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ISO 19001:2013

Current
Current

The latest, up-to-date edition.

In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

03-07-2013

Publisher

International Organization for Standardization

ISO 19001:2013 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 histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in ISO 19001:2013 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

Committee
ISO/TC 212
DevelopmentNote
Supersedes ISO/DIS 19001. (03/2013)
DocumentType
Standard
Pages
14
PublisherName
International Organization for Standardization
Status
Current
Supersedes

PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
UNE-EN ISO 21572:2013 Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)
ISO 14971:2007 Medical devices Application of risk management to medical devices
CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
UNE-ISO 28004:2014 Security management systems for the supply chain. Guidelines for the implementation of ISO 28000
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
DIN EN ISO 21572 E : 2013 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS (ISO 21572:2013)
I.S. EN ISO 21572:2013 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS (ISO 21572:2013)
10/30143797 DC : 0 BS ISO/IEC 24760-1 - INFROMATION TECHNOLOGY - SECURITY TECHNIQUES - A FRAMEWORK FOR IDENTITY MANAGEMENT - PART 1: TERMINOLOGY AND CONCEPTS
UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
BS EN ISO 21572:2013 Foodstuffs. Molecular biomarker analysis. Protein-based methods
UNI EN ISO 21572 : 2013 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS
ISO 21572:2013 Foodstuffs Molecular biomarker analysis Protein-based methods
DIN EN ISO 21572:2013-06 FOODSTUFFS - MOLECULAR BIOMARKER ANALYSIS - PROTEIN-BASED METHODS (ISO 21572:2013)
EN ISO 21572:2013 Foodstuffs - Molecular biomarker analysis - Protein-based methods (ISO 21572:2013)
CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

ISO 80000-9:2009 Quantities and units Part 9: Physical chemistry and molecular physics
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 80000-1:2009 Quantities and units — Part 1: General
ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

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Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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