| C46-A2 (Paper Document) |
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Blood Gas and pH Analysis and Related Measurements; Approved Guideline-Second EditionPreview Sample PagesThis document provides clear definitions of the quantities in current use, and provides a single source of information on appropriate specimen collection, preanalytical variables, calibration, and quality control for blood pH and gas analysis and related measurements. Electrolytes, fractional hemoglobins, hemoglobin-oxygen saturation, metabolites, oxygen content, partial pressure of carbon dioxide, partial pressure of oxygen, pH
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| C53-P (Electronic Document) |
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Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Proposed GuidelinePreview Sample Pages This document provides information to help material manufacturers in the production and characterization of commutable reference materials as well as assist assay manufacturers, proficiency testing providers, and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices. Commutability, homogeneity assessment, material qualification, reference material, stability assessment
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60.00
Non-member price: $
120.00
Your price: $ 120.00
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| C53-P (Paper Document) |
 |
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Proposed GuidelinePreview Sample Pages This document provides information to help material manufacturers in the production and characterization of commutable reference materials as well as assist assay manufacturers, proficiency testing providers, and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices. Commutability, homogeneity assessment, material qualification, reference material, stability assessment
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60.00
Non-member price: $
120.00
Your price: $ 120.00
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| EP05-A2 (Electronic Document) |
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Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second EditionPreview Sample Pages This document provides guidance for designing an experiment to evaluate the precision performance of quantitative measurement methods; recommendations on comparing the resulting precision estimates with manufacturers' precision performance claims and determining when such comparisons are valid; as well as manufacturers' guidelines for establishing claims. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.Evaluation protocol, experimental design, medical devices, outlier, precision, quality control
Member price: $
85.00
Non-member price: $
200.00
Your price: $ 200.00
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| EP05-A2 (Paper Document) |
|
Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second EditionPreview Sample Pages This document provides guidance for designing an experiment to evaluate the precision performance of quantitative measurement methods; recommendations on comparing the resulting precision estimates with manufacturers' precision performance claims and determining when such comparisons are valid; as well as manufacturers' guidelines for establishing claims. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.Evaluation protocol, experimental design, medical devices, outlier, precision, quality control
Member price: $
85.00
Non-member price: $
200.00
Your price: $ 200.00
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