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SSH EN ISO 15193:2009

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)

Oct 31, 2011

General information

60.60     Oct 31, 2011

DPS

DPS/KT 140

European Norm

11.100.10  

English  

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Scope

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.
ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15193:2009 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.

Related directives

Directives related to this standards.

98/79/EC

In vitro diagnostic medical devices

Harmonized
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Life cycle

PREVIOUSLY

Replaces
SSH EN 12286:2000

NOW

PUBLISHED
SSH EN ISO 15193:2009
60.60 Standard published
Oct 31, 2011

Related project

Adopted from EN ISO 15193:2009

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