EN 591 : 2001
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
Superseded date
12-01-2009
Superseded by
Published date
01-12-2013
Publisher
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Cooperating organizations
National foreword
Foreword
Specification
1. Scope
2. Definitions
3. Form and presentation of the user manual
4. Content of the user manual
5. Supplementary information
Annex
A. (informative) Bibliography
National annexes
NA. (informative) Committees responsible
NB. (informative) Cross-reference
Specifies the content of user manuals for in vitro diagnostic instruments for professional use. Coverage includes: definitions, content of the user manual, and form and presentation of the user manual.
| Committee |
TC 140
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PN EN 591 : 2004 | Identical |
| I.S. EN 591:2001 | Identical |
| NEN EN 591 : 2001 | Identical |
| NS EN 591 : 2001 | Identical |
| NF EN 591 : 2001 | Identical |
| BS EN 591:2001 | Identical |
| UNI EN 591 : 2001 | Identical |
| UNE-EN 591:2001 | Identical |
| SN EN 591 : 2001 | Identical |
| NBN EN 591 : 2001 | Identical |
| DIN EN 591:2001-07 | Identical |
| I.S. EN 1041:2008+A1:2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| 06/30123163 DC : 0 | BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
| DIN EN ISO 18113-3:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| UNE-EN ISO 18113-3:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| BS EN ISO 18113-3:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use |
| UNI CEI EN 980 : 2009 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| BS EN 375:2001 | Information supplied by the manufacturer with in vitro diagnostic reagents for professional use |
| I.S. EN 592:2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| CEI UNI EN 1041 : 2014 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| DIN EN 1041:2013-12 | Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
| BS ISO 15198:2004 | Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 15198:2004 | Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
| 09/30176675 DC : 0 | BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| 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) |
| UNI CEI EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| I.S. 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) |
| 06/30146511 DC : 0 | BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| UNE-EN 1041:2009 | Information supplied by the manufacturer of medical devices |
| BS EN 1041 : 2008 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| ISO 18113-3:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| I.S. EN 980:2008 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| DIN EN ISO 18113-1:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| BS ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| 06/30146518 DC : 0 | BS ISO 18113-3 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| 06/30122245 DC : 0 | EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| UNI EN ISO 18113-3 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
| I.S. EN ISO 18113-3:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| BS EN 592:2002 | Instructions for use for in vitro diagnostic instruments for self-testing |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
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