ISO 19001:2013
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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
03-07-2013
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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 |
| Standards | Relationship |
| GOST R ISO 19001 : 2013 | Identical |
| NF EN ISO 19001 : 2013 | Identical |
| NBN EN ISO 19001 : 2013 | Identical |
| NEN EN ISO 19001 : 2013 | Identical |
| NS EN ISO 19001 : 2013 | Identical |
| I.S. EN ISO 19001:2013 | Identical |
| PN EN ISO 19001 : 2013 | Identical |
| SN EN ISO 19001:2013 | Identical |
| UNI EN ISO 19001 : 2013 | Identical |
| SS-EN ISO 19001:2013 | Identical |
| UNE-EN ISO 19001:2013 | Identical |
| BS EN ISO 19001:2013 | Identical |
| EN ISO 19001:2013 | Identical |
| DIN EN ISO 19001:2013-07 | Identical |
| DIN EN 12376:1999-04 | Identical |
| 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 |
| 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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