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BS EN ISO 18113-2:2024

BS EN ISO 18113-2:2024

$142.49

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) – In vitro diagnostic reagents for professional use

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 professional use. 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 self-testing.

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
5 Content of the outer container label
5.1 Manufacturer
5.2 Identification of the in vitro diagnostic (IVD) reagent
5.2.1 IVD reagent name
5.2.2 Batch code/lot number
5.2.3 Unique device identifier (UDI)
17 5.3 Contents
5.4 Intended use/Intended purpose
5.5 In vitro diagnostic use
5.6 Storage, transport, and handling conditions
5.7 Expiry date
18 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
19 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
20 7.2 Identification of the IVD reagent
7.3 Intended use/intended purpose
7.4 Principles of the examination 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
7.8 Reagent preparation
22 7.9 Storage and shelf life after first opening
7.10 Warnings and precautions and/or measures to be taken and limitations of use regarding the device
7.11 Primary sample collection, handling, and storage
23 7.12 Examination procedure
7.13 Control procedure
7.14 Calculation of examination results
7.15 Interpretation of results
7.16 Performance characteristics
7.16.1 Analytical performance characteristics
24 7.16.2 Clinical performance characteristics
7.16.3 Measuring interval
7.17 Biological reference intervals
7.18 Limitations of the examination procedure
7.19 Literature references
7.20 Document control
25 Bibliography

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BS EN ISO 18113-2:2024
$142.49