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CEN
EN ISO 18113-5:2011

EN ISO 18113-5:2011

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Withdrawn date

31-10-2014

Published date

19-10-2011

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential requirements
5 Labels and marking
6 Elements of the instructions for use
7 Content of the instructions for use
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of the EU
         Directive 98/79/EC on "in vitro Diagnostic Medical
         Devices"

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.ISO 18113-5:2009 can also be applied to accessories.

Committee
CEN/TC 140
DevelopmentNote
Supersedes EN 592. (01/2010)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
Supersedes

BS EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use Particular requirements for in vitro diagnostic (IVD) medical equipment
I.S. EN 61010-2-101:2017 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
CEI EN 61010-2-101 : 2003 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN 980:2008 Symbols for use in the labelling of medical devices

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