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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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
Superseded date

12-01-2009

Published date

01-12-2013

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Superseded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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