11.100.30 标准查询与下载

BS EN 14820:2004 人类静脉血样品采集用一次性容器

This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture. This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.

Single-use containers for human venous blood specimen collection

EN 14820:2004 人类静脉血样品采集用一次性容器

This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture.This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirement

Single-use containers for human venous blood specimen collection

ASTM F2382-04(2010) 根据部分促凝血酶原激酶时间评估血管内医疗设备材料的标准试验方法

The purpose of this test method is to determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. In this test method, the test article is the activator. The PTT assay is a general screening test for medical material’s ability to activate the intrinsic coagulation pathway. Material samples that show a shortened PTT are activators of the intrinsic coagulation pathway. Test samples that show a shortened PTT are activators of the intrinsic coagulation pathway. The results are reported as a percent of the negative control. The test article, reference materials, and controls are exposed to human plasma. The plasma is tested on a coagulation device. Each sample tube is assayed in duplicate.1.1 This test method covers the screening of cardiovascular 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 labeled with the contents, and disposed 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 universal 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

DIN 58932-4:2003 血液学.血液血细胞浓度测定.第4部分:白细胞浓度测定比对程序

The standard specifies a reference procedure for the determination of the leucocyte concentration in human blood. This standard also applies to corpuscle counting in stabilised control bloods containing fixed human or animal blood corpuscles or particles of non-biological origin, e. g. beads, if the metrological behaviour of the corpuscles to be measured corresponds to that of leucocytes.

Haematology - Determination of the concentration of blood corpuscles in blood - Part 4: Reference procedure for the determination of the concentration of leucocytes

ISO 15197:2003 体外诊断试验系统.糖尿病症管理中自测用血糖监测系统的要求

This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus. This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not — provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, — pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus, — address the medical aspects of diabetes mellitus management, or — apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

AS 4985:2002 痕量和有毒元素定量用尿样的收集和稳定

Sets out procedures for the pre-treatment of the urine containers and procedures for the collection of urine for the determination of antimony, arsenic, bismuth, cadmium, calcium, cobalt, copper, iron, lead, magnesium, mercury, nickel, selenium, thallium and zinc.

Collection and stabilization of urine samples for quantitation of trace and toxic elements

DIN 58930:2002 止血法.INR定标血浆.要求、制备和使用

The document is applicable to lyophilized plasmas for the INR calibration of the thromboplastin (prothrombin) time for monitoring oral anticoagulant therapy. Its aim is to enable different users to arrive at comparable INR values for patient samples.

Haemostaseology - INR calibration plasmas - Requirements, preparation and use

DIN 58910-1:2000 止血学.促凝血酶原激酶时间的测定.第1部分:测定含枸橼酸盐的静脉血中血浆的参考测量方法

Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood

DIN 58910-3:2000 止血学.促凝血酶原激酶时间的测定.第3部分:含枸橼酸盐的毛细血液测定的参考测量方法

The document is applicable to the determination of the thromboplastin (prothrombin) time (PT) in citrated capillary blood.

Haemostaseology - Determination of the thromboplastin (prothrombin) time - Part 3: Reference measurement procedure for the determination in citrated capillary blood

DIN 58910-4:2000 止血学.促凝血酶原激酶时间的测定.第4部分:测定毛细血液的参考测量方法

The document is applicable to the determination of the thromboplastin (prothrombin) time (PT) in capillary blood.

Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 4: Reference measurement procedure for the determination in capillary blood

DIN 58911-1:2000 止血学.测量方法的校准.凝固时间测量法

Thes document is applicable to the calibration of clotting time measurement procedures using calibration plasmas. The calibation can be carried out with the aid of serial dilutions of a defined normal plasma (activity = 100 % or 1 IU/ml) or of a calibration plasma or with the aid of several calibration plasmas with an exactly determined activity or concentration of the coagulant constituent to be analyzed (e.g. fibrinogen in g/1).

