ASTM F2382-2018 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT).pdf
《ASTM F2382-2018 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT).pdf》由会员分享,可在线阅读,更多相关《ASTM F2382-2018 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT).pdf(4页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F2382 18Standard Test Method forAssessment of Circulating Blood-Contacting Medical DeviceMaterials on Partial Thromboplastin Time (PTT)1This standard is issued under the fixed designation F2382; the number immediately following the designation indicates the year oforiginal adoption or,
2、in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers the screening of circulatingblood-contacting device mater
3、ials for their ability to induceblood coagulation via the intrinsic coagulation pathway. Thisassay should be part of the hemocompatibility evaluation fordevices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.1.2 All safety policies and practices shall be observedduring the perfor
4、mance of this test method.1.3 All plasma and any materials that had contact withplasma will be bagged in a biohazard bag, properly labelledwith the contents, and disposed of by appropriate means. Theplasma should be handled at the Biosafety Level 2 as recom-mended in the Centers for Disease Control/
5、National Institutesof Health Manual Biosafety in Microbiological Laboratories.1.4 The normal pooled human plasma must have testednegative for Hepatitis B (HBV) or Human Immunodeficiency(HIV) viruses. The plasmas should be treated like any patientplasma using standard precautions. The plasma should b
6、ehandled at the Biosafety Level 2 as recommended in theCenters for Disease Control/National Institutes of HealthManual Biosafety in Microbiological Laboratories.1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 This standa
7、rd does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.7 This inter
8、national standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) C
9、ommittee.2. Referenced Documents2.1 ANSI/AAMI Standard:ANSI/AAMI/ISO 10993-4 Biological Evaluation of MedicalDevicesPart 4: Selection of Tests for Interactions withBlood22.2 Other Document:U.S. Department of Health and Human Services Biosafety inMicrobiological and Biomedical Laboratories (BMBL),5th
10、 ed., 199933. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 activatora medical material which demonstrates ashortened clotting time; an initiator of the intrinsic coagulationpathway.3.1.2 partial thromboplastin time (PTT) assaya modifica-tion of the Activated Partial Thrombopla
11、stin Time (APTT)assay; unlike the APTT test, the PTT assay uses a reagent(rabbit brain cephalin) without activating substances such assilica, kaolin, elagic acid. The material being tested acts as theactivator.3.1.3 read timethe time during which data is collected todetect a clot.3.1.4 blank timea p
12、eriod at the beginning of an assaywhen no data is taken. This is done to eliminate interferencefrom premixing reagents, bubbles, and so forth.3.1.5 equilibration timethe time allowed for the plasmasamples to warm to 37C. The coagulation analyzer can be setto zero if samples are pre-warmed to this te
13、mperature.3.1.6 duplicate flagthe agreement between the results ofduplicate samples in percent. For example, if set to “15,” thedifference between the two channels must be less than or equal1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices
14、 and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Oct. 1, 2018. Published October 2018. Originallyapproved in 2004. Last previous edition approved in 2017 as F2382 171. DOI:10.1520/F2382-18.2Available from American National Standards In
15、stitute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.3The BMBL 5th Edition (December 2009) is available from the GovernmentPrinting Office or https:/www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdfCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Con
16、shohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade O
17、rganization Technical Barriers to Trade (TBT) Committee.1to 15 %. If the variance in clot times exceeds this percentage,an asterisk “*” will be printed by the average results on thereport.4. Significance and Use4.1 The purpose of this test method is to determine the timecitrated plasma exposed to me
18、dical materials takes to form aclot when exposed to a suspension of phospholipid particlesand calcium chloride. In this test method, the test article is theactivator. The PTT assay is a general screening test for amedical materials ability to activate the intrinsic coagulationpathway. Material sampl
19、es that show a shortened PTT areactivators of the intrinsic coagulation pathway.4.2 The test article, reference materials, and controls areexposed to human plasma. The plasma is tested on a coagula-tion device. Each sample tube is assayed in duplicate. Theresults are reported as a percentage of the
20、negative control.5. Apparatus5.1 Polypropylene Test Tubes with Caps, 12 by 75 mm.5.2 Automatic Pipets and Tips, 100 and 1000 L.5.3 Ice Bath.5.4 Coagulation Analyzer qualified, see A1.1.5.5 Agitating Water Bath, 37 6 2C, capable of 60 rpm.5.6 Coagulation Analyzer Cuvettes, or equivalent for spe-cific
21、 analyzer.6. Reagents and Materials6.1 Calcium Chloride, 25 mM.6.2 Citrated Human Blood Plasma, fresh (less than 4 h fromdraw) or freshly-frozen, maintained at minus 80C, pooled.6.3 Lyophilized Rabbit Brain Cephalin (RBC).6.4 Positive Reference Material (Optional), see A1.2.6.5 Positive Control, gla
22、ss (Pasteur pipette tips or glassbeads). Other qualified positive control materials such asBuna-N-Rubber may be selected once they have demonstrateda consistent thrombogenic response.6.6 Negative Reference Material (e.g. High DensityPolyethylene, HDPE).6.7 Marketed Comparator Device (Optional). A le
23、gallymarketed, clinically acceptable device that has similar bloodcontact nature and clinical use as the material/device beinginvestigated.NOTE 1It may be helpful to use a positive reference control material(n=1) per assay to assure continuity between runs.7. Hazards7.1 The human blood plasma should
24、 be treated like anypatient plasma using standard precautions. The plasma shouldbe handled at the Biosafety Level 2 as recommended in the USDepartment of Health and Human Services Biosafety inMicrobiological and Biomedical Laboratories.8. Preparation of Apparatus8.1 Prepare each test article, the ne
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
10000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ASTMF23822018STANDARDTESTMETHODFORASSESSMENTOFCIRCULATINGBLOODCONTACTINGMEDICALDEVICEMATERIALSONPARTIALTHROMBOPLASTINTIMEPTTPDF

链接地址:http://www.mydoc123.com/p-1243955.html