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ISO 15193:2002

In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Presentation of reference measurement procedures

General information

Withdrawn from 28.04.2009
ICS Groups
11.100.10 In vitro diagnostic test systems
Directives or regulations
None

Standard history

Status
Date
Type
Name
28.04.2009
Main
ISO 15193:2009
Main
ISO 15193:2002
ISO 15193:2002 specifies requirements for the drafting of a reference measurement procedure.
It is applicable to any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

Required fields are indicated with *

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PDF
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Paper
125.87 € incl tax
Standard monitoring
English (PDF 587 KB)

Related products

Main

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
Newest version Valid from 28.04.2009
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EVS-EN ISO 18113-1:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Newest version Valid from 02.11.2011
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EVS-EN ISO 23640:2015

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
Newest version Valid from 02.07.2015
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EVS-EN ISO 18113-2:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
Newest version Valid from 02.11.2011

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English