SS-EN-ISO-15193 › In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
SS-EN-ISO-15193
-
2009 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:
The following bibliographic material is provided to assist you with your purchasing decision:
This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, international measurement standard designates a material standard. The term international standard is used by WHO for reference materials.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
In vitro diagnostic medical devices
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/98-282Medical 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
Designation Name
SS-EN ISO 15193:2009
Revision Level
2009 EDITION
Status
Current
Publication Date
May 25, 2009
Language(s)
English
Page Count
36
International Equivalent
EN ISO 15193:2009(IDT); ISO 15193:2009(IDT)