11.100.30 标准查询与下载
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Standard Practice for Platelet Leukocyte Count — An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials
- ICS
- 11.100.30
- CCS
- 发布
- 2023-05-03
- 实施
This specification covers disposable blood sedimentation tubes suitable for determining sedimentation rates and the volume of packed red blood cells. This specification covers a tube intended for one-time use only. The tubes shall be fabricated borosilicate glass, Type I, Class B, or from soda lime glass, Type II. The tubes shall be tested for their marking permanency and resistance to centrifugal test.
Standard Specification for Blood Sedimentation Tube, Wintrobe, Glass, Disposable
- ICS
- 11.100.30
- CCS
- 发布
- 2021-07-01
- 实施
This specification covers two dimensionally different (short and long) disposable glass micropipets used primarily to collect whole human blood specimens for clinical analysis and testing. Short and long pipets are available as coated with heparin (Type I) or uncoated (Type II).The pipets shall be fabricated from borosilicate glass, Type I, Class B, or soda lime glass, Type II. Heparin shall be the ammonium salt isolated from the lungs or intestinal mucosa of beef or pork origin and shall meet the specified heparin potency. The physical requirements including design, dimensions, workmanship, color coding, capillarity, fluidity, lot or control number, resistance to centrifugal force, and heparin coating are specified. The following tests shall be performed: capillarity test, fluidity test, sheep plasma test, human whole blood test, resistance to centrifugal force test, and heparin content test. The physical requirements for short Caraway pipet and long Natelson pipet are illustrated as well.
Standard Specification for Disposable Glass Micro Blood Collection Pipets
- ICS
- 11.100.30
- CCS
- 发布
- 2021-07-01
- 实施
This specification describes the physical requirements and corresponding test methods for disposable glass blood sample capillary tubes for use in microhematocrit procedures. Covered here are two different types of capillary tubes, namely, Type I (coated with heparin), and Type II (uncoated). The tubes shall be fabricated from Type I, Class B borosilicate glass, or Type II soda lime glass. Conversely, the heparin used for coating Type I tubes shall be of ammonium salt isolated from the lungs or intestinal mucosa of beef or pork origin. The tubes shall conform to specified requirements for design, dimension, workmanship, color coding, and lot or control number. They should also pass the following tests for capillarity, fluidity, sheep plasma, positive and negative controls, human whole blood, heparin potency assay, and resistance to centrifugal force.
Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)
- ICS
- 11.100.30
- CCS
- 发布
- 2021-07-01
- 实施
This specification covers reusable blood sedimentation tubes suitable for determining sedimentation rates and the volume of packed red blood cells. The tubes shall be fabricated from borosilicate glass, Type I, Class B, or sodalime glass, Type II. A resistance to centrifugal force test shall be performed on the tubes.
Standard Specification for Blood Sedimentation Tube, Wintrobe, Glass, Reusable
- ICS
- 11.100.30
- CCS
- 发布
- 2021-07-01
- 实施
Haematology - Determination of the concentration of blood corpuscles in blood - Part 3: Reference method for the determination of the concentration of erythrozytes; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2017-01
- 实施
Haemostaseology - Blood collection - Part 1: Preparation of plasma from citrated venous blood for coagulation testing; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2016-12
- 实施
Haemostaseology - Determination of thromboplastin (prothrombin) time - Part 1: Reference measurement procedure for the determination in plasma from citrated venous blood; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2016-02
- 实施
3.1 This guide provides information for the sampling of seized-drug submissions. 3.2 The principal purpose of sampling in the context of this guide is to answer relevant questions about a population by examination of a portion of the population. For example: What is the net weight of the population? What portion of the units of a population can be said to contain a given drug at a given level of confidence? 3.3 By developing a sampling strategy and implementing appropriate sampling schemes, as illustrated in Fig. 1, a laboratory will minimize the total number of required analytical determinations, while ensuring that all relevant legal and scientific requirements are met. 1.1 This guide covers minimum considerations for sampling of seized drugs for qualitative and quantitative analysis. 1.2 This guide cannot replace knowledge, skill, or ability acquired through appropriate education, training, and experience and should be used in conjunction with sound professional judgment.
Standard Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis
- ICS
- 11.100.30
- CCS
- 发布
- 2016
- 实施
Haemostaseology - Determination of activated partial thromboplastin time (APTT) - Reference measurement procedure; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2015-09
- 实施
Haemostaseology - Determination of the antithrombin activity - Part 1: Reference measurement procedure using a synthetic peptide substrate
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2015-09
- 实施
Technical Report - Thrombocyte diagnostics
- ICS
- 11.100.30
- CCS
- C44
- 发布
- 2013-04
- 实施
Haematology - Determination of the concentration of blood corpuscles in blood - Part 1: Blood collection, sample preparation, biological influence factors, interference factors; Text in German and English
- ICS
- 11.100.30
- CCS
- C44
- 发布
- 2012-04-01
- 实施
Single-use containers for venous blood specimen collection. Technical requirements and test methods
- ICS
- 11.100.30
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
This standard applies to the determination of the number or the size distribution, respectively, of the multimeres of the human von Willebrand factor as well as the assessment of the substructures of the VWF multimeres in citrated plasmas or in factor concentrations.
Haemostaseology - Reference method for the VWF multimeres; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2010-03
- 实施
This standard applies to the immunological determination of the von Willebrand factor antigen concentration (VWF:Ag) in citrated plasmas and factor concentrations. The reference methods chosen are the ELISA technique and the automated particle-enhanced agglutination.
Haemostaseology - Reference method for the VWF antigen; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2010-03
- 实施
This standard applies to the determination of the functional collagen binding activity of the human von Willebrand factor in citrated plasma and of purified plasmatic or recombinant von Willebrand factor in pharmaceutical preparations.
Haemostaseology - Reference method for the determination of the collagen binding acitvity of the VWF; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2009-05
- 实施
This standard applies to the determination of the functional activity of the von Willebrand factor (VWF) in citrated plasmas and plasma concentrates by means of the ristocetin-induced thrombocyte agglutination [ristocetin cofactor (RCo) activity, von Willebrand factor ristocetin cofactor activity (VWF:RCo)].
Haemostaseology - Reference method for the ristocetin-cofactor activity of the VWF; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2009-05
- 实施
Haematology - Determination of the concentration of blood corpuscles in blood - Part 5: Reference method for the determination of the concentration of thrombocytes; Text in German and English
- ICS
- 11.100.30
- CCS
- C05
- 发布
- 2007-10
- 实施
Single-use containers for venous blood specimen collection.
- ICS
- 11.100.30
- CCS
- C31
- 发布
- 2005-02-01
- 实施
- 2005-02-20