Haemostaseology - Calibration of measurement procedures - Part 1: Clotting time measurement procedures

DIN 58911-2:2000 止血学.测量方法的校准.第2部分:光度测量法

The document is applicable to the calibration of photometric measurement procedures in the field of haemostaseology. The calibration can be carried out with the aid of serial dilutions of a defined normal plasma (aktivity = 100 % or 1 IU/ml) or of a calibration plasma or with the aid of several undiluted calibration plasmas with an exactly determined activity or concentration of the coagulant constituent to be analyzed (e.g. fibrinogen in g/l).

Haemostaseology - Calibration of measurement procedures - Part 2: Photometric measurement procedures

DIN 58912-1:2000 止血学.抗凝血酶III活性的测定.第1部分:用合成肽底物测定

The document is applicable to the functional determination of the antithrombin III activity as heparin cofactor activity with regard to thrombin. The purpose of this document is to establish comparable results of the antithrombin III activity of a sample. This determination is mainly used in the diagnosis of thrombophilic diathesis as well as for monitoring a substitution therapy and for the determination of the activity in antithrombin III concentrates.

Haemostaseology - Determination of the antithrombin III activity - Part 1: Reference measurement procedure using a synthetic peptide substrate

DIN 58913-1:2000 止血学.凝血因子II凝固活性(F II C)及凝血因子X凝固活性(F X C)的测定.第1部分:一段法用的参考测量法

The document is applicable to the determination of factor II and factor X coagulant activity in plasma and factor concentrates by the one-stage method. The purpose of this document is to achieve comparable results for the factor II C and factor X C content in a given specimen. Essential precondition for archieving this objective are a standardized procedure for calibration of the method, as well as the use of reference plasmas or reference concentrates with declared factor II C and factor X C proportion, respectively, which has been determined by calibration against the International Standard of WHO for factor II C and factor X C, respectively, which is valid at the time of use.#,,#

Haemostaseology - Determination of factor II coagulant activity (F II C) and factor X coagulant activity (F X C) - Part 1: Reference measurement procedure for the one-stage method

DIN 58914-1:2000 止血学.凝血致活酶时间的测定.第1部分:测定含枸橼酸盐的静脉血中血浆的参考测量方法

Haemostaseology - Determination of thrombin time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood

DIN 58939-1:2000 止血学.基准血浆.第1部分:要求和制备

The document is applicable to the preparation and storage of a reference plasma in the field of haemostaseology.

Haemostaseology - Reference plasma - Part 1: Requirements, preparation

DIN 58910-2:2000 止血学.促凝血酶原激酶时间的测定.第2部分:测定含枸橼酸盐的静脉血的参考测量方法

The document is applicable to the determination of the thromboplastin (prothrombin) time (PT) in citrated venous blood.

Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 2: Reference measurement procedure for the determination in citrated venous blood

DIN 58909-2:2000 止血学.测定Ⅷ凝血活性系数(FⅧ:C).合成肽底物参考测量方法

The document is applicable to the determination of factor VIII coagulant activity (F VIII C) via the determination of factor Xa with a chromogenic peptide substrate in plasma and factor concentrates. The purpose of this document is to achieve comparable results for the factor VIII content in a given specimen. Essential preconditions for achieving this objective are a standardized procedure for calibration of the method, as well as the use of reference plasmas or reference concentrates with an assigned factor VIII C proportion which has been determined by calibration against the International Standard of WHO for factor VIII C which is valid at the time of use.#,,#

Haemostaseology - Determination of factor VIII coagulant activity (F VIII C) - Part 2: Reference measurement procedure using a synthetic peptide substrate

DIN 58909-1:2000 止血学.测定凝血因子Ⅷ凝血活性系数(FⅧ:C).第1部分:一个阶段法的参考测量方法

The document is applicable to the determination of factor VIII coagulant activity in plasma and factor concentrates by the one-stage method. The purpose of this document is to achieve comparable results for the factor VIII content in a given specimen.

Haemostaseology - Determination of factor VIII coagulant activity (F VIII C) - Part 1: Reference measurement procedure for the one-stage method

DIN 58908:2000 止血学.激活部分促T凝血酶原激酶时间的测定(APTT).参考测量方法

The document is applicable to the determination of the activated partial thromboplastin time (APTT) in plasma obtained from citrated venous blood.

Haemostaseology - Determination of activated partial thromboplastin time (APTT) - Reference measurement procedure