보
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1?This classification outlines the aspects of tissue-engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies. 1.2?This classification does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271. 1.3?This standard does not purport to address specific components covered in other standards. Any safety areas associated with the medical product's use will not be addressed in this standard. 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. 1.4?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. |
| 국제분류(ICS)코드 | 11.100.99 : 약실험과 관련한 다른 표준 |
| 페이지수 | 8 |
| Edition | 13(2021) |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F2211-13(2021)상세보기 | Standard Classification for Tissue-Engineered Medical Products (TEMPs) | 2021-09-15 | 표준 |
| 2 | ASTM F2211-13상세보기 | Standard Classification for Tissue Engineered Medical Products (TEMPs) | 2013-10-01 | 구판 |
| 3 | ASTM F2211-04상세보기 | Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013) | 2004-10-01 | 구판 |
| 4 | ASTM F2211-02상세보기 | Standard Classification for Tissue Engineered Medical Products (TEMPs) | 2002-11-10 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
- ASTM F2312-11(2020) - Standard Terminology Relating to Tissue Engineered Medical Products
- ASTM F2383-11 - Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)
- ASTM F2791-15 - Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
- ASTM F2103-18 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
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