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BS EN ISO 18113-4:2024

BS EN ISO 18113-4:2024

$142.49

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) – In vitro diagnostic reagents for self-testing

Published By Publication Date Number of Pages
BSI 2024 26
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Annex ZA (informative)Relationship between this European Standard the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
13 Foreword
14 Introduction
15 1 Scope
2 Normative references
3 Terms and definitions
4 General
4.1 Essential requirements
16 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
17 5.2.3 Unique device identifier (UDI)
5.3 Contents
5.4 Intended use/Intended purpose
5.5 In vitro diagnostic use
18 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
19 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
20 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
21 7.5 Traceability of values assigned to calibrators and trueness-control materials
7.6 Components
7.7 Additional required equipment and / or materials
22 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
23 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
24 7.17 Limitations of the procedure
7.18 Literature references
7.19 Document control
25 Bibliography

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BS EN ISO 18113-4:2024
$142.49