SS-EN-ISO-18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

SS-EN-ISO-18153 - 2004 EDITION - CURRENT


Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:


This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of this standard: a) requirements for the design or selection of a reference measurement procedure; b) quantities involving mass of enzyme or immunoreactivity of enzymes; c) control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); d) control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; e) metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; f) properties involving nominal and ordinal scales.

To find similar documents by classification:

07.100.10 (Medical microbiology Laboratory medicine, see 11.100)

11.100.10 (In vitro diagnostic test systems)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

SOR/98-282
Medical Devices Regulations (Canada)

21CFR(820)
Code of Federal Regulations - FDA, Food and Drug Administration - Quality System Regulation

BS-EN-ISO-15223-1
Medical devices. Symbols to be used with information to be supplied by the manufacturer

ORDER

Price:

$156.75        


Want this as a site license?



Designation Name

SS-EN ISO 18153:2004

Revision Level

2004 EDITION

Status

Current

Publication Date

Oct. 8, 2004

Language(s)

English

Page Count

17

International Equivalent

EN ISO 18153:2003(IDT); ISO 18153:2004(IDT)