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BS EN ISO 18113-5:2024

BS EN ISO 18113-5:2024

$142.49

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

Published By Publication Date Number of Pages
BSI 2024 24
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This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments 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
12 Foreword
13 Introduction
15 1 Scope
2 Normative references
3 Terms and definitions
16 4 Essential requirements
5 Labels and marking
5.1 General
5.2 Identification of the IVD instrument
5.2.1 IVD instrument name
5.2.2 Serial number
5.2.3 In vitro diagnostic use
17 5.2.4 Unique device identifier (UDI)
6 Elements of the instructions for use
18 7 Content of the instructions for use
7.1 Manufacturer
7.2 Identification of the IVD instrument
7.2.1 IVD instrument name
19 7.2.2 Module and software identification
7.3 Intended use/Intended purpose
7.4 Storage and handling
7.5 Warnings and precautions and/or measures to be taken and limitations of use regarding the instrument
20 7.6 Instrument installation
7.6.1 General
7.6.2 Action upon delivery
7.6.3 Bringing into operation
7.7 Principles of measurement
7.8 Performance of the IVD instrument
7.9 Limitations of use
7.10 Preparation prior to operation
21 7.11 Operating procedure
7.12 Control procedure
7.13 Reading of examination results
7.14 Special functions
7.15 Shut-down procedure
22 7.16 Disposal information
7.17 Maintenance
7.18 Troubleshooting
7.19 Follow-up action
7.20 Document control
23 Bibliography

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BS EN ISO 18113-5:2024
$142.49