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EVS-EN ISO 19001:2013

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

General information

Valid from 02.04.2013
Base Documents
ISO 19001:2013; EN ISO 19001:2013
ICS Groups
11.040.55 Diagnostic equipment 11.100.10 In vitro diagnostic test systems
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.04.2013
Main
EVS-EN ISO 19001:2013
Main
EVS-EN 12376:2001
This International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in biology. The requirements for information supplied by the manufacturer specified in this International Standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

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Standard monitoring
English (PDF 364 KB)

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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