ISO 18113-4:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
4.1 Essential requirements
4.2 Identification of kit components
4.3 Presentation of the instructions for use
5 Content of the outer container
5.1 Manufacturer
5.2 Identification of the IVD reagent
5.2.1 IVD reagent name
5.2.2 Batch code / lot number
5.2.3 Unique device identifier (UDI)
5.3 Contents
5.4 Intended use/Intended purpose
5.5 In vitro diagnostic use
5.6 Storage and handling conditions
5.7 Expiry date
5.8 Warnings and precautions
6 Content of the immediate container label
6.1 General provisions
6.1.1 Single container
6.1.2 Small label
6.2 Manufacturer
6.3 Identification of the IVD reagent
6.3.1 IVD reagent or component name
6.3.2 Batch code/lot number
6.3.3 Unique device identifier (UDI)
6.4 Contents
6.5 In vitro diagnostic use
6.6 Storage and handling conditions
6.7 Expiry date
6.8 Warnings and precautions
7 Content of the instructions for use
7.1 Manufacturer
7.2 Identification of the IVD reagent
7.3 Intended purpose/Intended use
7.4 Principles of the method
7.5 Traceability of values assigned to calibrators and trueness-control materials
7.6 Components
7.7 Additional required equipment and / or materials
7.8 Storage and shelf life after first opening
7.9 Warnings and precautions
7.10 Primary sample collection, handling and storage
7.11 Procedure to obtain a result
7.12 Control procedure
7.13 Reading of test results
7.14 Interpretation of results
7.15 Performance characteristics
7.15.1 General
7.15.2 Measuring interval
7.16 Biological reference intervals
7.17 Limitations of the procedure
7.18 Literature references
7.19 Document control
Bibliography
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Related Information
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BS EN 13532:2002
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
4.1 Essential requirements
4.2 Identification of kit components
4.3 Presentation of the instructions for use
5 Content of the outer container
5.1 Manufacturer
5.2 Identification of the IVD reagent
5.2.1 IVD reagent name
5.2.2 Batch code / lot number
5.2.3 Unique device identifier (UDI)
5.3 Contents
5.4 Intended use/Intended purpose
5.5 In vitro diagnostic use
5.6 Storage and handling conditions
5.7 Expiry date
5.8 Warnings and precautions
6 Content of the immediate container label
6.1 General provisions
6.1.1 Single container
6.1.2 Small label
6.2 Manufacturer
6.3 Identification of the IVD reagent
6.3.1 IVD reagent or component name
6.3.2 Batch code/lot number
6.3.3 Unique device identifier (UDI)
6.4 Contents
6.5 In vitro diagnostic use
6.6 Storage and handling conditions
6.7 Expiry date
6.8 Warnings and precautions
7 Content of the instructions for use
7.1 Manufacturer
7.2 Identification of the IVD reagent
7.3 Intended purpose/Intended use
7.4 Principles of the method
7.5 Traceability of values assigned to calibrators and trueness-control materials
7.6 Components
7.7 Additional required equipment and / or materials
7.8 Storage and shelf life after first opening
7.9 Warnings and precautions
7.10 Primary sample collection, handling and storage
7.11 Procedure to obtain a result
7.12 Control procedure
7.13 Reading of test results
7.14 Interpretation of results
7.15 Performance characteristics
7.15.1 General
7.15.2 Measuring interval
7.16 Biological reference intervals
7.17 Limitations of the procedure
7.18 Literature references
7.19 Document control
Bibliography