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ASTM F2382-18
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)- 발행일 : 2018-10-01
- 발행기관 : ASTM
상세정보
| 분야 | 13.01 : 의료기, 외과용 도구 및 장비 |
|---|---|
| 적용범위 | 1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4. 1.2 All safety policies and practices shall be observed during the performance of this test method. 1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. 1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 : 약실험
11.100.30 : 혈액 및 소변 분석 |
| 페이지수 | 4 |
| Edition | 18 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F2382-24상세보기 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) | 2024-08-15 | 표준 |
| 2 | ASTM F2382-24 REDLINE상세보기 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) | 2024-08-15 | 표준 |
| 3 | ASTM F2382-18상세보기 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) | 2018-10-01 | 구판 |
| 4 | ASTM F2382-18 REDLINE상세보기 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) | 2018-10-01 | 구판 |
| 5 | ASTM F2382-17e1상세보기 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) | 2017-09-01 | 구판 |
| 6 | ASTM F2382-17상세보기 | Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) | 2017-09-01 | 구판 |
| 7 | ASTM F2382-04(2010)상세보기 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) | 2010-06-01 | 구판 |
| 8 | ASTM F2382-04e1상세보기 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) | 2004-05-01 | 구판 |
| 9 | ASTM F2382-04상세보기 | Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) | 2004-05-01 | 구판 |
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- 관련상품이 존재하지 않습니다.
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